An interventional study of n-3 fatty acids and placebo in Bipolar Disorder, sponsored by National Science and Technology Council, Taiwan. Completed at 1 site in Taiwan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-11-13.
Sponsored by National Science and Technology Council, Taiwan · Not applicable, Interventional, and Prevention
The whole study will be divided into two major parts: (A) A 12-week, double-blind, randomized controlled, parallel n-3 fatty acids adjunctive therapy study in 30 bipolar disorder patients with mild to moderate depression. (B) A double-blind, randomized controlled, parallel n-3 fatty acid add-on prophylactic study in 31 patients with stable bipolar disorder.
Part of the study will be a 12-week parallel-group placebo-controlled double-blind randomized n-3 fatty acids add-on combination therapy trial. A total of 30 patients in the acute depression stage of bipolar disorder will be collected from outpatient clinics and randomly assigned to receive n-3 fatty acids or placebo. T-test (or Mann-Whitney U-Test) will be used to evaluate the differences in the severity of depressive and manic symptoms between the two groups across the study points. The second part of the study will be a 6-month add-on prophylactic trial with parallel-group, double-blind random allocation to n-3 fatty acids or placebo groups. A total of 31 patients with stable bipolar disorder recruited by newspaper advertisements will be recruited and randomly assigned to receive n-3 fatty acids or a placebo. Kaplan-Meier Survival analysis will be used to evaluate the differences in the recurrence rate of bipolar depression between the two groups. Also, t-test (or Mann-Whitney U-Test) will be used to evaluate the differences in the severity of depressive and manic symptoms between the two groups across the study points. The 2 separate studies will be conducted after approval from the Human Trials Committee.
1,637 studies on the registry are indexed under Bipolar Disorder; 258 are open to participants now.
This study's enrollment of 61 is close to the median of 63 across 1,245 interventional studies indexed under Bipolar Disorder.
Browse Bipolar Disorder studies →National Science and Technology Council, Taiwan is the lead sponsor of 6 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
EPA 1680 mg/d + DHA 880 mg/d
Dietary Supplement: n-3 fatty acids
Soybean oil
Dietary Supplement: placebo
EPA 1680 mg/d + DHA 880 mg/d
Soybean oil
Also known as: control
Changes in HRSD-21 scores
Differences in depression severity based on the Hamilton Rating Scale for Depression 21 (HRSD) across the study points.
Time frame: Weeks 0, 1, 2, 4, 6, 8, and 12
Differences in recurrence rate of bipolar depression
Differences in the rate of recurrence of bipolar disorder between the patients in the n-3 group and placebo group across the study points.
Time frame: From 0 to 6 months
Changes in Young Mania Rating Scale scores
Changes in Young Mania Rating Scale scores across the time points in the study
Time frame: Weeks 0, 1, 2, 4, 6, 8, and 12
The record gives a start of Jan 2006, a primary completion of May 2014 and a completion of Aug 2015. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Omega-3 fatty acid
National Science and Technology Council, Taiwan