Fish Oil Supplementation in Late-life Depression

Late-Life Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01235533
• Other study ID #: 95004-62-161
• Status: Completed
• Phase: N/A
• First received: November 4, 2010
• Last updated: November 4, 2010
• Start date: May 2007
• Est. completion date: September 2010

Study information

• Verified date: November 2010
• Source: Taipei City Psychiatric Center, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan : Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Late-Life Depression

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Chih-Chiang Chiu	Taipei
Taiwan	Department of Psychiatry, Cathay General Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Taipei City Psychiatric Center, Taiwan	National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No