The objective of this randomized, double-blind, placebo controlled study is to test the hypothesis that the addition of Riluzole would improve psychopathology in subjects with schizophrenia treated with Risperidone. 30 patients with chronic DSM-IV-diagnosed schizophrenia will receive Risperidone (2-6 mg/day) combined with either placebo (N=15) or 100 mg/day of Riluzole (N=15) 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:IRCT201107281556N26
Registration date:2011-07-30, 1390/05/08
Registration timing:prospective
Last update:
Update count:0
Registration date
2011-07-30, 1390/05/08
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
2011-09-23, 1390/07/01
Expected recruitment end date
2012-06-23, 1391/04/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Riluzole on negative symptoms in patients with chronic schizophrenia: a double blind and placebo controlled trial
Public title
Riluzole in the treatment of the negative symptoms of schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:1- Age between 18-50, 2- Diagnosis of Schizophrenia based on DSM IV 3- chronic Schizophrenia( the duration of the disorder> 2 years), Minimum Score of 60 on Positive and Negative Scale- Exclusion Criteria:1- Substance dependence,2- IQ <70,3-any other mental disorder on axis I, 4-Any serious medical or neurological problem ,5- receiving oral antipsychotic medications during the last week or receiving any depot antipsychotic medication during the last month,6- receiving ECT during the last 14 days,7- 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:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
Added at :
Secondary trial Id
Added at :
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Keshavarz Blvd
City
Tehran
Postal code
Approval date
2011-07-17, 1390/04/26
Ethics committee reference number
14037
Health conditions studied
1
Description of health condition studied
schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Change in the severity of negative symptoms
Timepoint
Baseline and weeks 2, 4, 6 and 8 after begining of treatment
Method of measurement
Positive and Negative Syndrome Scale (PANSS)
Secondary outcomes
1
Description
Change in other PANSS subscale scores
Timepoint
Weeks: 2, 4, 6 and 8
Method of measurement
Positive and Negative Syndrome Scale (PANSS)
Intervention groups
1
Description
Tablet Risperidone (2-6 mg/day) combined with 100 mg/day of Tablets Riluzole as intervention group for 8 weeks
Category
Treatment - Drugs
2
Description
Tablets Risperidone (2-6 mg/day) combined with Tablets 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
Prof. Shahin Akhondzadeh
Street address
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. Akbar Fotouhi
Street address
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
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 Karegar 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
Fax
Email
s.akhond@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)