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Fish Oil Supplementation in Late-life Depression

Primary Purpose

Late-Life Depression

Status

Completed

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

N-3 polyunsaturated fatty acids

About this trial

This is an interventional prevention trial for Late-Life Depression focused on measuring late-life depression, recurrence of depression, cognition, N-3 polyunsaturated fatty acids

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Chih-Chiang Chiu
Department of Psychiatry, Cathay General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

N-3 fatty acids

Placebo

Arm Description

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。

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

Outcomes

Primary Outcome Measures

Recurrence of depression

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

Secondary Outcome Measures

Change of cognitive function

Comparison of cognitive function at week 48 between two groups after adjustment for age, gender, education and baseline cognitive funciton

Full Information

NCT ID

NCT01235533

First Posted

November 4, 2010

Last Updated

November 4, 2010

Sponsor

Taipei City Psychiatric Center, Taiwan

Collaborators

National Science Council, Taiwan

1. Study Identification

Unique Protocol Identification Number

NCT01235533

Brief Title

Fish Oil Supplementation in Late-life Depression

Official Title

The Assessment for the Effects of Health Products on Depression and Cognitive Function:Fish Oil in Patients With Late-life Depression

Study Type

Interventional

2. Study Status

Record Verification Date

November 2010

Overall Recruitment Status

Completed

Study Start Date

May 2007 (undefined)

Primary Completion Date

September 2010 (Actual)

Study Completion Date

September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Taipei City Psychiatric Center, Taiwan

Collaborators

National Science Council, Taiwan

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Late-Life Depression

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

89 (Actual)

8. Arms, Groups, and Interventions

Arm Title

N-3 fatty acids

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

N-3 polyunsaturated fatty acids

Other Intervention Name(s)

Fish oil

Intervention Description

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.

Primary Outcome Measure Information:

Title

Recurrence of depression

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Change of cognitive function

Description

Comparison of cognitive function at week 48 between two groups after adjustment for age, gender, education and baseline cognitive funciton

Time Frame

Week 48

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

CHIH-CHIANG CHIU, M.D.

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chih-Chiang Chiu

City

Taipei

ZIP/Postal Code

110

Country

Taiwan

Facility Name

Department of Psychiatry, Cathay General Hospital

City

Taipei

Country

Taiwan

12. IPD Sharing Statement

Citations:

PubMed Identifier

34817851

Citation

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.

Results Reference

derived

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Fish Oil Supplementation in Late-life Depression

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