This is a double-blind, randomized, placebo-controlled clinical trial investigating the efficacy of minocycline for the treatment of schizophrenia. Sixthly patients with schizophrenia diagnosed using DSM-IV are randomly allocated in a 2:1 ratio to minocycline (200 mg/d) or placebo group. The patients will receive usual medication (typical and atypical antipsychotics). Therefore, minocycline is added to the medications. Alcohol dependency, pregnancy, and breast feeding are among the exclusive criteria. The duration of this study is 8 weeks. Clinical assessment will be occurred at baseline (Pre-intervention), week 2, week 4 and week 8.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108223930N12
Registration date:2011-11-08, 1390/08/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-11-08, 1390/08/17
Registrant information
Name
Ahmad Ghanizadeh
Name of organization / entity
Research Center for Psychiatry and Behavioral Sciences, Shiraz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1627 3070
Email address
ghanizad@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2011-09-23, 1390/07/01
Expected recruitment end date
2012-09-22, 1391/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of minocycline on the symptoms of schizophrenia, a randomized double blind controlled clinical trial
Public title
The effect of minocycline on the symptoms of schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Age of 18-65 years; both genders; diagnosed Schizophrenia using DSM-IV diagnostic criteria; capable and willing to provide written informed consent by the patients and/or caregiver.
Exclusion Criteria: Alcohol dependency; known or suspected pregnancy; women who are breastfeeding; and a known contraindication to minocycline treatment.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
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
Ethics committee of Shiraz University of Medical Sciences
Street address
Vice-chancellery of Research Affairs, Shiraz University of Medical sciences, Zand Street
City
Shiraz
Postal code
Approval date
2011-08-28, 1390/06/06
Ethics committee reference number
CT-90-5661
Health conditions studied
1
Description of health condition studied
schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Positive and Negative Syndrome Scale for schizophrenia
Timepoint
(Pre-intervention), 2nd week, 4th week and 8th week
Method of measurement
Interview
Secondary outcomes
empty
Intervention groups
1
Description
minocycline 200 mg/day
Category
Treatment - Drugs
2
Description
Placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Research Center for Psychiatry and Behavioral Sciences
Full name of responsible person
Motahhar Omrani
Street address
Hafez hospital, Chamran Street
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Gholamreza Hatam
Street address
Vice-chancellery of Research Affairs, Shiraz University of Medical sciences, Zand Street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical sciences
Full name of responsible person
Ahmad Ghanizadeh
Position
MD
Other areas of specialty/work
Street address
Hafez Hospital, Chamran street
City
Shiraz
Postal code
Phone
+98 71 1627 3070
Fax
Email
ghanizad@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)