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Fish Oil Supplementation in Late-life Depression

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01235533
First Posted: November 5, 2010
Last Update Posted: November 5, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Science Council, Taiwan
Information provided by:
Taipei City Psychiatric Center, Taiwan
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01235533


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

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
First Submitted: November 4, 2010
First Posted: November 5, 2010
Last Update Posted: November 5, 2010
Last Verified: November 2010

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
Protective Agents
Physiological Effects of Drugs
Enzyme Inhibitors