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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. [ABSTRACT FROM AUTHOR]

Importance: Long-acting injectable antipsychotics (LAIs) can potentially reduce hospitalization risk by enhancing medication adherence but are rarely considered for early-phase schizophrenia treatment.Objective: To determine whether encouraging use of a LAI compared with usual care delays the time to first hospitalization with patients with early-phase illness.Design, Setting, and Participants: The Prevention of Relapse in Schizophrenia (PRELAPSE) trial was cluster randomized with a follow-up duration of 2 years. The study began in December 2014, was completed in March 2019, and was conducted in 39 mental health centers in 19 US states. Site randomization assigned 19 clinics to encourage treatment with long-acting aripiprazole monohydrate (aripiprazole once monthly [AOM] condition) and 20 to provide treatment as usual (clinician's choice [CC] condition). Participant eligibility criteria included (1) schizophrenia diagnosis confirmed by a structured clinical interview, (2) fewer than 5 years of lifetime antipsychotic use, and (3) age 18 to 35 years. The AOM sites identified 576 potentially eligible participants, of whom 234 (40.6%) enrolled; CC sites identified 685 potentially eligible participants, of whom 255 (37.2%) enrolled.Interventions: There were no restrictions on treatment at CC sites (including using LAIs) or at AOM sites with the exception that aripiprazole monohydrate had to be prescribed within US Food and Drug Administration-approved guidelines.Main Outcomes and Measures: The primary outcome was time to first psychiatric hospitalization based on participant interviews every 2 months, the service use resource form administered every 4 months, and other sources (eg, health records) as available. Potential events were adjudicated by an independent committee masked to treatment assignment.Results: The 489 participants (368 men [75.3%]) had a mean (SD) age of 25.2 (4.2) years and 225 (46.0%) had 1 year or less lifetime antipsychotic use. Fifty-two AOM (22%) and 91 CC participants (36%) had at least 1 hospitalization. The mean survival time until first hospitalization was 613.7 days (95% CI, 582.3-645.1 days) for AOM participants and 530.6 days (95% CI, 497.3-563.9 days) for CC participants. For time to first hospitalization, the hazard ratio was 0.56 (95% CI, 0.34- 0.92; P = .02), favoring AOM. Survival probabilities were 0.73 (95% CI, 0.65-0.83) for AOM participants and 0.58 (95% CI, 0.50-0.67) for CC participants. The number needed to treat to prevent 1 additional hospitalization was 7 participants treated with AOM compared with CC.Conclusions and Relevance: Long-acting injectable antipsychotic use by patients with early-phase schizophrenia can significantly delay time to hospitalization, a personally and economically important outcome. Clinicians should more broadly consider LAI treatment for patients with early-phase illness.Trial Registration: ClinicalTrials.gov Identifier: NCT02360319. [ABSTRACT FROM AUTHOR]

Objective: Smoking prevalence rates are elevated in individuals with schizophrenia spectrum disorders (SSD) compared with the general population, with attendant disproportionate smoking-related morbidity and mortality. Pharmacotherapies that improve abstinence rates in this population are underutilized, partly due to concerns about neuropsychiatric safety, particularly for those with comorbid depression or prior suicide attempt. Prospective assessment of the psychiatric safety profile of varenicline in those with SSD is needed.Methods: Adult smokers with SSD entered a 12-week trial of varenicline and behavioral therapy for smoking cessation. Depressive symptoms were assessed with the Calgary Depression Scale for Schizophrenia (CDSS) at baseline and weekly thereafter. Participants with baseline and one or more postbaseline CDSS assessments,n= 179, were included in a secondary analysis of change in depressive symptoms with varenicline treatment, adjusting for abstinence status and baseline depressive symptoms.Results: Twenty-seven percent of participants had a CDSS score at baseline consistent with current major depressive disorder, and more than half had a prior suicide attempt. Forty-one percent (74/179) achieved two or more weeks of continuous abstinence at the end of treatment. CDSS scores declined 31% during the 12-week treatment period. Controlling for baseline CDSS scores, depressive symptoms declined over time in those who completed the trial, independent of abstinence status, and either declined or remained unchanged in those with major depressive disorder or prior suicide attempt or who were taking antidepressant medication. Those who did not complete the trial had no change in depressive symptoms.Discussion: Depressive symptoms declined in adults with schizophrenia during 12 weeks of varenicline treatment and cognitive behavioral therapy, independent of tobacco abstinence. Smokers with SSD who have significant depressive symptoms may be successful in smoking cessation attempts with pharmacotherapeutic aids such as varenicline while maintaining stable psychiatric symptoms. This is a secondary analysis of data collected as part of a clinical trial registered as NCT00621777, atwww.clinicaltrials.gov. [ABSTRACT FROM PUBLISHER]

Importance: More effective treatments are needed for negative symptoms of schizophrenia, which are typi-cally chronic, disabling, and costly. Negative symptoms have previously been associated with reduced blood folate levels, especially among patients with low-functioning variants in genes that regulate folate metabolism, suggesting the potential utility of folate supplementation. Objectives: To determine whether folic acid plus vita-min B12 supplementation reduces negative symptoms of schizophrenia and whether functional variants in folate-related genes influence treatment response. Design: Parallel-group, randomized, double-blind, pla-cebo-controlled clinical trial of 16 weeks of treatment with 2 mg of folic acid and 400 μg of vitamin B12. Setting: Three community mental health centers affili-ated with academic medical centers in the United States. Participants: Outpatients with chronic schizophrenia who were psychiatrically stable but displayed persistent symptoms despite antipsychotic treatment. Eligible pa-tients were 18 to 68 years old, were treated with an an-tipsychotic agent for 6 months or more at a stable dose for 6 weeks or more, and scored 60 or more on the Posi-tive and Negative Syndrome Scale. Intervention: One hundred forty subjects were ran-domized to receive daily oral folic acid plus vitamin B12 or placebo. Main Outcome Measures: Change in negative symp-toms (Scale for the Assessment of Negative Symptoms [SANS]), as well as positive and total symptoms (Posi-tive and Negative Syndrome Scale). Results: Folate plus vitamin Bn improved negative symp-toms significantly compared with placebo (group differ-ence, -- 0.33 change in SANS score per week; 95% CI, -- 0.62 to --0.05) when genotype was taken into ac-count but not when genotype was excluded. An inter-action of the 484C>T variant of FOLH1 (rs202676) with treatment was observed (P=.02), where only patients ho-mozygous for the 484T allele demonstrated signifi-cantly greater benefit with active treatment (--0.59 change in SANS score per week; 95% CI, -0.99 to -0.18). In parallel, we observed an inverse relationship between red blood cell folate concentration at baseline and 484C al-lele load (P= .03), which persisted until 8 weeks of treat-ment. Change in positive and total symptoms did not dif-fer between treatment groups. Conclusions: Folate plus vitamin B12 supplementation can improve negative symptoms of schizophrenia, but treat-ment response is influenced by genetic variation in folate absorption. These findings support a personalized medi-cine approach for the treatment of negative symptoms.*****Trial Registration: clinicaltrials.gov Identifier: NCT00611806 [ABSTRACT FROM AUTHOR]

Background: Psychiatric hospitalization is a major driver of cost in the treatment of schizophrenia. During the first six months after a hospitalization, patients are at increased risk for return to the hospital. Targeting treatment during this period may be especially valuable. Mobilizing a range of treatment enhancements using both smart phones and computers to support patients by individualizing treatment to specific needs may be especially beneficial. The Improving Care Reducing Cost (ICRC) program sought to determine whether a novel, multicomponent, and technologyenhanced approach to relapse prevention in outpatients following a psychiatric hospitalization could reduce days spent in a hospital after discharge. Methods: The ICRC study was a quasi-experimental clinical trial in outpatients with schizophrenia conducted between February 2013 and April 2015 at 10 sites in the US that provide both in and outpatient. Data were obtained from 89 participants who received usual relapse prevention services, followed by a second cohort of 349 participants who received technology-enhanced relapse prevention program. Both groups were followed for 6 months. Patients were between 18 and 60 years old; had a diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder not otherwise specified; and were currently hospitalized or had been hospitalized within the past 30 days at consent. The first cohort received usual care; the second cohort received the Health Technology Program (HTP) a technology-enhanced relapse prevention program. HTP included medication treatment guided by a computer decision support system for the prescriber, a smartphone application for patients that supported medication adherence and other coping strategies, a web-based patient and family psycho-educational intervention, and web-accessed cognitive behavioral therapy for paranoia and hallucinations. A mental health technology coach provided technical support, and developed a personalized, structured, relapse prevention plan with each participant that identified individual relapse precipitants and determined which HTP components should be employed to address them. All patients received computers and Android smartphones to insure access to the interventions. Days spent in a psychiatric hospital during 6 months after discharge was assessed. The Heinrichs Carpenter Quality of Life Scale was completed at baseline and six months. Results: The study included 438 patients. Control participants (N = 89; 37 females) were enrolled first and received usual care for relapse prevention, and followed by 349 participants (128 females) who received the HTP. Days of hospitalization were reduced by 4 days (Mean days: b = -4.25, 95% CI: -8.29; -0.21, P = 0.039) during follow-up in the intervention condition compared to control. Finally, using Heinrichs Carpenter Quality of Life total score at month 6 as an outcome, we found no significant effect of HTP (β = 0.02, t (345) = 0.43, P = 0.668). Discussion: Recently hospitalized patients with schizophrenia who received an integrated technology informed relapse prevention program (HTP) experienced fewer days in the hospital compared to those who received usual care in the six months following their discharge. Given the high patient burden and costs of even a single day spent in a psychiatric hospital, estimated at $1358 per day based on inflation adjusted results from a recent study, our findings imply total savings in psychiatric inpatient expenditures of $5772 during the first 6 months after discharge on average. However, reduction in hospitalization days did not result in a parallel improvement in functioning as assessed by the Quality of Life Scale. Although the control and experimental cohorts were comparable in many characteristics, the quasi–experimental design represented by sequential cohorts rather than a true concurrent randomized controlled trial represents a limitation. The results of the study suggest that technology enhanced treatments that are tailored to patient needs can be implemented in a range of clinical settings in the US to patients at high risk of hospitalization and that the intervention can reduce subsequent hospitalization days. Future research should address limitations in the current study design and will benefit from the development of technology applications that can be available on a single flexible platform. [ABSTRACT FROM AUTHOR]