An Open Trial of Iloperidone for Mixed Episodes in Bipolar Disorder.

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.

Investigating symptom domains of bipolar disorder for Spanish-speakers using the Bipolar Inventory of Symptoms Scale.

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.

Comparison of outcomes for African Americans, Hispanics, and Non-Hispanic Whites in the CATIE study.

OBJECTIVE: Medication outcome literature in schizophrenia across racial-ethnic groups is sparse, with inconsistent findings. The Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) study provided an opportunity for exploratory analyses of racial-ethnic outcomes. The study objective was to examine race-ethnicity outcomes for CATIE's main outcome (study discontinuation) and secondary outcomes. METHODS: CATIE participants included whites (non-Hispanic) (N=722), African Americans (N=506), and Hispanics (N=170). Survival analyses and mixed-effects regression modeling were conducted, with adjustment for baseline sociodemographic differences and baseline scores of the secondary outcomes. RESULTS: Racial-ethnic groups had unique patterns of outcomes. Hispanics were much more likely to discontinue for lack of efficacy from perphenazine (64% versus 42% non-Hispanic whites and 24% African Americans) and ziprasidone (71% versus 40% non-Hispanic whites and 24% African Americans); Hispanics' quality of life also declined on these medications. Non-Hispanic whites were more likely to discontinue for lack of efficacy in general (averaging olanzapine, quetiapine, and risperidone discontinuation rates). African Americans were less likely to continue after the first phase (32% continuing versus 40% for non-Hispanic whites and 41% Hispanics). Discontinuations were driven by research burden, personal issues, and unspecified loss to follow-up. Non-Hispanic whites had higher depression scores during the follow-up period. African Americans had fewer side effects. CONCLUSIONS: CATIE results did not show disparities favoring non-Hispanic whites. CATIE may have provided state-of-the-art treatment and thus reduced disparate treatments observed in community clinics. African Americans discontinued even after consideration of socioeconomic differences. Why perphenazine and ziprasidone may be less effective with Hispanics should be explored.