The aim of this study was to investigate the role of allopurinol in the treatment of major depression is a double-blinded, 70 patients with major depression referred to Amir Kabir Hospital after diagnosis according to the clinical interview based on DSMV-TR randomly divided into two equal groups Both groups received 40 mg of citalopram for 6 weeks in addition to the 300 mg allopurinol daily citalopram treatment group and the control group will receive a placebo. At the end of the third week and sixth of the Hamilton depression will be reassessed. Also, the effects of allopurinol liver after 2 to 4 weeks of treatment, liver tests will be repeated again.
Inclusion criteria: age 18 to 65 years, diagnosed with major depression based on clinical interviews and diagnostic criteria for DSM V; normal blood levels of uric acid and liver enzymes (ALT, AST)
Exclusion criteria: Serious psychiatric disorders, personality disorders; Taking several drugs simultaneously; severe physical illness; Sensitivity to allopurinol
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201508277373N6
Registration date:2015-12-03, 1394/09/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-12-03, 1394/09/12
Registrant information
Name
Hamidreza Jamilian
Name of organization / entity
Arak University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1222 5758
Email address
jamilian.hr@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy for Research and Technology Arak University of Medical Sciences
Expected recruitment start date
2015-07-11, 1394/04/20
Expected recruitment end date
2016-07-10, 1395/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of allopurinol and placebo in reducing depressive symptoms in patients with major depressive disorder
Public title
Comparison of the effectiveness of allopurinol and placebo in reducing depressive symptoms in patients with major depressive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 18 to 65 years, diagnosed with major depression based on clinical interviews and diagnostic criteria for DSM V; normal blood levels of uric acid and liver enzymes (ALT, AST)
Exclusion criteria: Serious psychiatric disorders, personality disorders; Taking several drugs simultaneously; severe physical illness; Sensitivity to allopurinol
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:
70
Randomization (investigator's opinion)
N/A
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
Arak University of Medical Sceinces
Street address
Alamolhoda St., Maskan St., Arak
City
Arak
Postal code
Approval date
2015-07-11, 1394/04/20
Ethics committee reference number
IR.ARAKMU.REC.1394.68
Health conditions studied
1
Description of health condition studied
Major depression
ICD-10 code
F32.0
ICD-10 code description
Mild depressive episode
2
Description of health condition studied
Major depression
ICD-10 code
F32.1
ICD-10 code description
Moderate depressive episode
Primary outcomes
1
Description
Hamilton Square
Timepoint
Before the intervention, 4 to 6 weeks, end of study
Method of measurement
Hamilton questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group clinical citalopram 40 mg for 6 weeks plus allopurinol 300 mg daily receive.
Category
Treatment - Drugs
2
Description
Clinical citalopram 40 mg daily for 6 weeks plus a control group that received placebo.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Kabir Hospital and Emam Reza Clinical
Full name of responsible person
Dr. Jamilian Hamidreza
Street address
Amir Kabir Hospital, Rahahan St., Arak
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sceinces
Full name of responsible person
Dr. Rafiee Mohammad
Street address
School of Medicine, Alamolhoda St., Maskan St., Arak
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?