Protocol summary

Summary
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
Method of measurement
Positive and Negative Syndrome Scale (PANSS)

Secondary outcomes

empty

Intervention groups

1

Description
Iranian clozapine (Tehran shimi company) 100 mg TDS for 3 months
Category
Treatment - Drugs

2

Description
leponex (manufactured by Novartis pharmaceutical company-Switzerland) 100 mg tid for 3 months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Bahar institute
Full name of responsible person
Dr. Farzin Rezaei
Street address
Baharan district
City
Sanandaj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Dr Ataollah Heydari
Street address
Deputy of research, Kurdistan university of Medical Sciences, Pasdaran Blvd, Sanandaj
City
Sanandaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kurdistan 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
Kurdistan University of Medical Sciences
Full name of responsible person
Dr Farzin Rezaei
Position
Assistant professor of psychiatry
Other areas of specialty/work
Street address
Qhods hospital, Pasdaran street, Sanandaj, Iran
City
Sanandaj
Postal code
Phone
+98 87 1666 0025
Fax
Email
farrezaei@muk.ac.ir; Farzin.Rezaie@uok.ac.ir ; frrezaie@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Dr Modabber Arasteh
Position
Assistant professor of psychiatry
Other areas of specialty/work
Street address
Qhods Hospital, Pasdaran blvd., Sanandaj, Iran
City
Sanandaj
Postal code
Phone
+98 87 1666 0025
Fax
Email
frrezaie@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Dr Farzin Rezaei
Position
Assistant professor of psychiatry
Other areas of specialty/work
Street address
Qhods Hospital, Pasdaran Blvd., Sanandaj, Iran
City
Sanandaj
Postal code
Phone
Fax
Email
frrezaie@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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