Clinical trial NCT01235533: 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
Overall status: COMPLETED
Phase: NA
Conditions: Late-Life Depression
Keywords: late-life depression
recurrence of depression
cognition
N-3 polyunsaturated fatty acids
Lead sponsor: Taipei City Psychiatric Center, Taiwan
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2010-11-05
Enrollment: 89
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Recurrence of depression
timeFrame: week 8, 16, 24, 32, 40, 48
Secondary outcomes:
measure: Change of cognitive function
timeFrame: Week 48
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Chih-Chiang Chiu
city: Taipei
country: Taiwan
facility: Department of Psychiatry, Cathay General Hospital
Study officials:
affiliation: Department of Psychiatry, Taipei City Psychiatric Center, Taipei City Hospital
name: CHIH-CHIANG CHIU, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.