The aim of this study was comparing the effect of eicosapentaenoic acid and docosahexaenoic acid on the treatment of depression in 81 mild to moderately depressed outpatients referring to Bahman psychiatry clinic in Yazd (Iran). After obtaining informed consent, the patients were randomized into three groups receiving eicosapentaenoic acid, docosahexaenoic acid, or placebo supplements using table of random numbers. The patients received eicosapentaenoic acid 1 g/day, docosahexaenoic acid, 0.93 g/day, or coconut oil (as placebo), 1 g/day for 12 weeks in the winter of 2011. Our primary outcome was severity of depression which was assessed with clinical interview by a psychiatrist at the study entry and weeks 6 and 12 by using HRSD.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201010054873N1
Registration date:2011-07-03, 1390/04/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-07-03, 1390/04/12
Registrant information
Name
Seyede Elahe Shariaty Bafghi
Name of organization / entity
Yazd University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1522 4340
Email address
seyede.elahe.shariaty@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadughi University of Medical Sciences, Yazd, Iran
Expected recruitment start date
2010-08-16, 1389/05/25
Expected recruitment end date
2011-04-20, 1390/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of eicosapentaenoic acid and docosahexaenoic acid on the treatment of depression
Public title
Comparison of the effect of eicosapentaenoic acid and docosahexaenoic acid on the treatment of depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ages between 18-75 years; a Beck Depression Inventory II score of 10-28; a Hamilton Rating Scale for Depression score of 8-18; no changes in doses or types of antidepressant medications within 4 weeks prior to the study entry; diagnose of mild to moderate depression with structured clinical interview by a psychiatrist according to DSM-IV-TR criteria
Exclusion criteria: diagnosis of any co-morbid mental disorder other than depression, serious suicidal or homicidal thoughts; use of fish oil or omega, supplements within the last 6 months or having taken more than 3 servings per weeks of fish; any changes in doses or types of current antidepressant medications within study period or use of psychotropics, anticonvulsants, mood stabilizers, and anticoagulants; cupping or blood coagulation disorders, gastrointestinal absorption disorders, and eating disorders; allergy to sea foods or study drugs, and history of multiple adverse drug reactions; history of electroconvulsive therapy or severe medical disorders that may lead in depression including cardiovascular, hepatic, renal, respiratory, and endocrine diseases; smoking and drug or alcohol abuse; pregnancy or breastfeeding; serious adverse effects and incompliance to study protocol
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
81
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Sadughi University of Medical Sciences
Street address
Central Organization of Shahid Sadughi University of Medical Sciences, Bahonar Square, Yazd, Iran
City
Yazd
Postal code
8916978477
Approval date
2010-07-20, 1389/04/29
Ethics committee reference number
41170/1/17/پ
Health conditions studied
1
Description of health condition studied
Recurrent depressive disorder
ICD-10 code
F33
ICD-10 code description
Recurrent depressive disorder
Primary outcomes
1
Description
Severity of depression
Timepoint
Weeks 0, 6, and 12
Method of measurement
Hamilton Rating Scale for Depression
Secondary outcomes
1
Description
Remission
Timepoint
Week 12
Method of measurement
Hamilton Rating Scale for Depression
Intervention groups
1
Description
Control group: receiving coconut oil 1000 mg/day (2 oral capsules) for 12 weeks
Category
Placebo
2
Description
First intervention group: receiving eicosapentaenoic acid 1000 mg/day (2 oral capsules) for 12 weeks
Category
Treatment - Drugs
3
Description
Second intervention group: receiving docosahexaenoic acid 930 mg/day (2 oral capsules) for 12 weeks