The objective of this randomized, double-blind, placebo controlled study was to assess the effects of D-penicillamine add on risperidone on positive and negative symptoms of schizophrenia. Thirty two in-patients with schizophrenia (paranoid and non-paranoid) are assigned to the intervention or control group. The patients in the intervention group receive 6 to 8 mg risperidon plus 1000 mg/day of D-penicillamine and 100mg/day piridoxine and in the control group receive the same dose of risperidone plus placebo and 100mg/day piridoxine for 6 weeks. Psychotic symptoms were assessed by Positive and Negative Syndrome Checklist (PANSS) weekly. Serum level of seroloplasmin was checked before and after the trial. Extra-pyramidal Side effects were also evaluated using Simpson-Angus Rating Scale weekly.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138801241457N4
Registration date:2010-11-02, 1389/08/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-11-02, 1389/08/11
Registrant information
Name
Mehran Zarghami
Name of organization / entity
Research Center for Psychiatry and Behavioral Sciences and Department of Psychiatry, Mazandaran Univ
Country
Iran (Islamic Republic of)
Phone
+98 15 1328 5659
Email address
mzarghami@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences and Health Services
Expected recruitment start date
2007-01-20, 1385/10/30
Expected recruitment end date
2008-01-20, 1386/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
D-Penicillamin Add-On Therapy Compared to Risperidone Alone in Schizophrenia: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial
Public title
D-Penicillamin Add-On Therapy Compared to Risperidone Alone in Schizophrenia: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: diagnosis of schizophrenia according to DSM-IV-TR with two physicians
Exclusion criteria: hepatic failure, renal failure, malignancies, pregnancy, drug addiction
Age
From 18 years old to 56 years old
Gender
Both
Phase
4
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
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran University of Medical Sciences
Street address
Vice Chancellor of Research-Mazandaran University of Medical Sciences, Moallem Square
City
Sari
Postal code
4817844718
Approval date
2007-10-09, 1386/07/17
Ethics committee reference number
87-88
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 symptoms
Timepoint
weekly
Method of measurement
PANSS
Secondary outcomes
1
Description
Faster response to risperidone and side effects
Timepoint
weekly
Method of measurement
PANSS, Liver Function Laboratory Tests, and checklist
Intervention groups
1
Description
Risperidone, 6-8 mg, orally, plus D-penicillamine, 1000 mg/day, and Piridoxine, 100 mg/day, for 6 weeks
Category
Treatment - Drugs
2
Description
Risperidone, 6-8 mg, orally, plus Placebo, 1000 mg/day, and Piridoxine, 100 mg/day, for 6 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Zare Hospital
Full name of responsible person
Dr. Mehdi Pourasghar
Street address
Zare Hospital, Neka Road
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Seyed Jalal Hoseini Mehr
Street address
Vice Chancellor of Research, Mazandaran University of Medical Sciences, Moallem Square
City
Sari
Grant name
10506
Grant code / Reference number
10506
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Mehdi Pourasghar
Position
Psychiatrist
Other areas of specialty/work
Street address
Psychiatry and Behavioral Sciences Research Center, Zare Hospital