The objective of this randomized, double-blind, placebo controlled study is to test the hypothesis that the addition of Minocycline would improve psychopathology in subjects with OCD treated with fluvoxamine. 50 patients with OCD will receive fluvoxamine (100 mg/day) combined with either placebo (N=25) or 200 mg/dayMinocycline (N=25) for 10 weeks. Patients will be assessed by a psychiatrist at baseline and after 2, 4 ,6,8 and 10 weeks after the medication started. OCD severity will be assessed by b the Yale-Brown obsessive compulsive scale(Y-B ocs)
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201501031556N70
Registration date:2015-01-04, 1393/10/14
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-01-04, 1393/10/14
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2015-01-21, 1393/11/01
Expected recruitment end date
2016-01-20, 1394/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Minocycline in the treatment of mild to moderate OCD: a randomized and double blinid trial
Public title
Minocycline in the treatment OCD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: 1-Age between 18-60 years old; 2-Diagnosis of OCD based on DSM 5; 3- Minimum Score of 21 on YALE-BROWN Obsessive-Compulsive Scale. Exclusion Criteria:1- Substance dependence; 2- IQ <70; 3-Any other mental disorder; 4-Any serious cardiac, renal or hepatic disease; 5- receiving psychotropic medications during the last 6 weeks; 6- pregnancy or breast feeding; 7-suicidal thoughts.
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Ethics Committee of Tehran University of Medical Sciences
Street address
Keshvarz Blvd
City
Tehran
Postal code
Approval date
2014-12-22, 1393/10/01
Ethics committee reference number
27224-30-03-90
Health conditions studied
1
Description of health condition studied
Obsessive-compulsive disorder
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder
Primary outcomes
1
Description
Severity of symptoms of OCD
Timepoint
Baseline and weeks 2-4-8-10 after beginig of treatment
Method of measurement
Y_BOCS
Secondary outcomes
empty
Intervention groups
1
Description
Fluvoxamine 100 mg/day + placebo for 10 weeks as control group
Category
Placebo
2
Description
Fluvoxamine 100 mg/day+ Minocycline 200 mg/day for 10 weeks as intervention group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh Hospital
Full name of responsible person
Prof. Shahin Akhondzadeh
Street address
Roozbeh Hospital, South Kargar Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Masoud Yunesian
Street address
Tehran University of Medical Sciences, Keshavarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Other areas of specialty/work
Street address
Roozbeh Hospital, South Kargar Street
City
Tehran
Postal code
Phone
+98 21 5541 2222
Fax
Email
s.akhond@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Other areas of specialty/work
Street address
Roozbeh Hospital, South Kargar Street
City
Tehran
Postal code
Phone
+98 21 5541 2222
Fax
Email
s.akhond@sina.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
Prof. Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Other areas of specialty/work
Street address
Roozbeh Hospital, South Kargar Street
City
Tehran
Postal code
Phone
+98 21 5541 2222
Fax
Email
s.akhond@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)