Combination of estrogen and antipsychotics in the treatment of women with chronic schizophrenia: a double-blind, randomized and placebo-controlled clinical trial
This study designed to evaluate efficacy of conjugated estrogen in the treatment of patients with chronic schizophrenia. Participants in this study were 32 childbearing-aged women with chronic schizophrenia. These patients were hospitalized in an institute for chronically mentally ill patients. Participants were randomly divided into two groups: the first group (16 cases) received conjugated estrogen 0.625 mg/Day four weeks along with their previous antipsychotic regimen while the second group (16 cases) received adjunctive placebo plus antipsychotics. Positive and Negative Syndrome Scale (PANSS) used as measurement tool for assessment of psychopathology.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138901283739N1
Registration date:2010-05-29, 1389/03/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-05-29, 1389/03/08
Registrant information
Name
Fateme Ghaderi
Name of organization / entity
Yasuj University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1229 6827
Email address
ghaderifa@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Yasuj University of Medical Sciences
Expected recruitment start date
2006-09-23, 1385/07/01
Expected recruitment end date
2007-09-23, 1386/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Combination of estrogen and antipsychotics in the treatment of women with chronic schizophrenia: a double-blind, randomized and placebo-controlled clinical trial
Public title
Estrogen for schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: child-bearing age women with chronic schizophrenia, kept in Behravan institute, Yasuj
Exclusion criteria: pregnancy, lactation, concurrent hormonal treatment, abnormal uterus bleeding, positive history of deep vein thrombosis, any serious neurologic disorders
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
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
Ethics committee of Yasuj University of Medical Sciences
Street address
Jalil street, Yasuj, Iran
City
Yasuj
Postal code
75919-94799
Approval date
2006-02-01, 1384/11/12
Ethics committee reference number
84-11-6
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20, F21,
ICD-10 code description
Schizophrenia, schizotypal and delusional disorders
Primary outcomes
1
Description
Schizophrenia symptoms
Timepoint
4 weeks
Method of measurement
PANSS
Secondary outcomes
empty
Intervention groups
1
Description
conjugated estrogen 0.625 mg/Day for four weeks
Category
Treatment - Drugs
2
Description
Placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Behravan Rehabilitation Center
Full name of responsible person
Khodakaram Nikbakht
Street address
Besenjan
City
Yasuj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasuj University of Medical Sciences
Full name of responsible person
Dr. Moshfe Abdolali
Street address
Jalil st., Yasuj, Iran
City
Yasuj
Grant name
تحقیقات دانشگاهی
Grant code / Reference number
10506
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasuj 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
Yasuj University of Medical Sciences
Full name of responsible person
Ali Mohammadi
Position
Psychiatrist, Assistant Professor
Other areas of specialty/work
Street address
Jalil st., Yasuj, Iran
City
Yasuj
Postal code
75919-94799
Phone
+98 74 1223 0290
Fax
+98 74 1223 5153
Email
amohammadi@hotmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasuj University of Medical Sciences
Full name of responsible person
Ali Mohammadi
Position
Psychiatrist, Assistant Professor
Other areas of specialty/work
Street address
Jalil st., Yasuj, Iran
City
Yasuj
Postal code
75919-94799
Phone
+98 74 1223 0290
Fax
+98 74 1223 5153
Email
amohammadi@hotmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yasuj University of Medical Sciences
Full name of responsible person
Ali Mohammadi
Position
Psychiatrist, Assistant Professor
Other areas of specialty/work
Street address
Jalil st., Yasuj, Iran
City
Yasuj
Postal code
75919-94799
Phone
+98 74 1223 0290
Fax
+98 74 1223 5153
Email
amohammadi@hotmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)