Fish Oil Supplementation in Late-life Depression

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Late-Life Depression

Intervention / Treatment
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* Dietary Supplement: N-3 polyunsaturated fatty acids


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: N-3 fatty acids<br>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<br>* 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.<br>* Other names: Fish oil;|
| Placebo Comparator: Placebo<br>Participants in this arm were received three identical capsules per day. All capsules included olive oil. | Dietary Supplement: N-3 polyunsaturated fatty acids<br>* 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.<br>* Other names: Fish oil;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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late-life depression, recurrence of depression, cognition, N-3 polyunsaturated fatty acids