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

National Science Council, Taiwan

Status

Completed

Conditions

Bipolar Disorder

Treatments

Dietary Supplement: n-3 fatty acids

Dietary Supplement: placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01371383

DOH94F044

Details and patient eligibility

About

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.

Full 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.

Enrollment

61 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.