Relapse Prevention for Bipolar Type-II Disorder
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|ClinicalTrials.gov Identifier: NCT00044616|
Recruitment Status : Completed
First Posted : September 5, 2002
Last Update Posted : October 6, 2015
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder Depression||Drug: Fluoxetine Drug: Lithium||Phase 4|
Bipolar II (BP II) disorder is characterized by a high recurrence of major depressive episodes (MDE), and it is associated with substantial illness and deaths. Unfortunately, relatively little attention has been given to treatment of BP II. Concern that patients may switch from depressed to manic states during treatment of MDE has impeded the development of effective treatments for BP II MDE.
BP II MDE patients are treated initially with fluoxetine for 10 weeks. Patients who recover from MDE are then randomized to receive a relapse-prevention treatment of fluoxetine, lithium, a combination of fluoxetine and lithium, or placebo for 1 year. Patients undergo clinical and laboratory evaluations, including physical examinations, bloodwork, thyroid function tests, electrocardiogram (ECG), urinalysis, and HAM-D, YMR, CGI-S, CGI-I, and adverse events scales.
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|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Relapse Prevention of Bipolar Type-II Disorder|
|Study Start Date :||February 2001|
|Actual Primary Completion Date :||January 2007|
|Actual Study Completion Date :||January 2007|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00044616
|United States, Pennsylvania|
|Depression Research Unit, Univ Penn|
|Philadelphia, Pennsylvania, United States, 19104|