NCT01235533

Brief Summary

To investigate whether fish oil supplementation, compared to placebo (olive oil), could have better effects on depression course and cognitive function in older people with major depression.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 5, 2010

Completed
Last Updated

November 5, 2010

Status Verified

November 1, 2010

Enrollment Period

3.3 years

First QC Date

November 4, 2010

Last Update Submit

November 4, 2010

Conditions

Late-Life Depression

Keywords

late-life depressionrecurrence of depressioncognitionN-3 polyunsaturated fatty acids

Outcome Measures

Primary Outcomes (1)

  • Recurrence of depression

    Definition of recurrence of depression (between last visit and current visit): 1. Fulfilled diagnosis of major depressive episode according to DSM-IV-TR 2. Score of sucide subscale in 17-item Hamilton Depression Rating was 3 or over 3. Hospitalization due to depression

    week 8, 16, 24, 32, 40, 48

Secondary Outcomes (1)

  • Change of cognitive function

    Week 48

Study Arms (2)

N-3 fatty acids

EXPERIMENTAL

Participants in this arm were received three capsules of n-3 fatty acids. Each capsule included 600mg eicosapentanoic acid (20:5n-3), 400 mg of docosahexanoic acid (22:6n-3), tertiary-butylhydroquinone 0.2 mg/g and tocopherols 2 mg/g。

Dietary Supplement: N-3 polyunsaturated fatty acids

Placebo

PLACEBO COMPARATOR

Participants in this arm were received three identical capsules per day. All capsules included olive oil.

Dietary Supplement: N-3 polyunsaturated fatty acids

Interventions

N-3 polyunsaturated fatty acidsDIETARY_SUPPLEMENT

Three capsules per day. Each capsule included 600mg eicosapentanoic acid (20:5n-3), 400 mg of docosahexanoic acid (22:6n-3), tertiary-butylhydroquinone 0.2 mg/g and tocopherols 2 mg/g.

Also known as: Fish oil
N-3 fatty acidsPlacebo

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • An age range of 60 years old or over;
  • A previous diagnosis of major depressive disorder according to the Chinese version of Structured Clinical Interview for DSM IV-TR Axis-I Disorder;
  • Depressive symptoms were stable for at least three consecutive weeks and the 17-item Hamilton Depression Rating Scale score less or equal to 10.
  • Capacity to provide informed consent.

You may not qualify if:

  • People with severe or acute medical illness ( such as metastatic cancer, brain tumor, decompensated cardiac, hepatic, or renal failure, or myocardial infarction or stroke) within the 3 months preceding the study.
  • Those who had neurological disorders involving central nervous system, such as delirium, Parkinson's disease, aphasia or multiple sclerosis)
  • Prominent cognitive impairment, defined as the Chinese version of Mini-Mental State examination score less than 17.
  • People with alcoholism, defined by a score of 8 or higher in male and of 6 or higher in female on the Chinese version of the Alcohol Use Disorders Identification Test (AUDIT) questionnaire.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chih-Chiang Chiu

Taipei, 110, Taiwan

Location

Department of Psychiatry, Cathay General Hospital

Taipei, Taiwan

Location

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

Interventions

Fatty Acids, Omega-3Fish Oils

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsOils

Study Officials

  • CHIH-CHIANG CHIU, M.D.

    Department of Psychiatry, Taipei City Psychiatric Center, Taipei City Hospital

    PRINCIPAL INVESTIGATOR

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

Study Record Dates

First Submitted

November 4, 2010

First Posted

November 5, 2010

Study Start

May 1, 2007

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

November 5, 2010

Record last verified: 2010-11

Locations

TW(2)