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Fish Oil Supplementation in Late-life Depression

NCT ID: NCT01235533

Last Updated: 2010-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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Patients with late-life depression were reported cognitive impairment, especially in information-processing speed, working memory, attention and episodic memory, even after depressive symptoms subside and some of them further progress to dementia in two to four years. Several epidemiological studies, fatty acid comparison studies, animal studies, and clinical trials found that omega-3 polyunsaturated fatty acids (PUFAs) were significantly associated with the major depression, cognitive decline in general population and Alzheimer's disease. Until now, there is no study investigating the effects of n-3 PUFAs on depressive symptoms and cognition in patients with late-life depression. Thus, the aims of this study were 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.

Conditions

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Late-Life Depression

Keywords

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late-life depression recurrence of depression cognition N-3 polyunsaturated fatty acids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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N-3 fatty acids

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。

Group Type EXPERIMENTAL

N-3 polyunsaturated fatty acids

Intervention Type DIETARY_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.

Placebo

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

Group Type PLACEBO_COMPARATOR

N-3 polyunsaturated fatty acids

Intervention Type DIETARY_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.

Interventions

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N-3 polyunsaturated fatty acids

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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Fish oil

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role collaborator

Taipei City Psychiatric Center, Taiwan

OTHER

Sponsor Role lead

Responsible Party

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Taipei City Psychiatric Center, Taipei City Hospital

Principal Investigators

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CHIH-CHIANG CHIU, M.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Chih-Chiang Chiu

Taipei, , Taiwan

Site Status

Department of Psychiatry, Cathay General Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type DERIVED
PMID: 34817851 (View on PubMed)

Other Identifiers

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95004-62-161

Identifier Type: -

Identifier Source: org_study_id