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Objectives: To sequentially study the effectiveness of lithium and divalproex monotherapy and adjunctive therapy with quetiapine or lamotrigine in the acute and continuation treatment of bipolar I or II disorder at any phase of illness and at least mild symptom severity., Methods: From June 2011 to December 2016, patients with bipolar I or II disorder (using DSM-IV diagnostic criteria) and CGI-S (Clinical Global Impression-Severity) ⩾ 3 were randomized to receive lithium or divalproex monotherapy for 2 weeks. Patients who had CGI-S-depression ⩾ 3 for 2 weeks at any time after 2-week monotherapy were randomly assigned to receive quetiapine or lamotrigine, or remaining on monotherapy for a total of 26 weeks., Results: The rates of early termination due to lack of efficacy and side effects and changes in BISS (Bipolar Inventory of Symptoms Scale) and CGI-S total score were not significantly different between lithium and divalproex. The completion rate was significantly higher with adjunctive therapy than with monotherapy. BISS and CGI-S total scores, and their sub-scores were significantly reduced with adjunctive therapy compared to monotherapy. Adjunctive therapy significantly increased survival times compared to monotherapy (hazard ratio = 6.8), and the monotherapy group had a significantly increased risk for not reaching sustained recovery from depression (hazard ratio = 12.7). Patients who did not need the 2nd randomization and remained on monotherapy had a significantly reduced hazard for discontinuation (hazard ratio = 3.8)., Conclusions: The efficacy of lithium and divalproex as monotherapy was modest. Adjunctive lamotrigine and quetiapine to either one was well-tolerated and equally effective in reducing bipolar symptomatology, but adjunctive therapy should be initiated as early as possible when depression symptoms are present., Competing Interests: FUNDING SOURCE This study was supported by the National Institute of Mental Health to (CLB and JRC). The grant number is 1P30MH086045–01A2., (Copyright © 1964–2019 by MedWorks Media Inc, Los Angeles, CA All rights reserved. Printed in the United States.)

Background: Mixed mood states in bipolar disorder are difficult to treat and when present indicate worse illness trajectories. Several medications are US Food and Drug Administration approved to treat mixed episodes; however, the clinical trials have been short term and rarely reported depression response., Methods: We conducted a 5-month open-label trial examining the tolerability and efficacy of iloperidone for bipolar disorder mixed episodes., Results: Mania and depression scores significantly improved over the course of the study for study completers (ie, 60%-68% improvement for manic symptoms and 41%-49% for depression symptoms). Improvements were observed early in the trial and after adjusting for concomitant medication effects. The average daily dose in completers was 15 mg. Thirty-nine percent (12/31) of the eligible sample discontinued early because of adverse effects. The adverse events most commonly associated with withdrawal were increased heart rate/palpitations (n = 5 of 12) and urinary incontinence/intense urge to urinate (n = 3 of 12)., Conclusions: In a subset of patients, iloperidone provides relief for classic manic, depression, and irritability symptoms associated with mixed episodes in a long-term trial. Adverse effect profiles are likely to be a major factor contributing to individualized medication use.

Background: A Spanish language rating scale which assesses the range of bipolar disorder symptoms is needed. There are rating scales commonly used, however they do not address commonly expressed symptoms associated with bipolar disorder and have varied rating systems. There are also few comparisons of symptom severity between Spanish and English speaking patients, due to limitations in available rating scales., Methods: We conducted psychometric assessment of the Spanish language Bipolar Inventory of Symptoms Scale (BISS) (N=71) for persons with bipolar disorder, which assesses 5 domains: mania, depression, irritability, anxiety and psychosis. The Spanish BISS scores were then compared to the MADRS (Montgomery Asberg Depression Rating Scale) and the YMRS (Young Mania Rating Scale) as well as to BISS scores in an English speaking sample (N=102) with bipolar disorder from the same geographic locations., Results: Chronbach's alphas for the Spanish BISS ranged from 0.6 to 0.93, with the psychosis domain displaying lower reliability. Correlations with the MADRS and YMRS were good and ranged from 0.70 to 0.88. The BISS differentiated well across mood states in English and Spanish versions, with mood state differentiated well using subscales and domains. For the irritability and anxiety domains, Spanish speaking participants had higher scores than English speakers across mood states. Females showed differences in symptom profiles compared to males., Limitations: The sample sizes in the Spanish speaking manic group were small. The Spanish BISS, tested here primarily in patients of Mexican ancestry, may require revision in other Spanish language populations., Conclusions: The Spanish BISS, a Spanish language symptom rating scale for bipolar disorder, demonstrates good reliability and validity. Clinical assessment in anxiety and irritability domains is particularly relevant in a Spanish speaking sample. Consistent with prior research, females report higher depression, irritability and anxiety scores irrespective of language spoken., (Copyright © 2016. Published by Elsevier B.V.)

Objective: We assessed the spectrum and severity of bipolar symptoms that differentiated bipolar disorder (BD) clinical states, employing the Bipolar Inventory of Symptoms Scale (BISS) which provides a broader item range of traditional depression and mania rating scales. We addressed symptoms differentiating mixed states from depression or mania/hypomania., Method: One hundred and sixteen subjects who met DSM-IV-TR criteria for BD and were currently in a depressed, manic/hypomanic, mixed episode, or recovered state were interviewed using the BISS., Results: A subset of manic items differed between mixed episodes and mania/hypomania or depression. Most anxiety items were more severe in mixed subjects. BISS Depression and Manic subscales differentiated episodes from recovered status. The majority of depression and manic symptoms differentiated mood states in the predicted direction. Mixed episodes had overall greater mood severity than manic/hypomanic episodes or depressed episodes., Conclusion: These results indicate that a small subset of symptoms, several of which are absent in DSM-IV-TR criteria and traditional rating scales for bipolar studies, aid in distinguishing mixed episodes from depressive or manic/hypomanic episodes. The results also support the utility of a comprehensive BD symptom scale in distinguishing primary clinical states of BD., (© 2012 John Wiley & Sons A/S.)

Scales used in studies of bipolar disorder have generally been standardized with major depressive or hospitalized manic patients. A clinician rated scale based on a semi-structured interview for persons with bipolar disorder, with comprehensive coverage of bipolar symptomatology, is needed. We report concurrent, divergent and convergent psychometric reliability, discriminant validity and relationship to a measure of overall function for a new psychometric rating instrument. A primarily outpatient sample of 224 subjects was assessed using the Bipolar Inventory of Symptoms Scale (BISS). The BISS total score and depression and mania subscales were compared to the Young Mania Rating Scale (YMRS), the Montgomery Asberg Depression Rating Scale (MADRS) and the Global Assessment of Functioning Scale (GAF). Clinical mood states were also compared using the BISS. The BISS scores demonstrated good concurrent validity, with estimates (Pearson correlations) ranging from 0.74 to 0.94 for YMRS and MADRS and test-retest reliability from 0.95 to 0.98. BISS concurrent validity with the GAF was significant for four clinical states, but not mixed states. The BISS discriminated primary bipolar mood states as well as subjects recovered for eight weeks compared to healthy controls. In conclusion, the BISS is a reliable and valid instrument broadly applicable in clinical research to assess the comprehensive domains of bipolar disorder. Future directions include factor analysis and sensitivity to change from treatment studies.

Objective: Most rating scales for bipolar disorders (BDs) do not encompass the spectrum of symptomatology now established as characterizing the illness. We report the rationale, format, reliability and initial validity studies of the Bipolar Inventory of Symptoms Scale (BISS), a 44-item scale designed to encompass the spectrum of behavioral disturbances in BDs., Method: Structured video interviews of 20 patients representing four bipolar syndromal subtypes were rated by nine raters., Results: Generally, high inter-rater reliability and internal consistency were established for the depression and mania subscales and the BISS total score. The BISS discriminated across subtypes of bipolar patients with depressed, manic/hypomanic, mixed manic or recovered status., Conclusion: The BISS has adequate reliability, concurrent validity and is capable of discriminating between bipolar subtypes. It also provides a comprehensive scale to assess discrete behavioral components of BD.

Background: This study examines the effectiveness of long-term outpatient psychodynamic group psychotherapy for individuals with bipolar disorder who may have psychiatric comorbidity., Method: The Integrative Outpatient Model (IOM) includes psychoeducation regarding illness, illness management, and exploration of dynamic and interpersonal issues., Results: At one-year follow up, group members had significantly less depressive symptomatology and were less likely to be in a mood episode, compared to controls. There were no between-group differences in manic symptoms or global assessments of functioning. For group-treated patients, the number of days well per week improved significantly; there were no significant improvements in the control group., Conclusions: This pilot study indicates that psychodynamic group psychotherapy is feasible as a component of treatment for bipolar disorder diagnoses. The results suggest benefits on depressive, but not manic symptoms. The 73% retention rate suggests that further study of this treatment is warranted, especially in the cases of patients for whom pharmacotherapy alone is not sufficient.