The aim of this study is to evaluate the effectiveness of second-generation antipsychotics addition of buspirone to treat the negative symptoms of schizophrenia patients.40 patients with schizophrenia are divided randomly into two treatment groups, each one 20 patients .Present study is double blinded with Trial phase 2 and 3. Patients with schizophrenia and a score more than 15 subtypes in negative symptoms are in the study and if they had a history of sensitivity to antipsychotics or buspirone or they are bipolar disorders, then excluded. The intervention group received 40 mg buspirone and second generation antipsychotic risperidone equivalent of 2-6 mg of risperidon and the case group receive 40 mg placebo with the second generation of 2-6 mg of risperidone.Patients will be evaluated at baseline and 3th and 6th week about negative symptoms of schizophrenia and the general scale PANSS. This test have been designed to evaluate the dimension and phenomenological aspects of schizophrenia.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017010431626N2
Registration date:2017-03-21, 1396/01/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-03-21, 1396/01/01
Registrant information
Name
Hatam Boostani
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3038
Email address
tabibi.y@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of added buspiron to atypical antipsychotic drugs in the treatment of negative symptoms in patients with schizophrenia
Public title
The effect of added buspiron to atypical antipsychotic drugs in the treatment of negative symptoms in patients with schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Age between 18 and 65 years old; Having schizophrenia according to DSM-VI-TR criteria; Bold negative symptoms( PANSS negative symptom sub-scale score more than 15); Disease duration of more than six months
Exclusion criteria: Bipolar disorders; Depression and other psychiatric disorders; Chronic medical conditions (liver, kidney and heart); A history of sensitivity to antipsychotics or buspirone; A history of failure to respond to treatment with adequate doses of antipsychotic medication; History of seizures; Pregnancy; Breastfeeding; Any disruption in the electrocardiogram; Simultaneous treatment with other drugs and active suicidal thoughts
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:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization was done by random number table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd, Ahvaz
City
Ahvaz
Postal code
Approval date
2016-07-02, 1395/04/12
Ethics committee reference number
IR.AJUMS.REC.1395.199
Health conditions studied
1
Description of health condition studied
schizophrenia
ICD-10 code
ّF20
ICD-10 code description
schizophrenia
Primary outcomes
1
Description
Negative symptoms
Timepoint
Before intervention, Three and six weeks after intervention
Method of measurement
PANSS questioner
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients receive 40 mg buspirone and the second generation antipsychotic equivalent of 2-6 mg of risperidon.
Category
Treatment - Drugs
2
Description
Control group: patients with schizophrenia receive 40mg placebo with the second generation of 2-6 mg of risperidone. Placebo pill will be like buspirone about the shape, color, smell and size.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Golestan hospital
Full name of responsible person
Hatam Boostani
Street address
Ahvaz Golestan hospital, Golestan Blvd, Ahvaz
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Hatam Boostani
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd, Ahvaz
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Hatam Boostani
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Psychiatry, Golestan hospital, Golestan Blvd, Ahvaz
City
Ahvaz
Postal code
Phone
+98 616133743038
Fax
Email
boostani-h@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Hata, Boostani
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Psychiatry,Golestan Hospital,Golestan Blvd,Ahvaz
City
Ahvaz
Postal code
Phone
+98 616133743038
Fax
Email
boostani_h@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Naghme Malek poor
Position
Assistant
Other areas of specialty/work
Street address
Ahvaz Golestan hospital, Golestan Blvd, Ahvaz
City
Ahvaz
Postal code
Phone
+98 616133743038
Fax
Email
n-malekpoor24@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)