Fish Oil Supplementation in Late-life Depression

This study has been completed.
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by:
Taipei City Psychiatric Center, Taiwan
ClinicalTrials.gov Identifier:
NCT01235533
First received: November 4, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Late-Life Depression
Dietary Supplement: N-3 polyunsaturated fatty acids

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Assessment for the Effects of Health Products on Depression and Cognitive Function:Fish Oil in Patients With Late-life Depression

Resource links provided by NLM:


Further study details as provided by Taipei City Psychiatric Center, Taiwan:

Primary Outcome Measures:
  • Recurrence of depression [ Time Frame: week 8, 16, 24, 32, 40, 48 ] [ Designated as safety issue: Yes ]

    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


Secondary Outcome Measures:
  • Change of cognitive function [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    Comparison of cognitive function at week 48 between two groups after adjustment for age, gender, education and baseline cognitive funciton


Enrollment: 89
Study Start Date: May 2007
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Fish oil

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01235533

Locations
Taiwan
Department of Psychiatry, Cathay General Hospital
Taipei, Taiwan
Chih-Chiang Chiu
Taipei, Taiwan, 110
Sponsors and Collaborators
Taipei City Psychiatric Center, Taiwan
National Science Council, Taiwan
Investigators
Principal Investigator: CHIH-CHIANG CHIU, M.D. Department of Psychiatry, Taipei City Psychiatric Center, Taipei City Hospital
  More Information

No publications provided

Responsible Party: CHIH-CHIANG CHIU, Taipei City Psychiatric Center, Taipei City Hospital
ClinicalTrials.gov Identifier: NCT01235533     History of Changes
Other Study ID Numbers: 95004-62-161
Study First Received: November 4, 2010
Last Updated: November 4, 2010
Health Authority: Taiwan : Food and Drug Administration

Keywords provided by Taipei City Psychiatric Center, Taiwan:
late-life depression
recurrence of depression
cognition
N-3 polyunsaturated fatty acids

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
2-tert-butylhydroquinone
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 15, 2014