The Effect of Omega-3 Polyunsaturated Fatty Acids in the Treatment and Prevention of Relapse of Bipolar Disorder

Not Applicable

Completed

• Conditions: Bipolar Disorder
• Interventions: Dietary Supplement: placebo; Dietary Supplement: n-3 fatty acids

• Registration Number: NCT01371383
• Lead Sponsor: National Science Council, Taiwan

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2006-01-01
• Study First Submitted: 2011-06-07
• Study First Submitted QC: 2011-06-09
• Study First Posted: 2011-06-10
• Primary Completion: 2014-05-31
• Study Completion: 2015-08-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-07
• Last Update Posted: 2023-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

1. DSM-IV criteria for bipolar disorder.
2. Age being age 18-65.
3. Capacity and willingness to give written informed consent.
4. Routine biochemical parameters within normal range.

Exclusion Criteria

1. Presence of any major medical illnesses.
2. Recent or past history of other DSM-IV axis I diagnoses such as psychotic disorders, organic mental disorders, substance abuse, substance dependence and anxiety disorder; acute psychotic state or strong suicidal attempts; and DSM-IV axis-II diagnoses, including borderline and antisocial personality disorder.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	Soybean oil
n-3 fatty acids	n-3 fatty acids	EPA 1680 mg/d + DHA 880 mg/d

Primary Outcome Measures

Name	Time	Method
Differences in recurrence rate of bipolar depression	From 0 to 6 months	Differences in the rate of recurrence of bipolar disorder between the patients in the n-3 group and placebo group across the study points.
Changes in HRSD-21 scores	Weeks 0, 1, 2, 4, 6, 8, and 12	Differences in depression severity based on the Hamilton Rating Scale for Depression 21 (HRSD) across the study points.

Secondary Outcome Measures

Name	Time	Method
Changes in Young Mania Rating Scale scores	Weeks 0, 1, 2, 4, 6, 8, and 12	Changes in Young Mania Rating Scale scores across the time points in the study

Trial Locations

Locations (1)

China Medical University Hospital; 🇨🇳 Taichung, Taiwan