Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2025-12-24 @ 6:29 PM
NCT ID:
NCT00010868
Brief Summary:
This is a 12 month study of omega-3 fatty acids in bipolar disorder. This study will be a 12-month, parallel group, double-blind comparison of the prophylactic efficacy of omega-3 fatty acids vs. placebo in 120 bipolar I patients. All subjects entering the primary prophylactic study will be euthymic or have only subsyndromal mood symptoms for at least 4 weeks. In addition, their concomitant medication (only lithium, divalproex, or no medication will be permitted) will also be stable and at accepted therapeutic levels for at least 4 weeks. An 8-week lead-in phase will be available to subjects who do not meet the current symptom and concomitant medication inclusion criteria (however, subjects must meet all of the other inclusion/exclusion criteria): 1. 4 weeks of euthymic or subsyndromal mood. 2. Subjects who are not already receiving lithium or divalproex. 3. Subjects receiving other psychotropic medications.
Study:
NCT00010868
Study Brief:
Protocol Section:
NCT00010868