The purpose of this study is to assess the efficacy of ondansetron, a 5-HT3 receptor antagonist as an adjuvant agent in the treatment of chronic schizophrenia in particular for negative symptoms. This investigation is a 12-week, double blind study of parallel groups of patients with stable chronic schizophrenia. 44 patients are recruited from inpatient and outpatient departments. All participants meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia. To be eligible, patients are required to have treated with a stable dose of risperidone as their primary antipsychotic treatment for a minimum period of 8 weeks. The subjects are randomized to receive ondansetron (8 mg/day) or the placebo in addition to risperidone. Clinical psychopathology is assessed with Positive and Negative Syndrome Scale (PANSS). Cognition is measured by a Wechsler memory scale. Patients are assessed at baseline and after 4, and 8 weeks after the medication started. The PANSS scores and cognitive performance are used as the outcome measures.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112125280N7
Registration date:2012-04-17, 1391/01/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-04-17, 1391/01/29
Registrant information
Name
Raheleh Nejati
Name of organization / entity
Mashhad University of Medical Scinces, Ibn-e- Sina Psychiatric Hospital
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2540
Email address
nejatir2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad university of medical sciences
Expected recruitment start date
2011-03-21, 1390/01/01
Expected recruitment end date
2012-06-21, 1391/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Efficacy of ondansetron augmentation in negative sign of Schizophrenia
Public title
The Efficacy of ondansetron augmentation in negative sign of Schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients who have been treated with a stable dose of risperidone as their primary antipsychotic treatment for a minimum period of 8 weeks before entry into the study.
Exclusion criteria: Patients who had any medical diagnoses (including ECG conduction abnormalities, neurological disorder, or an active seizure) or were receiving medications that may have affected cognitive performance; Subjects who met the criteria for a DSM IV diagnosis of alcohol or substance abuse (other than for nicotine) within the last month or the criteria for DSM-IV alcohol or substance dependence (other than for nicotine) within the last 6 months; Pregnant or lactating women and those of reproductive age without adequate contraception; psychotropic medications were not allowed for the duration of the study: anticholinergics, sedating antihistaminic, antidepressants, mood stabilizers, or a second antipsychotic (as adjuvant therapy).
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
44
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 Mashhad University of Medical Scinces
Street address
Daneshgah Street, Ghoreishi Building
City
Mashhad
Postal code
Approval date
2010-06-15, 1389/03/25
Ethics committee reference number
89641
Health conditions studied
1
Description of health condition studied
schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
negative symptom
Timepoint
base line,weeks 4,8
Method of measurement
PANSS
Secondary outcomes
empty
Intervention groups
1
Description
Patients are required to have treated with a stable dose of risperidone (4-6mg/day) as their primary antipsychotic treatment and receive ondansetron (4-8 mg/day) for a minimum period of 8 weeks.
Category
Treatment - Drugs
2
Description
The control group receive the placebo in addition to risperidone (4-6 mg/day).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ibn-e-Sina psychiatric Hospital
Full name of responsible person
Faezeh Soltan Ahmadi
Street address
Ebne Sina psychiatric Hospital, Horre ameli avenue, Boo Ali square
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Marjan Ardakanian
Street address
Ghoreishi Building, Daneshgah Street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Ibn-e-sina Hospital, Mashhad University of Medical Sciences
Full name of responsible person
Dr Soozan Soluti
Position
resident
Other areas of specialty/work
Street address
Ibn-e-Sina psychiatric Hospital, Horre ameli avenue, Boo Ali square.
City
Mashhad
Postal code
Phone
+98 51 1879 7671
Fax
Email
solutis881@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ibn-e-Sina psychiatric Hospital, Mashhad University of Medical Sciences
Full name of responsible person
Dr Ali Akhondpour Manteghi
Position
Assistant Professor of Psychiatry
Other areas of specialty/work
Street address
Ibn-e-Sina psychiatric Hospital, Horre ameli avenue, Boo Ali square.
City
Mashhad
Postal code
Phone
+98 51 1711 2701
Fax
Email
manteghia@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ibn-e-Sina Hospital, Mashhad University of Medical Sciences
Full name of responsible person
Dr Soozan Soluti
Position
resident of psychiatry
Other areas of specialty/work
Street address
Ibn-e-Sina psychiatric Hospital, Horre ameli avenue, Boo Ali square.
City
Mashhad
Postal code
Phone
+98 51 1711 2701
Fax
Email
solutis881@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)