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Aims: For over 30 years, combined research and treatment settings in the US have been critical to conceptualizing care for first‐episode psychosis (FEP). Here we describe an early example of such a context, the Services for the Treatment of Early Psychosis (STEP) clinic, which is affiliated with the University of Pittsburgh. Methods: We describe STEP's historical roots and establishment in the early 1990s; STEP's research and treatment contributions, alongside its growth and ongoing leadership. Results: Research‐based clinics, like STEP, preceded and helped pave the way for the Recovery After an Initial Schizophrenia Episode project in the US and the ensuing Coordinated Specialty Care (CSC) approach, now widely adopted in the US. Early clinic‐based research at STEP helped establish protocols for psychopharmacology, the relevance of effective early treatment, including psychosocial approaches, and highlighted disparities in treatment outcomes across race/ethnicity. Multidisciplinary collaboration and dialogue with consumers contributed to early treatment, combining psychosocial and pharmacological approaches. STEP adopted CSC and is situated within a bi‐state Learning Health System. STEP has retained a relatively unique 5‐year treatment model and exists within continuum of care ideally suited to studying psychotic illness and treatment outcomes. Conclusions: STEP remains the largest academic FEP clinic in Pennsylvania. Academic FEP clinics like STEP will have a critical role within Learning Health Systems nationally to model participatory approaches, sustain early intervention treatment quality and ongoing treatment developments. [ABSTRACT FROM AUTHOR]

A response from the author of the article "Comprehensive versus usual community care for first-episode psychosis: 2-year outcomes from the NIMH RAISE Early Treatment Program" in the previous issue is presented.

This is Part Two of a report summarizing the proceedings of The Mount Sinai Conference—a gathering of investigators who hoped to reach a consensus about whether the evidence base concerning antipsychotic prescribing for the treatment of schizophrenia was clear enough to support establishing a particular clinical practice as a treatment standard. (Part One covering questions 1–3 appeared in October's issue). [ABSTRACT FROM AUTHOR]

Mitigating rating inconsistency can improve measurement fidelity and detection of treatment response. The International Society for CNS Clinical Trials and Methodology convened an expert Working Group that developed consistency checks for ratings of the Hamilton Anxiety Rating Scale (HAM-A) and Clinical Global Impression of Severity of anxiety (CGI S) that are widely used in studies of mood and anxiety disorders. Flags were applied to 40,349 HAM-A administrations from 15 clinical trials and to Monte Carlo-simulated data as a proxy for applying flags under conditions of inconsistency. Thirty-three flags were derived these included logical consistency checks and statistical outlier-response pattern checks. Twenty-percent of the HAM-A administrations had at least one logical scoring inconsistency flag, 4 % had two or more. Twenty-six percent of the administrations had at least one statistical outlier flag and 11 % had two or more. Overall, 35 % of administrations had at least one flag of any type, 19 % had one and 16 % had 2 or more. Most of administrations in the Monte Carlo- simulated data raised multiple flags. Flagged ratings may represent less-common presentations of administrations done correctly. Conclusions-Application of flags to clinical ratings may aid in detecting imprecise measurement. Flags can be used for monitoring of raters during an ongoing trial and as part of post-trial evaluation. Appling flags may improve reliability and validity of trial data. • A set of expert consensus and statistical flags to help identify possible errors in HAMA ratings. • Flags elaborated in paper can be applied. • Flags represent actual patterns of inconsistencies found. • Application of flags to ratings may improve reliability of ratings and validity of trials. [ABSTRACT FROM AUTHOR]

Abstract: Alpha7 nicotinic acetylcholine receptor (α7 nAChR) agonists may be valuable treatments for negative symptoms and cognitive impairment in schizophrenia. Unfortunately, chronic exposure to an agonist may reduce the receptor's sensitivity. Therefore, we combined CDP-choline, a dietary source of the direct agonist choline, with galantamine, a positive allosteric modulator (PAM) of nicotinic acetylcholine receptors, to improve the efficiency of transducing the choline signal and, possibly, preserve the receptor in a sensitive state. We conducted a single-site, double-blind randomized clinical trial comparing galantamine/CDP-choline to placebos in schizophrenia patients with negative symptoms who were receiving second generation antipsychotics. Forty-three subjects received galantamine and CDP-choline or matching placebos for 16weeks. The primary outcome measure was the 5-item Marder negative-symptoms factor of the Positive and Negative Syndrome Scale (PANSS). Cognition and functioning were also assessed. Trial completion was high; 79%. There was no significant treatment effect on negative symptoms, other PANSS symptom factors, or the MATRICS Cognitive Consensus Battery. There were significant treatment effects in overall functioning and a test of free verbal recall. Three subjects discontinued treatment in the active treatment group for gastro-intestinal adverse events (AE). The most common AE for galantamine/CDP-choline was abdominal pain; for placebo it was headache and sweating. Although there was no significant treatment effect on negative symptoms, the direction of effect mirrored the effects on a cognitive measure and overall functioning. Further study of α7 nAChR agonist/PAMs is warranted in larger studies that will have greater power. [Copyright &y& Elsevier]

Background: Symptom manifestations in mood disorders can be subtle. Cumulatively, small imprecisions in measurement can limit our ability to measure treatment response accurately. Logical and statistical consistency checks between item responses (i.e., cross-sectionally) and across administrations (i.e., longitudinally) can contribute to improving measurement fidelity.Methods: The International Society for CNS Clinical Trials and Methodology convened an expert Working Group that assembled flags indicating consistency/inconsistency ratings for the Hamilton Rating Scale for Depression (HAM-D17), a widely-used rating scale in studies of depression. Proposed flags were applied to assessments derived from the NEWMEDS data repository of 95,468 HAM-D administrations from 32 registration trials of antidepressant medications and to Monte Carlo-simulated data as a proxy for applying flags under conditions of known inconsistency.Results: Two types of flags were derived: logical consistency checks and statistical outlier-response pattern checks. Almost thirty percent of the HAMD administrations had at least one logical scoring inconsistency flag. Seven percent had flags judged to suggest that a thorough review of rating is warranted. Almost 22% of the administrations had at least one statistical outlier flag and 7.9% had more than one. Most of the administrations in the Monte Carlo- simulated data raised multiple flags.Limitations: Flagged ratings may represent less-common presentations of administrations done correctly.Conclusions: Application of flags to clinical ratings may aid in detecting imprecise measurement. Reviewing and addressing these flags may improve reliability and validity of clinical trial data. [ABSTRACT FROM AUTHOR]

International Society for CNS Clinical Trials and Methodology convened an expert Working Group that assembled consistency/inconsistency flags for the Personal and Social Performance Scale (PSP). One hundred and forty seven flags were identified, 16 flag errors in deriving the PSP decile (i.e., total) score from the four individual domain scores, 74 flag inconsistencies between domain scores relative to Positive and Negative Symptom Scale (PANSS) item ratings and 57 flag inconsistencies between PSP decile score and PANSS items ratings. The flags were applied to assessments from randomized clinical trial data of antipsychotics in schizophrenia from almost 18,000 ratings. Twenty-two flags were raised in at least 5 of 1000 ratings. Nearly 20% of the PSP ratings had at least one inconsistency flag raised. Application of flags to clinical ratings may improve the reliability of ratings and validity of trials. [ABSTRACT FROM AUTHOR]

Introduction: Little attention has been paid to the contribution of individual residual symptom to predict relapse in patients with schizophrenia receiving oral or long-acting injectable (LAI) antipsychotics.Method: We used the data from the Preventing Relapse on Oral Antipsychotics Compared to Injectables - Evaluating Efficacy (PROACTIVE) study, in which 305 outpatients with schizophrenia were randomly allocated to either biweekly LAI-risperidone (LAI-R) or daily oral second-generation antipsychotics (SGA) and assessed for up to 30 months. Baseline individual symptoms that could predict subsequent relapse were identified, using a Cox proportional hazards model. Moreover, among those who relapsed during the study (n = 73), individual symptoms were compared between baseline and biweekly ratings 8 to 2 weeks before relapse, using the linear mixed model.Results: A greater score in grandiosity at baseline was significantly associated with subsequent relapse (adjusted HR = 1.24, p = 0.006). When the two treatment groups were separately analyzed, more severe grandiosity (adjusted HR = 1.43, p = 0.003) and less severe hallucinatory behavior (adjusted HR = 0.70, p = 0.013) at baseline were significantly associated with relapse in the oral SGA group, but none was identified in the LAI-R group. Emotional withdrawal was significantly worse 8 and 2 weeks before relapse compared to the baseline (p = 0.032 and p = 0.043, respectively).Discussion: More severe grandiosity and less hallucination may have led to more frequent relapses in patients with schizophrenia receiving oral antipsychotics, which was not a case in those receiving LAI-R. The exploratory analysis indicates an increase in emotional withdrawal before relapse may be a useful marker for earlier interventions to possibly avert relapse. [ABSTRACT FROM AUTHOR]

Introduction: Technology-delivered healthcare interventions may enhance dissemination of evidence-based treatments in low-resource areas. These interventions may be accessed 'on-demand,' including after hours. Patients with schizophrenia do engage with technological aids but when/how they would utilize these tools is not known.Methods: We conducted a large, prospective, ten-site, longitudinal study of four technology-assisted interventions for patients with schizophrenia spectrum disorders within 60 days of psychiatric hospital discharge, a high risk period. One tool employed was a smartphone intervention called 'FOCUS,' which could be used by patients as needed, providing help in five content areas: medications, mood, social, sleep and voices. Each login was date- and time-stamped as occurring during normal clinic hours, or 'off-hours,' and the pattern of use described.Results: 347 of 368 patients utilized FOCUS during the 6-month study. There were a total of 75,447 FOCUS logins; 35,739 (47.4%) were self-initiated and 38,139 (50.6%) were off-hours. 18,450 of the logins during off-hours were self-initiated (24.5%). No differences in average usage per month were found based on race/ethnicity. A subset of 'high utilizers' (n = 152, 43.8%) self-initiated use of all five FOCUS modules both on- and off-hours. They tended to be women, >35 years old, and had a high school diploma or greater.Conclusion: Most patients with schizophrenia spectrum disorders recently discharged from the hospital utilized a smartphone intervention targeted to address troublesome residual symptoms. One quarter of the total smartphone utilization was self-initiated off-hours, indicating the potential utility of this tool to extend support for patients during periods of elevated risk. [ABSTRACT FROM AUTHOR]

The NAVIGATE program was developed for the Recovery After Initial Schizophrenia Episode-Early Treatment Program (RAISE-ETP) study, which compared NAVIGATE to usual Community Care in a cluster randomized design involving 34 sites and 404 patients. This article describes the approach to training and implementing the NAVIGATE program at the 17 sites (including 134 practitioners) randomized to provide it, and to evaluating the fidelity of service delivery to the NAVIGATE model. Fidelity was evaluated to five different components of the program, all of which were standardized in manuals in advance of implementation. The components included four interventions (Individualized Resiliency Training, Family Education Program, Supported Employment and Education, Personalized Medication Management) and the overall organization (staffing and structure) of the NAVIGATE team. Most of the sites demonstrated acceptable or higher levels of fidelity in their implementation of the four interventions and the organization of the program, with all 17 sites demonstrating at least acceptable overall fidelity to the NAVIGATE program. The results indicate that the NAVIGATE program can be implemented with good fidelity to the treatment model in a diverse array of community mental health care settings serving persons with a first episode psychosis. [ABSTRACT FROM AUTHOR]

Background: Schizophrenia is a chronic disabling disorder for which current treatments are only partially effective. While the evaluation of novel interventions is a high priority, loss to follow-up is a major threat to validity.Methods: Pattern mixture modeling is a statistical technique that incorporates information on patterns of retention that may bias comparisons between randomized treatment groups. This study used pattern mixture mixed model (PMMM) in the analysis of outcomes of a two-year cluster-randomized trial, the Recovery after an Initial Schizophrenia Episode-Early Treatment Program, which compared a coordinated specialty care intervention called NAVIGATE to usual community care (CC). PMM-adjusted outcome differences between NAVIGATE and CC were estimated by the weighted-average of effects across the retention patterns.Results: Compared to the original analysis, PMMM improved model fit and the estimated effectiveness of NAVIGATE as compared to CC. On the Quality of Life Scale NAVIGATE effectiveness increased by 1.50 points (25.4%); on the Positive and Negative Syndrome Scale, by 1.72 points (39.8%), and on the Calgary Depression Scale by 0.49 points (62.1%). PMMM did not improve model fit for employment days, substance use days, or hospital days.Conclusion: Use of PMMM improved model fit and increased the estimated differences between NAVIGATE and CC for major outcomes. Patients with differential retention patterns may have different outcome trajectories. PMMM is a useful tool for addressing potential biases arising from these differences. [ABSTRACT FROM AUTHOR]

Background: We assessed the prevalence and correlates of lifetime substance use disorders in people with first episode psychosis using the baseline data from the Recovery After an Initial Schizophrenia Episode (RAISE) Early Treatment Program study.Methods: Research staff assessed 404 first episode patients at 34 community mental health centers across the United States with the Structured Clinical Interview for DSM-IV for diagnoses of psychotic and substance use disorders. Logistic regression was used to evaluate the relationships between participant characteristics and lifetime substance use disorders, followed with generalized linear mixed-effects regression models to identify unique predictors of lifetime substance use disorders.Results: Approximately one-third of participants reported recent alcohol use (36.6%) and cannabis use (30.7%), and one half (51.7%) met criteria for any lifetime alcohol or drug use disorder. Lifetime substance use disorders were associated with male gender, White race, higher excited (hyperactivity, mood lability, impulsivity, hostility, and uncooperativeness), psychotic and depressive symptoms, less impaired cognition, and greater perceived stigma. Gender, race, and excited symptoms were the most consistent unique predictors of lifetime substance use disorders found in multivariate analyses.Conclusions: Half of first episode psychosis patients have co-occurring substance use disorders, which are associated with both more severe symptoms and greater perceptions of stigma. Programs aiming to serve these patients must have the skills and clinical strategies to help people with these unique characteristics. [ABSTRACT FROM AUTHOR]

Objective: Evaluate the effect of paliperidone palmitate once-monthly (PP1M) injectable on the specific functioning domains of the Personal and Social Performance (PSP) scale in patients with schizoaffective disorder (SCA) participating in a long-term study.Methods: This study (NCT01193153) included both in- and outpatient subjects with SCA experiencing an acute exacerbation of psychotic and mood symptoms. Subjects were treated with PP1M either as monotherapy or in combination with antidepressants or mood stabilizers during a 25-week open-label (OL) phase. Stabilized subjects were randomly assigned 1:1 (PP1M or placebo) into a 15-month double-blind (DB) relapse-prevention period. Functioning of the randomized subjects during OL and DB phases was evaluated using the PSP scale (four domains: socially useful activities, personal/social relationships, self-care, and disturbing/aggressive behaviors). Three statistical approaches were utilized to analyze PSP scores to assess robustness and consistency of findings. No adjustments were made for multiplicity.Results: 334 of 667 enrolled subjects were stabilized with PP1M, randomly assigned to PP1M (n=164) or placebo (n=170) in the DB phase, and included in this analysis. Improvements in all PSP domain scores were observed during the OL phase and were maintained during the DB phase with PP1M, but decreased with placebo. Differences compared to placebo were significant in all four PSP domains during the DB phase (P≤0.008).Conclusion: The analysis in this study showed that PP1M improves functioning, as measured by the four PSP domain scores, in symptomatic subjects with SCA. Functioning was maintained compared with placebo. [ABSTRACT FROM AUTHOR]

Background: Participation in work and school are central objectives for first episode psychosis (FEP) programs, but evidence effectiveness has been mixed in studies not focused exclusively on supported employment and education (SEE). Requirements for current motivation to work or go to school limit the generalizability of such studies.Methods: FEP participants (N=404) at thirty-four community treatment clinics participated in a cluster randomized trial that compared usual Community Care (CC) to NAVIGATE, a comprehensive, team-based treatment program that included ≥5h of SEE services per week, , grounded in many of the principles of the Individual Placement and Support model of supported employment combined with supported education services. All study participants were offered SEE regardless of their initial interest in work or school. Monthly assessments over 24months recorded days of employment and attendance at school, days of participation in SEE, and both employment and public support income (including disability income). General Estimation Equation models were used to compare CC and NAVIGATE on work and school participation, employment and public support income, and the mediating effect of receiving ≥3 SEE visits on these outcomes.Results: NAVIGATE treatment was associated with a greater increase in participation in work or school (p=0.0486) and this difference appeared to be mediated by SEE. No group differences were observed in earnings or public support payments.Conclusion: A comprehensive, team-based FEP treatment approach was associated with greater improvement in work or school participation, and this effect appears to be mediated, in part, by participation in SEE. [ABSTRACT FROM AUTHOR]

Abstract: The regionally selective reduction of expression of the α7 nicotinic acetylcholine receptor (α7 nAChR) in schizophrenia underlies impaired sensory inhibition, a possible endophenotype of the disorder. This ligand-gated ion channel receptor has been proposed as a pharmacotherapeutic target in schizophrenia. The current study examined the effect of CDP-choline alone and the combination of CDP-choline and galantamine, administered acutely and once-daily for five consecutive days, in an animal model of NMDA receptor hypofunction that is relevant to schizophrenia. The results support the allosteric modulatory influence of galantamine on CDP-choline; however, individual doses of CDP-choline and galantamine must be carefully titrated in order to achieve optimal levels of α7 nAChR “agonism” that may be necessary for the desired therapeutic effect. [Copyright &y& Elsevier]

Objetivo: A menudo los pacientes con esquizofrenia se presentan con síntomas negativos y déficit cognitivos para los que no se dispone de tratamientos efectivos. Se ha sugerido que los agentes que actúan en el sitio de la glicina del receptor glutamatérgico del ácido N-metil-D-aspártico (NMDA) son tratamientos prometedores para los síntomas negativos de moderados a graves y para los déficit cognitivos. Método: El Cognitive and Negative Symptoms in Schizophrenia Trial (CONSIST) fue un ensayo clínico aleatorizado con doble enmascaramiento, doble simulación y grupos paralelos de tratamiento adyuvante con glicina, D-cicloserina o placebo llevado a cabo en cuatro centros de EE.UU. y uno de Israel. Los participantes fueron 157 pacientes hospitalizados y ambulatorios que cumplieron los criterios de esquizofrenia o trastorno esquizoafectivo del DSM-IV y criterios retrospectivos y prospectivos de síntomas negativos de moderados a graves sin síntomas positivos, depresivos o extrapiramidales importantes. Los criterios de valoración principales fueron el promedio de «índice de cambio» en las puntuaciones totales de la Escala de Evaluación de Síntomas Negativos (SANS) y el cambio en el promedio de las puntuaciones z en el dominio cognitivo. Resultados: No se observaron diferencias significativas en el cambio de la puntuación total de la SANS entre los individuos que recibieron glicina y los que recibieron placebo ni entre los que tomaron D-cicloserina y los que tomaron placebo. Una prueba preespecificada para la interacción entre centro, tratamiento y tiempo resultó significativa en las pruebas post hoc. Un centro mostró una reducción mayor en la puntuación total de la SANS para los pacientes que recibieron D-cicloserina frente a los que recibieron placebo. En un segundo centro se constató una mayor reducción en la puntuación total de la SANS en los pacientes que recibieron placebo frente a los que recibieron glicina. No hubo diferencias significativas entre la glicina o el placebo, ni entre los individuos que recibieron cicloserina y los que recibieron placebo, en el promedio de la puntuación z de la cognición. Conclusiones: Los resultados de este estudio sugieren que ni la glicina ni la D-cicloserina son alternativas terapéuticas generalmente efectivas para tratar los síntomas negativos o los déficit cognitivos. [ABSTRACT FROM AUTHOR]

Objective: Patients with schizophrenia frequently present with negative symptoms and cognitive impairments for which no effective treatments are known. Agents that act at the glycine site of the N-methyl-D-aspartic acid (NMDA) glutamatergic receptor have been suggested as promising treatments for moderate to severe negative symptoms and cognitive impairments. Method: The Cognitive and Negative Symptoms in Schizophrenia Trial (CONSIST) was a 16-week double-blind, double-dummy, parallel group, randomized clinical trial of adjunctive glycine, D-cycloserine, or placebo conducted at four sites in the United States and one site in Israel. The participants were 157 inpatients and outpatients who met DSM-lV criteria for schizophrenia or schizoaffective disorder and retrospective and prospective criteria for moderate to severe negative symptoms without marked positive, depressive, or extrapyramidal symptoms. The primary outcome measures were the average ‘rate of change’ of Scale for the Assessment of Negative Symptoms (SANS) total scores and change in the average cognitive domain z scores. Results: There were no significant differences in change in the SANS total score between glycine and placebo subjects or D-cycloserine and placebo subjects. A pre-specified test for the site-by-treatment-by-time interaction was significant in post hoc tests. One site had greater reduction in the SANS total score for patients receiving D-cycloserine relative to patients receiving placebo. A second site had greater reduction in the SANS total score for placebo patients compared with glycine patients. There were no significant differences between glycine and placebo or D-cycloserine and placebo subjects on the average cognition z score. Conclusions: The study results suggest that neither glycine nor D-cycloserine is a generally effective therapeutic option for treating negative symptoms or cognitive impairments. [ABSTRACT FROM AUTHOR]

Objective: The authors compared 4-month treatment outcomes for olanzapine versus risperidone in patients with first-episode schizophrenia spectrum disorders. Method: One hundred twelve subjects (70% male; mean age=23.3 years [SD = 5.1]) with first-episode schizophrenia (75%), schizophreniform disorder (17%), or schizoaffective disorder (8%) were randomly assigned to treatment with olanzapine (2.5–20 mg/day) or risperidone (1–6 mg/day). Results: Response rates did not significantly differ between olanzapine (43.7%, 95% Cl=28.8%–58.6%) and risperidone (54.3%, 95% C1=39.9%–68.7%). Among those responding to treatment, more subjects in the olanzapine group (40.9%, 95% Cl=16.8%–65.0%) than in the risperidone group (18.9%, 95% Cl=0%–39.2%) had subsequent ratings not meeting response criteria. Negative symptom outcomes and measures of parkinsonism and akathisia did not differ between medications. Extrapyramidal symptom severity scores were 1.4 (95% CI=1.2–1.6) with risperidone and 1.2 (95% CI=1.0–1.4) with olanzapine. Significantly more weight gain occurred with olanzapine than with risperidone: the increase in weight at 4 months relative to baseline weight was 17.3%(95% CI=14.2%–20.5%) with olanzapine and 11.3% (95% Cl=8.4%–14.3%) with risperidone. Body mass index at baseline and at 4 months was 24.3 (95% Cl=22.8–25.7) versus 28.2 (95% Cl=26.7–29.7) with olanzapine and 23.9 (95% Cl=22.5–25.3) versus 26.7 (95% Cl=25.2–28.2) with risperidone. Conclusions: Clinical outcomes with risperidone were equal to those with olanzapine, and response may be more stable. Olanzapine may have an advantage for motor side effects. Both medications caused substantial rapid weight gain, but weight gain was greater with olanzapine. [ABSTRACT FROM AUTHOR]

Objective: Duration of untreated psychosis is associated with time to treatment response among patients with schizophrenia. However, individual psychotic symptoms have not been investigated in this context. The authors examined the relationship between duration of untreated psychosis and time to response for hallucinations and delusions. Method: Data were available for 118 patients with first-episode schizophrenia in a longitudinal treatment study. Patients received open-label treatment with conventional antipsychotics and were followed for up to 5 years. Duration of untreated psychosis was correlated with time to response for delusions and hallucinations, and predictors of time to response were examined. Results: Time to response for delusions was significantly longer than that for hallucinations. Duration of untreated psychosis was significantly correlated with time to response for delusions but not for hallucinations. In regression analyses, duration of untreated psychosis was the only predictor for time to response for delusions; it was not a predictor for hallucinations. Conclusions: The results suggest that duration of untreated psychosis may be specifically associated with time to response for delusions. This association may have clinical implications. [ABSTRACT FROM AUTHOR]

Objective: The purpose of this investigation was to evaluate the effects of clozapine and rispericlone on spatial working memory in patients with schizophrenia. Method: Spatial working memory performance was evaluated at baseline and after 17 and 29 weeks in 97 patients with schizophrenia participating in a multisite trial. Results: Compared with baseline performance while receiving conventional antipsychotic medication, risperidone improved, and clozapine worsened, spatial working memory performance. Conclusions: The differential effects of these medications on spatial working memory may be due to the anticholinergic effects of clozapine and prefrontal dopamine-enhancing effects of risperidone. [ABSTRACT FROM AUTHOR]

Los autores compararon los patrones y la especificidad de las dimensiones de la personalidad premorbidas de los pacientes con un primer episodio de esquizofrenia con los patrones de pacientes con un primer episodio de psicosis no esquizofrénica y de individuos sanos de control. Método: Se evaluaron 63 pacientes con un primer episodio de esquizofrenia y trastornos psicóticos afines, 34 pacientes con un primer episodio de psicosis no esquizofrénica y 77 individuos sanos de control con la Personality Disorder Evaluation, una entrevista semiestructurada que mide las dimensiones de la personalidad. Resultados: Las puntuaciones en las dimensiones del grupo A y del grupo C-en concreto, la puntuación correspondiente a la personalidad por evitación-fueron más altas en los pacientes con esquizofrenia, y las puntuaciones en las dimensiones del grupo B fueron más elevadas en los pacientes con psicosis no esquizofrénica. Las puntuaciones en las dimensiones del grupo C, en particular la puntuación correspondiente a la personalidad por evitación, se relacionaron intensamente con todas las puntuaciones en las dimensiones del grupo A. Conclusiones: La relación que se observa entre la personalidad por evitación y la esquizofrenia apoya los datos recientes sobre la comorbilidad de los trastornos de la personalidad no pertenecientes al espectro en la esquizofrenia. Esta comorbilidad podría estar relacionada con determinadas aIteraciones compartidas de la cognición social, de origen neuroevolutivo, en la esquizofrenia y con determinadas dimensiones de la personalidad del grupo C. [ABSTRACT FROM PUBLISHER]

Objective: The authors compared the patterns and specificity of premorbid personality dimensions in first-episode schizophrenia patients with those in patients with first-episode nonschizophrenia psychoses and healthy comparison subjects. Method: A series of 63 patients with first-episode schizophrenia and related psychotic disorders, 34 patients with first-episode nonschizophrenia psychoses, and 77 healthy comparison subjects were assessed with the Personality Disorder Evaluation, a semistructured interview schedule that measures personality dimensions. Results: Cluster A as well as cluster C dimensional scores-in particular, the avoidant personality score-were higher for the schizophrenia patients, and cluster B dimensional scores were higher for the patients with nonschizophrenia psychoses. Cluster C dimensional scores, particularly the avoidant personality score, were highly intercorrelated with all cluster A dimensional scores. Conclusions: The observed association between avoidant personality and schizophrenia supports the recent literature on the comorbidity of nonspectrum personality disorders in schizophrenia. This association may be related to shared neurodevelopmentally mediated impairments in social cognition in schizophrenia and some cluster C personality dimensions. [ABSTRACT FROM AUTHOR]

Objective: Schizophrenia is associated with several chronic physical illnesses and a shorter life expectancy, compared with life expectancy in the general population. One approach to improving the health of patients with schizophrenia is to improve the monitoring of physical health that occurs in psychiatric settings. The authors discuss a consensus panel's recommendations for improving the physical health monitoring of patients with schizophrenia who are treated in outpatient settings. Method: A consensus meeting including psychiatric and other medical experts assembled on October 17-18, 2002, to evaluate the existing literature and to develop recommendations for physical health monitoring of patients with schizophrenia. Conference participants reviewed the literature in the following areas: 1) weight gain and obesity; 2) diabetes; 3) hyperlipidemia; 4) prolongation of the QT interval on the ECG; 5) prolactin elevation and related sexual side effects; 6) extrapyramidal side effects, akathisia, and tardive dyskinesia; 7) cataracts; and 8) myocarditis. Experts for each topic area formulated monitoring recommendations that were discussed by all of the participants until a consensus was reached. Results: Consensus recommendations included regular monitoring of body mass index, plasma glucose level, lipid profiles, and signs of prolactin elevation or sexual dysfunction. Information from monitoring should guide the selection of anti psychotic agents. Specific recommendations were made for cardiac monitoring of patients who receive medications associated with QT interval prolongation, including thioridazine, mesoridazine, and ziprasidone, and for monitoring for signs of myocarditis in patients treated with dozapine. Patients who receive both first- and second-generation antipsychotic medications should be examined for extrapyramidal symptoms and tardive dyskinesia. Patients with schizophrenia should receive regular visual examinations. Conclusions: The conference participants recommended that mental health care providers perform physical health monitoring that typically occurs in primary care settings for their patients who do not receive physical health monitoring in those settings. This change in usual practice is recommended on the basis of the conference participants' belief that this additional monitoring will result in the earlier detection of common, serious risk factors that could, without detection and intervention, contribute to impaired health of patients with schizophrenia. [ABSTRACT FROM AUTHOR]

Objective: Neurological abnormalities are frequently seen in patients with first episode psychotic disorders but are generally considered to be diagnostically nonspecific, neurologically nonlocalizing, and, hence, "soft." This study examined the neuroanatomical correlates and diagnostic specificity of abnormal findings on the neurological examination in first-episode schizophrenia and other psychotic disorders. Method: Neuroleptic-naive patients with schizophrenia (N=90) and with nonschizophrenia psychoses (N=39) and carefully matched healthy subjects (N=93) were compared on total and factor scores for a reliable subset of Neurological Evaluation Scale items. The relationship between neurological examination abnormalities and alterations in the relevant brain structures as assessed by magnetic resonance imaging was examined in a subset of subjects. Results: Factor scores for repetitive motor task abnormalities were higher in both patient groups, relative to the healthy group, and did not distinguish between the patient groups. Factor scores for abnormalities in cognitively demanding and perceptual tasks were markedly higher in the schizophrenia group, relative to both comparison groups, and were not different between the nonschizophrenia psychoses group and the healthy comparison group. Higher scores for the cognitive/perceptual abnormalities factor were correlated with smaller volumes of the left heteromodal association cortex. Conclusions: Neurological signs may serve as expedient bedside measures that are potentially useful in the assessment of idiopathic psychoses, and cognitive/ perceptual neurological signs may have a measure of diagnostic specificity. These findings provide neurobiological validation of abnormal findings on the neurological examination. These abnormalities may reflect discrete neuroanatomical alterations in schizophrenia and may have a localizing value. [ABSTRACT FROM AUTHOR]

Reports the arguments on prescribing antipsychotic medications for treating schizophrenia in the U.S. Controversy on efficacy of antipsychotics; Evidence on the safety of ziprasidone; Concern on the reaction of patients treated with antipsychotic medications. INSETS: Antipsychotic treatment evaluated for prodromal schizophrenia.;FDA issues 'approvable letter' for aripiprazole..

he original purposes of the American Psychological Association's (APA's) Committee for the Protection of Human Participants in Research (CPHPR), the new purposes of the CPHPR under its new name, the Committee on Standards in Research (CSR) and the scientific and social zeitgeist that has occasioned this change are described. Also several areas of concern about research ethics that are of special interest to the current members of the CSR are identified, and communications between the CSR and APA members on these issues are encouraged. [ABSTRACT FROM PUBLISHER]

Objective: Insomnia is a common comorbidity in schizophrenia. Increasing cross-sectional evidence suggests an association between insomnia and suicidal ideation (SI) and symptom severity in schizophrenia. We investigated longitudinal associations over 3 months between insomnia, suicidal ideation, and symptom severity in a group of patients with chronic schizophrenia., Method: We performed a secondary analysis of data from n = 305 participants from the Preventing Relapse Oral Antipsychotics Compared to Injectables Evaluating Efficacy (PROACTIVE) schizophrenia trial using regression models., Results: The prevalence of moderate-to-severe insomnia was 17.7 % at baseline and 13.6 % at 3 months, respectively. The prevalence of SI was 22 % at baseline and 22.5 % at 3 months. After controlling for potential confounders, improved SI from baseline to 3 months was associated with both baseline moderate-to-severe insomnia (OR = 3.81, 95 % CI 1.11-13.12, p = 0.034) and improvement in insomnia (OR = 3.50, 95 % CI 1.23-9.92, p = 0.013). Worsening SI from baseline to 3 months was associated with worsening insomnia (OR = 3.50, 95 % CI 1.23-9.92, p = 0.013), but not baseline insomnia. Improvement in BPRS total score from baseline to 3 months was associated with improvement in insomnia (β = 0.17, p = 0.029), but not baseline insomnia., Conclusion: Insomnia is common in patients with chronic schizophrenia and insomnia showed significant associations with SI and psychopathology. Clinicians should consider insomnia when assessing suicide risk in patients with schizophrenia., Competing Interests: Declaration of competing interest Mr. Ketcham declares no financial interests or potential conflicts of interest related directly or indirectly to this work. Dr. Schooler declares no financial interests or potential conflicts of interest related directly or indirectly to this work. Ms. Severe declares no financial interests or potential conflicts of interest related directly or indirectly to this work. Dr. Buckley declares no financial interests or potential conflicts of interest related directly or indirectly to this work. Dr. B. Miller declares no financial interests or potential conflicts of interest related directly or indirectly to this work. In the past 12 months, Dr. Miller received research support from Augusta University, the National Institute of Mental Health, and the Stanley Medical Research Institute; and Honoraria from Atheneum, Carlat Psychiatry, Clearview, and Psychiatric Times., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Background: Psychiatric hospitalization is a major driver of cost in the treatment of schizophrenia. Here, we asked whether a technology-enhanced approach to relapse prevention could reduce days spent in a hospital after discharge., Methods: The Improving Care and Reducing Cost (ICRC) study was a quasi-experimental clinical trial in outpatients with schizophrenia conducted between 26 February 2013 and 17 April 2015 at 10 different sites in the USA in an outpatient setting. Patients were between 18 and 60 years old with a diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder not otherwise specified. Patients received usual care or a technology-enhanced relapse prevention program during a 6-month period after discharge. The health technology program included in-person, individualized relapse prevention planning with treatments delivered via smartphones and computers, as well as a web-based prescriber decision support program. The main outcome measure was days spent in a psychiatric hospital during 6 months after discharge., Results: The study included 462 patients, of which 438 had complete baseline data and were thus used for propensity matching and analysis. Control participants ( N = 89; 37 females) were enrolled first and received usual care for relapse prevention followed by 349 participants (128 females) who received technology-enhanced relapse prevention. During 6-month follow-up, 43% of control and 24% of intervention participants were hospitalized (χ2 = 11.76, p<0.001). Days of hospitalization were reduced by 5 days (mean days: b = -4.58, 95% CI -9.03 to -0.13, p = 0.044) in the intervention condition compared to control., Conclusions: These results suggest that technology-enhanced relapse prevention is an effective and feasible way to reduce rehospitalization days among patients with schizophrenia.

To examine long-term effects of early intervention services (EIS) for first-episode psychosis, we compared Heinrichs-Carpenter Quality of Life (QLS) and Positive and Negative Syndrome Scale (PANSS) scores and inpatient hospitalization days over 5 years with data from the site-randomized RAISE-ETP trial that compared the EIS NAVIGATE (17 sites; 223 participants) and community care (CC) (17 sites; 181 participants). Inclusion criteria were: age 15-40 years; DSM-IV diagnoses of schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, or psychotic disorder not otherwise specified; first psychotic episode; antipsychotic medication taken for ≤6 months. NAVIGATE-randomized participants could receive NAVIGATE from their study entry date until NAVIGATE ended when the last-enrolled NAVIGATE participant completed 2 years of treatment. Assessments occurred every 6 months. 61% of participants had assessments conducted ≥2 years; 31% at 5 years. Median follow-up length was CC 30 months and NAVIGATE 38 months. Primary analyses assumed data were not-missing-at-random (NMAR); sensitivity analyses assumed data were missing-at-random (MAR). MAR analyses found no significant treatment-by-time interactions for QLS or PANSS. NMAR analyses revealed that NAVIGATE was associated with a 13.14 (95%CI:6.92,19.37) unit QLS and 7.73 (95%CI:2.98,12.47) unit PANSS better improvement and 2.53 (95%CI:0.59,4.47) fewer inpatient days than CC (all comparisons significant). QLS and PANSS effect sizes were 0.856 and 0.70. NAVIGATE opportunity length (mean 33.8 (SD = 5.1) months) was not associated (P = .72) with QLS outcome; duration of untreated psychosis did not moderate (P = .32) differential QLS outcome. While conclusions are limited by the low rate of five-year follow-up, the data support long-term benefit of NAVIGATE compared to community care., (© The Author(s) 2022. Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center. All rights reserved. For permissions, please email: journals.permissions@oup.com.)