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

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01371383
• Other study ID #: DOH94F044
• Status: Completed
• Phase: N/A
• Start date: January 1, 2006
• Est. completion date: August 31, 2015

Study information

• Verified date: November 2023
• Source: National Science Council, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: August 31, 2015
• Est. primary completion date: May 31, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Dietary Supplement:
• n-3 fatty acids
EPA 1680 mg/d + DHA 880 mg/d
• placebo
Soybean oil

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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