The objective of this randomized, double-blind, placebo controlled study is to assess the effects of zinc supplementation add on risperidone on positive and negative symptoms of schizophrenia. Thirty patients who are stratified according to age, gender and subtype of schizophrenia (paranoid and non-paranoid) will be assigned to treatment with 8 to 10 mg Risperidon plus three 220 mg capsules of zinc sulfate per day or the same dose of risperidone plus placebo for 6 weeks. Psychotic symptoms will be assessed by Positive and Negative Syndrome Checklist (PANSS) in week 0, 2, 4, and 6. Data are analyzed by repeated measure ANOVA, and Newman-Keuls with graph pad.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138801241457N3
Registration date:2011-06-07, 1390/03/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-06-07, 1390/03/17
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
Vice chancellor for research, Mazandaran University of Medical Sciences
Expected recruitment start date
2008-03-15, 1386/12/25
Expected recruitment end date
2009-07-16, 1388/04/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Zinc Sulfate add-on therapy compared to risperidone alone in schizophrenia: a double-blind, randomized, placebo-controlled clinical trial
Public title
Zinc Sulfate add-on therapy compared to risperidone alone in schizophrenia: a double-blind, randomized, placebo-controlled clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: DSM-IV-TR criteria for schizophrenia, PANSS score more than 80, no anti psychotic consumption or seven half-life, the drug was wash out
Exclusion criteria: other psychiatric disorders such as substance dependence and physical illnesses, such as liver and renal failure, cardiovascular diseases, allergic and immune system disorders etc.
Age
From 18 years old to 65 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
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee, Vice Chancellor of Research
Street address
moalem sq.
City
sari
Postal code
4817844718
Approval date
2007-03-12, 1385/12/21
Ethics committee reference number
86-84
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20.9
ICD-10 code description
Schizophrenia, unspecified
Primary outcomes
1
Description
Severity of symptoms
Timepoint
Baseline and 2nd, 4th, and 6th week
Method of measurement
Positive and Negative Syndrome Scale (PANSS)
Secondary outcomes
1
Description
The speed of risperidone antipsychotic effect
Timepoint
Baseline and 2nd, 4th, and 6th week
Method of measurement
Positive and Negative Syndrome Scale (PANSS)
Intervention groups
1
Description
Prescription of 8 to 10 mg oral risperidone plus three 220 mg oral capsules of zinc sulfate per day for 6 weeks
Category
Treatment - Drugs
2
Description
Prescription of 8 to 10 mg oral risperidone plus three 220 mg oral capsules of placebo per day for 6 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Zare Hospital
Full name of responsible person
Mehran Zarghami
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, Moallem Square
City
Sari
Grant name
86-84
Grant code / Reference number
86-84
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
Mehran Zarghami
Position
Professor
Other areas of specialty/work
Street address
Zare Hospital, Neka Road
City
Sari
Postal code
4815466848
Phone
+98 15 1226 3763
Fax
+98 15 1328 5109
Email
mzarghami@mazums.ac.ir; mehran.zarghami@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mehran Zarghami
Position
Professor
Other areas of specialty/work
Street address
Zare Hospital Neka Road
City
Sari
Postal code
4815466848
Phone
+98 15 1226 3763
Fax
+98 15 1328 5109
Email
mzarghami@mazums.ac.ir; mehran.zarghami@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mehran Zarghami
Position
professor
Other areas of specialty/work
Street address
Zare Hospital, Neka Road
City
Sari
Postal code
4815466848
Phone
+98 15 1226 3763
Fax
+98 15 1328 5109
Email
mzarghami@mazums.ac.ir; mehran.zarghami@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)