The objective of this randomized, double-blind, crossover study is to compare the efficacy of Iranian clozapine (manufactured by Tehran Chemie Pharmaceutical Company, Tehran, Iran) with leponex (manufactured by Novartis Pharmaceutical company- Switzerland) in subjects with schizophrenia. A total of 32 patients with chronic DSM-IV-diagnosed schizophrenia will be randomly assigned into two groups: group A will receive Iranian clozapine during first three months of the study and then will receive leponex for the other three months. Group B will firstly receive leponex and then will receive Iranian clozapine. The patients will be assessed by the Positive and Negative Syndrome Scale (PANSS) at the baseline and after 3 and 6 months after the study starts.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201010042935N4
Registration date:2010-10-28, 1389/08/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-10-28, 1389/08/06
Registrant information
Name
Farzin Rezaei
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 1356 1822
Email address
farrezaei@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Kurdistan University of Medical Sciences
Expected recruitment start date
2010-07-09, 1389/04/18
Expected recruitment end date
2011-01-08, 1389/10/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Iranian clozapine versus leponex in the treatment of the positive negative symptoms of schizophrenia: a double-blind randomized crossover trial.
Public title
Iranian clozapine versus leponex
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: diagnosis of Schizophrenia based on DSM IV, chronic Schizophrenia, resistant schizophrenia (no response to two different antipsychotics at past)
Exclusion Criteria: Substance dependence, any serious medical problem, development of agranulocytosis or seizure during treatment with clozapine
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kurdistan University of medical Sciences
Street address
Pasdaran Blvd
City
Sanandaj
Postal code
Approval date
2007-12-26, 1386/10/05
Ethics committee reference number
4643
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 3 and 6 months after beginnig of the treatmen