The Effect of Omega-3 Polyunsaturated Fatty Acids in the Treatment and Prevention of Relapse of Bipolar Disorder
1 other identifier
interventional
61
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2006
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 7, 2011
CompletedFirst Posted
Study publicly available on registry
June 10, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2015
CompletedNovember 13, 2023
November 1, 2023
8.4 years
June 7, 2011
November 7, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Changes in Young Mania Rating Scale scores
Weeks 0, 1, 2, 4, 6, 8, and 12
Study Arms (2)
n-3 fatty acids
EXPERIMENTALEPA 1680 mg/d + DHA 880 mg/d
Placebo
PLACEBO COMPARATORSoybean oil
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
China Medical University Hospital
Taichung, 404, Taiwan
Related Publications (1)
Appleton KM, Voyias PD, Sallis HM, Dawson S, Ness AR, Churchill R, Perry R. Omega-3 fatty acids for depression in adults. Cochrane Database Syst Rev. 2021 Nov 24;11(11):CD004692. doi: 10.1002/14651858.CD004692.pub5.
PMID: 34817851DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kuan-Pin Su, MD PhD
China Medical University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- China Medical University Hospital
Study Record Dates
First Submitted
June 7, 2011
First Posted
June 10, 2011
Study Start
January 1, 2006
Primary Completion
May 31, 2014
Study Completion
August 31, 2015
Last Updated
November 13, 2023
Record last verified: 2023-11