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Fish Oil Supplementation in Late-life Depression

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01235533
Enrollment
89
Registered
2010-11-05
Start date
2007-05-31
Completion date
2010-09-30
Last updated
2010-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Late-Life Depression

Keywords

late-life depression, recurrence of depression, cognition, N-3 polyunsaturated fatty acids

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.

Interventions

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.

Sponsors

National Science and Technology Council, Taiwan
CollaboratorOTHER_GOV
Taipei City Psychiatric Center, Taiwan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Recurrence of depressionweek 8, 16, 24, 32, 40, 48Definition 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

MeasureTime frameDescription
Change of cognitive functionWeek 48Comparison of cognitive function at week 48 between two groups after adjustment for age, gender, education and baseline cognitive funciton

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026