Fish Oil Supplementation in Late-life Depression

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

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.

Study Overview

• Status: Completed
• Conditions: Late-Life Depression
• Intervention / Treatment: Dietary supplement: N-3 polyunsaturated fatty acids

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.

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 110
    • Chih-Chiang Chiu
  • Taipei, Taiwan
    • Department of Psychiatry, Cathay General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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。	Dietary supplement: 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.; Other Names: Fish oil
Placebo Comparator: Placebo; Participants in this arm were received three identical capsules per day. All capsules included olive oil.	Dietary supplement: 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.; Other Names: Fish oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	week 8, 16, 24, 32, 40, 48

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of cognitive function	Comparison of cognitive function at week 48 between two groups after adjustment for age, gender, education and baseline cognitive funciton	Week 48

Collaborators and Investigators

• Sponsor: Taipei City Psychiatric Center, Taiwan
• Collaborators: National Science Council, Taiwan
• Investigators: Principal Investigator: CHIH-CHIANG CHIU, M.D., Department of Psychiatry, Taipei City Psychiatric Center, Taipei City Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: November 4, 2010
• First Submitted That Met QC Criteria: November 4, 2010
• First Posted (Estimate): November 5, 2010

Study Record Updates

• Last Update Posted (Estimate): November 5, 2010
• Last Update Submitted That Met QC Criteria: November 4, 2010
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Keywords: cognition; late-life depression; recurrence of depression; N-3 polyunsaturated fatty acids
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: 95004-62-161