Effect of Buspirone added to Typical Antipsychotics on Positive and Negative symptoms in schizophrenia (a double blind, placebo controlled, randomized trial)
The object of this randomized, placebo controlled, double blind study is to test the hypothesis that the addition of Buspirone would improve psychopathology in subjects with Schizophrenia treated with Typical Antipsychotics. 50 patients with ages between 18-65 years who have no other medical or psychiatric conditions with chronic DSMIV-TR diagnosed Schizophrenia will receive Typical Antipsychotics combined with either placebo (N=25) or 30 mg/day of Buspirone (N=25) for 6 weeks. Efficacy will be defined as the change from baseline to endpoint in score on the Possitive and Negative Syndrom Scale(PANSS). Side effects will be also evaluated using checklist and Extrapyramidal Symptom Rating Scale. PANSS, SAS, GAF, MMSE Scales and side effects will be evaluated at baseline,2,4 and 6 weeks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106026691N1
Registration date:2012-09-17, 1391/06/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-09-17, 1391/06/27
Registrant information
Name
Fatemeh Sheikhmoonesi
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1328 5109
Email address
fmoonesi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences and Health Service
Expected recruitment start date
2012-04-03, 1391/01/15
Expected recruitment end date
2012-11-21, 1391/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Buspirone added to Typical Antipsychotics on Positive and Negative symptoms in schizophrenia (a double blind, placebo controlled, randomized trial)
Public title
Effect of Buspirone added to Typical Antipsychotics on Positive and Negative symptoms in schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Age between 18-65; Diagnosis of Schizophrenia based on DSMIV-TR; Chronic Schizophrenia(over 2 years); Ongoing treatment with Typical Antipsychotics.
Exclusion criteria:Allergic to Buspirone; Any chronic medical problem; Substance dependency; Any other Psychiatric Disorder in Axis I or II; Pregnancy or Breast feeding.
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Central building of Mazandaran University of Medical Scienses and Health Service, Daneshgah Blvd, Emam Square
City
Sari
Postal code
48154
Approval date
2011-05-31, 1390/03/10
Ethics committee reference number
1353
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 weeks 2-4-6 after begining of treatment
Method of measurement
Positive and Negative Syndrome Scale(PANSS)
Secondary outcomes
1
Description
Headache
Timepoint
Baseline and weeks 2,4,6 after begining of treatment
Method of measurement
Check list of adverse effects
2
Description
Nausea
Timepoint
Baseline and weeks 2-4-6 after begining of treatment
Method of measurement
Checklist of adverse effects
3
Description
Palpitation
Timepoint
Baseline and weeks 2-4-6 after begining of treatment
Method of measurement
Checklist of adverse effects
Intervention groups
1
Description
Typical Antipsychotics combined with Tablet Buspirone(30 mg/day) as intervention group for 6 weeks
Category
Treatment - Drugs
2
Description
Typical Antipsychotics combined with Tablets placebo as control group for 6 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Zare Psychiatry Hospital
Full name of responsible person
Dr Fatemeh Sheikhmoonesi
Street address
Psychiatric Department, Zare Psychiatry Hospital, Sari
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Ahmadali Enayati
Street address
Vice Chancellor for Research and Technology, Building N.2, Moallem Square, Moallem Street
City
Sari
Grant name
Grant code / Reference number
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 Fatemeh Sheikhmoonesi
Position
Assistant Prof. of Psychiatry, Psychiatrist
Other areas of specialty/work
Street address
Zare Psychiatry Hospital
City
Sari
Postal code
4815466848
Phone
+98 15 1328 5109
Fax
+98 15 1328 5109
Email
fmoonesi@mazums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Fatemeh Sheikhmoonesi
Position
Assistant Prof. of Psychiatry,Psychiatrist
Other areas of specialty/work
Street address
Zare Psychiatry Hospital
City
Sari
Postal code
4815466848
Phone
+98 15 1328 5109
Fax
+98 15 1328 5109
Email
fmoonesi@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Fatemeh Sheikhmoonesi
Position
Assistant Prof. of Psychiatry, Psychiatrist
Other areas of specialty/work
Street address
Zare Psychiatry Hospital
City
Sari
Postal code
4815466848
Phone
+98 15 1328 5109
Fax
+98 15 1328 5109
Email
fmoonesi@mazums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)