The objective of this randomized, double-blind, placebo controlled study is to test the hypothesis that the addition of Pregnenolone would improve psychopathology in subjects with schizophrenia treated with Risperidone. 50 female patients with chronic schizophrenia will receive Risperidone (6 mg/day) combined with either placebo (N=25) or 50 mg/day of Pregnenolone (N=25) for 8 weeks. Efficacy will be defined as the change from baseline to endpoint in score on the Positive and Negative Syndrome Scale (PANSS). Side effects will be also evaluated using checklist and Extra-pyramidal Symptoms Rating Scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201504211556N76
Registration date:2015-04-22, 1394/02/02
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-04-22, 1394/02/02
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Pregnenolone in the treatment of women with chronic schizophrenia: a double blind randomized trial
Public title
Pregnenolone in the treatment of women with chronic schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:1-women with Diagnosis of Schizophrenia based on DSM- 5 criteria; 2- Minimum Score of 60 on Positive and Negative Scale; 3- Age between 18-45; 4-Chronic Schizophrenia- duration of the disorder more than 2 years; 5-Minimum score of 20 in negative sub score. Exclusion criteria: 1-Any serious medical or neurological problem; 2- IQ less than 70; 3- Substance dependence during the last 6 months(except for nicotine and caffeine); 4-receiving oral antipsychotic medications during the last week or receiving any depot antipsychotic medication during the last month; 5-receiving ECT during the last 14 days ; 6-Hepatic and renal diseases; 7- History of thromboembolism ; 8- History of abnormal uterine bleeding, uterine or breast canser; 9-CVA; 10-Hormone replacement therapy; 11- Endocrine abnormality.
Age
From 18 years old to 45 years old
Gender
Female
Phase
4
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
Ethics Committee of Tehran University of Medical Sciences
Street address
Keshvarz Blvd
City
Tehran
Postal code
Approval date
2015-04-21, 1394/02/01
Ethics committee reference number
27746
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 2-4-8 after beginig of treatment
Method of measurement
Positive and Negative Syndrome Scale (PANSS)
Secondary outcomes
empty
Intervention groups
1
Description
Tablet Risperidone (6 mg/day) combined with 50 mg/day Pregnenolone as intervention group for 8 weeks
Category
Treatment - Drugs
2
Description
Tablet Risperidone (6 mg/day) combined with placebo as control group for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh Hospital
Full name of responsible person
Prof. Shahin Akhondzadeh
Street address
South Kregar street, Roozbeh Hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr masoud yunesian
Street address
Keshvarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Other areas of specialty/work
Street address
South Kargar street; Roozbeh Hospital
City
Tehran
Postal code
Phone
+98 21 5541 2222
Fax
Email
s.akhond@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Other areas of specialty/work
Street address
South Kargar Street; Roozbeh Hospital
City
Tehran
Postal code
Phone
+98 21 5541 2222
Fax
Email
s.akhond@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Other areas of specialty/work
Street address
South Karegar street; Roozbeh Hospital
City
Tehran
Postal code
Phone
+98 21 5541 2222
Fax
Email
s.akhond@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)