The objective of this randomized, double-blind, placebo controlled study is to test the hypothesis that the addition of spironolacton would improve psychopathology in subjects with schizophrenia
Design
randomized, double-blind, placebo controlled study
method of randomization: Random permuted Block
Sample size: 52
Trial phase: 3
Settings and conduct
The study will be conducted among patients attending Qods Psychiatric Hospital-Sanandaj. Patients with schizophrenia who have admitted in Qods Hospital will be included in the trial provided the inclusion criteria will be met,
Participants/Inclusion and exclusion criteria
Inclusion criteria:1-Diagnosis of Schizophrenia based on DSM-5 criteria; 2- Age between 18-55; 3-Chronic Schizophrenia- duration of the disorder more than 2 years; 4-Minimum score of 20 in negative sub score. 5-being stable on an antipsychotic for the last 2 months( 6 months for clozapin)
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 ECT during the last 2 months ; 6-Acute or chronic systemic diseases; 7- History of neurosurgery; 8- History of head trauma 9-allergy to spironolactone 10-receiving mood stabilizers 11.gynecomastia
Intervention groups
Intervention group:regular antipsychotic combined with 100mg/day spironolacton as intervention group for 8 weeks
Control group: regular antipsychotic plus placebo for 8 weeks
Main outcome variables
Severity of schizophrenia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091229002935N8
Registration date:2019-12-07, 1398/09/16
Registration timing:registered_while_recruiting
Last update:2019-12-07, 1398/09/16
Update count:0
Registration date
2019-12-07, 1398/09/16
Registrant information
Name
Farzin Rezaei
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 1356 1822
Email address
farrezaei@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-21, 1398/08/30
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Spironolacton as adjunctive treatment of symptoms in patients with schizophrenia: a double blind and placebo controlled trial
Public title
Spironolacton as adjunctive treatment of negative symptoms in patients with schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of Schizophrenia based on DSM-5 criteria
Age between 18-55 years old
Chronic Schizophrenia- duration of the disorder more than 2 years
Minimum score of 20 in negative sub score
being stable on antipsychotic for the last 2 months(6 months for clozapine)
Exclusion criteria:
Any serious medical or neurological problem
IQ less than 70.
Substance dependence during the last 6 months(except for nicotine and caffeine)
receiving ECT during the last 2 months
Acute or chronic systemic diseases
History of head trauma
exacerbation of symptoms(developing the active phase)
hypersensitivity to spironolacton
post-psychotic depression
gynecomastia
Age
From 18 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Participants allocated to intervention or control group via Random permuted blocks ( each block has four cases):
AABB, ABAB, BBAA, BABA
A:Intervention Group
B:Control Group
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants, clinicians and outcome evaluators will be blind regarding grouping and receiving placebo
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kurdistan University of Medical Sciences
Street address
No 1, Pasdaran Blvd.Kurdistan University of Medical Sciences, Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
1344666177
Approval date
2019-09-30, 1398/07/08
Ethics committee reference number
IR.MUK.REC.1398.144
Health conditions studied
1
Description of health condition studied
schizophrenia
ICD-10 code
F20.0
ICD-10 code description
Paranoid schizophrenia
Primary outcomes
1
Description
Severity of schizophrenia
Timepoint
Baseline and weeks 2-4-8 after beginning of treatment
Method of measurement
by Positive and Negative Symptoms Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Antipsychotic medication combined with 100 mg/day spironolacton as intervention group for 8 weeks
Category
Treatment - Drugs
2
Description
Control group: An antipsychotic combined with placebo as control group for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Qhods hospital- Sanandaj
Full name of responsible person
Dr Farzin Rezaei
Street address
Pasdaran Blvd- Qhods hospital - Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
1344666177
Phone
+98 87 3366 0025
Fax
+98 87 3366 1340
Email
farrezaei@muk.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Dr Ebrahim Ghaderi
Street address
Deputy of research, Kurdistan university of Medical Sciences, Pasdaran Blvd., Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
13446ـ66177
Phone
+98 87 3366 4653
Email
ebrahimghaderi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Farzin Rezaei
Position
Associate professor of psychiatry
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Qhods Hospital, Pasdaran street, Sanandaj, Iran
City
Sanandaj
Province
Kurdistan
Postal code
13446ـ66177
Phone
+98 87 1356 1822
Fax
+98 87 1666 1340
Email
farrezaei@muk.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Farzin Rezaei
Position
Associate professor of psychiatry
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Qhods Hospital, Pasdaran street, Sanandaj, Iran
City
Sanandaj
Province
Kurdistan
Postal code
13446ـ66177
Phone
+98 87 1356 1822
Fax
+98 87 1666 1340
Email
farrezaei@muk.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Farzin Rezaei
Position
Associate professor of psychiatry
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Qhods Hospital, Pasdaran street, Sanandaj, Iran
City
Sanandaj
Province
Kurdistan
Postal code
13446ـ66177
Phone
+98 87 1356 1822
Fax
+98 87 1666 1340
Email
farrezaei@muk.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All data will be distributed through final report
When the data will become available and for how long
from 2021 to 2026
To whom data/document is available
academic researchers
Under which criteria data/document could be used
by email
From where data/document is obtainable
Dr Farzin Rezaei
What processes are involved for a request to access data/document