Minocycline as adjuvant therapy on negative symptoms in patients with chronic schizophrenia that are receiving resperidon: a double blind and placebo controlled randomized clinical trial
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 stable schizophrenia treated with Risperidone. 40 patients with chronic DSM-IV-diagnosed schizophrenia will receive Risperidone (6 mg/day) combined with either placebo (N=25) or 200 g/day of minocycline (N=25) for 8 weeks. Efficacy will be defined as the change from baseline to endpoint in score on the Positive and Negative Syndrome Scale (PANSS). Side effects will be also evaluated using checklist and Extra-pyramidal Symptoms Rating Scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202241556N34
Registration date:2012-03-01, 1390/12/11
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-03-01, 1390/12/11
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
2012-03-05, 1390/12/15
Expected recruitment end date
2012-07-22, 1391/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Minocycline as adjuvant therapy on negative symptoms in patients with chronic schizophrenia that are receiving resperidon: a double blind and placebo controlled randomized clinical trial
Public title
Minocycline in the treatment of schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Age between 18-50; Diagnosis of Schizophrenia based on DSM IV; chronic Schizophrenia( duration of the disorder>2 years); Stable on antipsychotics
Exclusion Criteria: Substance dependence; IQ <70; any other mental disorder on axis I; Any serious medical or neurological problem ; receiving oral antipsychotic medications during the last week or receiving any depot antipsychotic medication during the last month; receiving ECT during the last 14 days; hepatic disease
Age
From 18 years old to 50 years old
Gender
Both
Phase
2-3
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
2011-10-02, 1390/07/10
Ethics committee reference number
11921
Health conditions studied
1
Description of health condition studied
schizophrenia
ICD-10 code
F20
ICD-10 code description
schizophrenia
Primary outcomes
1
Description
Severity of schizophrenia
Timepoint
Baseline and weeks 2-4-6-8 after beginig of treatment
Method of measurement
Positive and Negative Syndrome Scale (PANSS)
Secondary outcomes
empty
Intervention groups
1
Description
Tablets Risperidone (6 mg/day) combined with 200mg/day Minocycline as intervention group for 8 weeks
Category
Treatment - Drugs
2
Description
Tablet Risperidone (6 mg/day) combined with placebo as control group for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh Hospital
Full name of responsible person
Dr. Shahin Akhondzadeh
Street address
South Kargar Sreeet
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Akbar Fotouhi
Street address
Keshvarz 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 21555412222
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 Karegar street
City
Tehran
Postal code
Phone
+98 21 5541 2222
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)