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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Bipolar Disorder

Intervention / Treatment
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* Dietary Supplement: n-3 fatty acids
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: DSM-IV criteria for bipolar disorder. Age being age 18-65. Capacity and willingness to give written informed consent. Routine biochemical parameters within normal range. Exclusion Criteria: Presence of any major medical illnesses. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: n-3 fatty acids<br>EPA 1680 mg/d + DHA 880 mg/d | Dietary Supplement: n-3 fatty acids<br>* EPA 1680 mg/d + DHA 880 mg/d<br>|
| Placebo Comparator: Placebo<br>Soybean oil | Dietary Supplement: placebo<br>* Soybean oil<br>* Other names: control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in HRSD-21 scores | Differences in depression severity based on the Hamilton Rating Scale for Depression 21 (HRSD) across the study points. | 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. | From 0 to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Young Mania Rating Scale scores | Changes in Young Mania Rating Scale scores across the time points in the study | Weeks 0, 1, 2, 4, 6, 8, and 12 |