The Effect of Omega-3 Polyunsaturated Fatty Acids in the... | NCT01371383

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

NCT01371383

Sponsor

National Science and Technology Council, Taiwan

Status

Completed

Last Update Posted

Nov 13, 2023Actual

Enrollment

61Actual

Phase

Not Applicable

Conditions

Bipolar Disorder

Interventions

n-3 fatty acids
placebo

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2006

Primary Completion Date

May 31, 2014Actual

Completion Date

Aug 31, 2015Actual

First Submitted Date

Jun 7, 2011

First Submission Date that Met QC Criteria

Jun 9, 2011

First Posted Date

Jun 10, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 7, 2023

Last Update Posted Date

Nov 13, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kuan-Pin, China Medical University Hospital, National Science and Technology Council, TaiwanPrincipal Investigator

Lead Sponsor

National Science and Technology Council, TaiwanOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

61Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
n-3 fatty acids	Experimental	EPA 1680 mg/d + DHA 880 mg/d	Dietary Supplement: n-3 fatty acids
Placebo	Placebo Comparator	Soybean oil	Dietary Supplement: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
n-3 fatty acids	Dietary Supplement	EPA 1680 mg/d + DHA 880 mg/d	n-3 fatty acids

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kuan-Pin Su, MD PhD	China Medical University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
China Medical University Hospital		Taichung		404	Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34817851	Derived	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.

ID	Term
D000068105	Bipolar and Related Disorders
D019964	Mood Disorders
D001523	Mental Disorders

ID	Term
D004042	Dietary Fats, Unsaturated
D004041	Dietary Fats
D005223	Fats
D008055	Lipids