Bipolar Disorder Research Study for Ages 12 and Older

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The Bipolar Disorder Center for Pennsylvanians aims to reduce significant differences in treatment results among Pennsylvanians with bipolar disorder, especially among youth, the elderly, rural residents, and African Americans who are less likely to receive adequate treatment, less likely to remain in treatment once identified, and less likely to have positive results if they remain in treatment. Half of the subjects receive either Guideline Intervention (GI) or Enhanced Clinical Intervention (ECI). ECI is a combination of information and support, such as education about bipolar disorder, the medications used to treat it, information about sleep practices and habits that affect quality of sleep, review of symptoms, medication side effects, and coping with side effects. It is predicted that Enhanced Clinical Intervention will be more effective in reducing the differences in results between those most at risk compared to mid-life Caucasians. The treatment study occurs at three sites across Pennsylvania and has emphasized the recruitment of African Americans, youth (ages 12 through 18), and adults over age 65.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kupfer, David J., M.D.
• Collaborators: Abbott; Bristol-Myers Squibb; Eli Lilly and Company; GlaxoSmithKline; Pfizer

Criteria

Inclusion Criteria:

• Age greater than or equal to 12 years.

• Able to give basic informed consent.

• Meets DSM-IV Criteria for Bipolar I, Bipolar II (if in the investigator's judgment long term treatment with a mood stabilizer is indicated), Bipolar NOS, or Schizoaffective Bipolar subtype.

• Because many adolescents have shorter periods of mania or hypomania than those required by the DSM-IV (at least 4 days for hypomania and 7 days for mania) adolescents are included who have a current episode of MDD and a history of episodes mania/hypomania that lasted for at least 2 days.

Exclusion Criteria:

• Unwilling or unable to comply with study requirements (e.g., complete study forms, attend scheduled evaluations).

• Not competent to provide informed consent in the opinion of the investigator.

• Mental retardation (IQ less than 70). Subjects suspected of mental retardation (e.g., chronic academic failure, multiple developmental delays) are evaluated using the Verbal Subtest of the Wechsler Intelligence test.

• Presence of schizophrenia, schizoaffective pervasive developmental disorder, current substance or alcohol dependence, and organic mental disorder. Substance dependence in early remission is not an exclusion criterion.

• Unstable medical illness or other medical contraindication to treatment with mood stabilizers, antidepressants or antipsychotic medications.

• Women who are planning to become pregnant, pregnant or breast-feeding.