1. Home
  2. Approved trials
  3. » فارسی

Comparing efficacy of Omega-3 and placebo in reducing beck depression score in HIV/AIDS patients

Protocol summary

Summary
The goal of this study is comparing efficacy of Omega-3 and placebo in reducing depression beck score in HIV/AIDS patients. This study is a randomized, double-blind clinical trial. One-hundred HIV positive patients, received antiretroviral therapy for at least one year and CD4 count≥350, with beck depression score≥16 will be included. Based on the block randomization method, included patients will be recruited in two equal groups. First group will be received soft gelatin Cap of omega-3, 1000 mg twice daily, for 8 weeks. The second group will be received placebo Cap, 1000 mg twice daily, for 8 weeks. Patients with history of other psychological disorders, major depression with recent suicidal attempt, history of drugs or alcohol abuse, sensitivity to omega-3, coagulation disorders or intake of anticoagulants and receiving any drugs that affect patients’ mood including anti-depressants will be excluded. The patients will be visited at time of entrance to the study and weeks 4 and 8. All patients will complete beck depression questionnaire at these times. Finally changes in the beck depression scores will be compared between the groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201410073449N17
Registration date: 2014-10-19, 1393/07/27
Registration timing: prospective

Last update:
Update count: 0
Registration date
2014-10-19, 1393/07/27
Registrant information
Name
Hossein Khalili
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 4715
Email address
khalilih@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research grant from Vice Chancellor for Research, Tehran University of Medical Sciences
Expected recruitment start date
2015-01-01, 1393/10/11
Expected recruitment end date
2017-01-01, 1395/10/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing efficacy of Omega-3 and placebo in reducing beck depression score in HIV/AIDS patients
Public title
Effect of Omega-3 on depression of HIV/AIDS patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: HIV positive patients with age between 18-65 years old, received antiretroviral therapy for at-least one years, CD4 count≥350 and Beck Depression Score (BDS)≥16. Exclusion criteria: HIV positive patients suffering from other psychological disorders, major depression with recent suicidal attempt, history of drugs or alcohol abuse, other concomitant severe medical diseases such as diabetes mellitus, intake of omega-3 during last 3 months, sensitivity to omega-3, coagulation disorders or intake of anticoagulants and receiving any drugs that affect patients’ mood including anti-depressants.
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Included patients will be assigned to the Omeag-3 or Placebo group based on the block randomization method. Randomization and distribution of the omega-3 or placebo will be done by the hospital pharmacy department and researchers, physicians and patients will be blinded regarding type of intervention (Omega-3 or placebo).

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Ghods Ave.
City
Tehran
Postal code
Approval date
2014-04-29, 1393/02/09
Ethics committee reference number
93-02-33-25813

Health conditions studied

1

Description of health condition studied
Depression
ICD-10 code
F32
ICD-10 code description
In typical mild, moderate, or severe depressive episodes, the patient suffers from lowering of mood, reduction of energy, and decrease in activity.

Primary outcomes

1

Description
Beck depression score
Timepoint
at baseline, weeks 4 and 8.
Method of measurement
Beck Depression Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Soft gelatin Cap of omega-3 (Cap 1000 mg, Zahravi Pharmaceutical Company, Tabriz, Iran), One Cap orally twice daily, for 8 weeks
Category
Treatment - Drugs

2

Description
Soft gelatin Cap of Placebo (Cap 1000mg, Zahravi Pharmaceutical Company, Tabriz, Iran), One Cap orally twice daily, for 8 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Hossein Khalili
Street address
Keshavarz Blvd.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Tehran University of Medical Sciences
Full name of responsible person
Masoud Yunesian
Street address
Ghods Ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Khalili
Position
Pharm. D
Other areas of specialty/work
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 6658 1598
Fax
Email
khalilih@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran university of Medical Sciences
Full name of responsible person
Hossein Khalili
Position
Pharm.D
Other areas of specialty/work
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 6658 1598
Fax
Email
khalilih@tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...