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Evaluation of the efficacy of atorvastatin in the treatment of major depressive disorder.

Protocol summary

Summary
This is a randomized, double-blind clinical trial to evaluate the efficacy of Atorvastatin in treating major depressive disorder. In this study 60 patients, referred to psychiatry ward of Farshchian Hospital will be enrolled in the study with consent inform ,who have been diagnosed as MDD based on DSM-IV TR and their age is between 18 to 50 years and have no known systemic disease and hypercholesterolemia and also have no history of illegal substance abuse. The patients will be divided into two groups based on randomized blocks. The case group will receive 40 mg citalopram along with atorvastatin 20 mg per day and the control group will receive 40 mg citalopram along with placebo. Prior to start the treatment, they will undergo ALT, AST, LDH, CPK, LDL, HDL, CHOL, and TG tests. Before the treatment and the intervals of 3, 6 and 12 weeks after the treatment, the patients’ depression wiil be assessed through Hamilton Depression Scale and finally the improvement rate of the both groups compared to each other.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201208261743N9
Registration date: 2012-09-09, 1391/06/19
Registration timing: prospective

Last update:
Update count: 0
Registration date
2012-09-09, 1391/06/19
Registrant information
Name
Mohammad Haghighi
Name of organization / entity
Research Center for Behavioral Disorders and Substance Abuse, Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 4184
Email address
haghighi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Sciences
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2013-05-22, 1392/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of atorvastatin in the treatment of major depressive disorder.
Public title
Effect of atorvastatin in in the treatment of major depressive
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: - Diagnosed as MDD according to DSM-IV TR - Age between 18 to 50 years - No other psychiatric disorders along with MDD - No other debilitating physical illness along with MDD - No hypercholesterolemia (Chol > 200) - No history of substance abuse during one past year - No known gastrointestinal disease - No abnormal hepatic enzymes (AST and ALT) - No abnormal LDH, 10-CPK Exclusion Criteria: - Severe gastrointestinal complication during the study - Increased CPK, LDH during the study - Increased hepatic enzymes during the study (AST, ALT)
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Hamadan University of Medical Sciences
Street address
Fahmideh str.Hamadan
City
Hamadan
Postal code
Approval date
2012-07-07, 1391/04/17
Ethics committee reference number
1276/9/35/16/پ/د

Health conditions studied

1

Description of health condition studied
Major Depressive Disorder
ICD-10 code
F32
ICD-10 code description
Depressive episode

Primary outcomes

1

Description
Severity of symptoms of Depression
Timepoint
Baseline and 3weeks, 6weeks ,12weeks after treatment
Method of measurement
Hamilton depression rating scale

Secondary outcomes

empty

Intervention groups

1

Description
administration of citalopram+placebo
Category
Treatment - Drugs

2

Description
administration of citalopram+atorvastatin
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Farshchian Hospital
Full name of responsible person
Mohammad Haghighi
Street address
Farshchian Hospital
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research center for behavioral disorders and substance abuse, Hamadan university of medical sciences
Full name of responsible person
Dr.Mohammad Ahmadpanah
Street address
honarestan Str
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research center for behavioral disorders and substance abuse, Hamadan 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
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
saeed khodakarami
Position
rezident of psychiatry
Other areas of specialty/work
Street address
farshchian hospital
City
Hamadan
Postal code
Phone
+98 81 1828 5015
Fax
Email
saeed_kh57@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Mohammad Haghighi
Position
Assistant Professor of Psychiatry
Other areas of specialty/work
Street address
Farshchian Hospital
City
Hamadan
Postal code
Phone
+98 81 1828 5015
Fax
Email
haghighi@umsha.ac.ir
Web page address

Person responsible for updating data

Contact

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
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