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Introduction: We developed models of Specialized Care for Bipolar Disorder (SCBD) and a psychosocial treatment [Enhanced Clinical Intervention (ECI)] that is delivered in combination with SCBD. We investigated whether SCBD and ECI + SCBD are able to improve outcomes and reduce health disparities for young and elderly individuals, African Americans, and rural residents with bipolar disorder., Method: Subjects were 463 individuals with bipolar disorder, type I, II, or not otherwise specified, or schizoaffective disorder, bipolar type, randomly assigned to SCBD or ECI + SCBD and followed longitudinally for a period of one to three years at four clinical sites., Results: Both treatment groups significantly improved over time, with no significant differences based on age, race, or place of residence, except for significantly greater improvement among elderly versus adult subjects. Improvement in quality of life was greater in the ECI + SCBD group. Of the 299 participants who were symptomatic at study entry, 213 achieved recovery within 24 months, during which 86 of the 213 subjects developed a new episode. No significant difference was found for race, place of residence, or age between the participants who experienced a recurrence and those who did not. However, the adolescent patients were less likely than the adult and elderly patients to experience a recurrence., Conclusion: This study demonstrated the effectiveness of SCBD and the additional benefit of ECI independent of age, race, or place of residence. It also demonstrated that new mood episodes are frequent in individuals with bipolar disorder who achieve recovery and are likely to occur in spite of specialized, guideline-based treatments.

Objective: This study was aimed at evaluating general medical burden in a group of 111 patients with bipolar I disorder., Methods: Data were drawn from participants entering the Bipolar Disorder Center for Pennsylvanians (BDCP) protocol. General medical burden was assessed by completing the Cumulative Illness Rating Score (CIRS) from chart review., Results: The mean age of the sample was 42.1 (11.5), mean CIRS total score was 4.7 (2.9), and mean number of categories endorsed was 3.4 (1.7). Medical burden showed a positive relationship with increasing age and with duration of illness. CIRS scores and number of organ/system categories endorsed were significantly higher in patients with more than 21 years of illness than in patients with 0-9 years of illness (p<.0001) or with 10-20 years of illness (p<.0001). Medical burden was related to duration of illness even after controlling for age. The most frequently endorsed illness categories were cardiovascular disease, (with hypertension and hyperlipidemia being the most frequent conditions) and endocrine/metabolic (with obesity, thyroid dysfunction, and type 2 diabetes being the most common conditions)., Conclusions: Patients with bipolar disorder carry a substantial burden of general medical conditions, related to age and duration of illness. These results suggest that the development and testing of specific interventions that target medical risk factors and medical burden in patients with bipolar disorder are urgently needed, especially early in the course of the illness, when patients appear to accumulate medical comorbidity at a rapid rate.

Background: To date, no cross-national RCT has addressed the mechanisms underlying the relative success of pharmacological and psychotherapeutic interventions for depression. A multi-site clinical trial that includes psychotherapy as one of the treatments presents numerous challenges related to cross-site consistency and communication., Purpose: This report describes how those challenges were met in the study "Depression: The Search for Treatment Relevant Phenotypes'', being carried out at the University of Pittsburgh and the University of Pisa, Italy., Methods: Implementing the study required the investigators to address methodological and practical challenges related to the different requirements of the two Institutional Review Boards (IRBs), psychotherapy training, independent evaluator training, patient recruitment, development of common tools for data entry, quality control and generation of weekly reports of patient progress as well as establishing a similar clinical and research framework in two countries with substantially different health care systems., Results: By having bilingual investigators and staff members who spent time at one another's sites, making use of frequent conference-call staff meetings and being flexible within the bounds of the sometimes contradictory requirements of the IRBs, the investigators were able to meet the human subjects protection requirements of both institutions, surmount language barriers to consistent therapist and evaluator training and develop common tools for study management. As a result, recruitment goals were met at both sites and retention rates were high. One instance of inconsistent implementation of the protocol was corrected within the first year., Limitations: This study was conducted in two Western cultures by researchers with long-standing collaboration. Our findings may not be generalizable to other countries or research settings., Conclusions: The implementation of a cross-national protocol and the adoption and maintenance of common procedures is possible when investigators are aware of the challenges this may present and are proactive in trying to address them.