Effect of Spirinolactone as an Adjuvant Therapy on Improvement of Negative Signe and Cognitive Symptoms in Schizophrenic Patients ; A randomized, double-blind clinical trial with placebo control
The objective of this randomized, double-blind, placebo controlled study is to test the hypothesis that the addition of Spironolactone would improve psychopathology in subjects with schizophrenia treated with Risperidone
Design
Randomized, double-blind, placebo controlled study
Settings and conduct
The study will be conducted among patients attending Roozbeh Hospital-Tehran
Participants/Inclusion and exclusion criteria
Inclusion criteria:1-Diagnosis of Schizophrenia based on DSM-5 criteria; 2- Age between 18-50; 3-Chronic Schizophrenia- duration of the disorder more than 2 years; 4-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- meeting the criteria of majoedepressive disorder 5-receiving ECT during the last 2 weeks; 6.concurrent consumption of alcohol 7- History of cardiac surgery; 8- receiving oral antipsychotic during the last week or depot antipsychotic during the last month 9.suicidality 10. hyperkalemia
Intervention groups
Tablet Risperidone (6 mg/day) combined with 25mg/day Spironolactone as intervention group for 8 weeks
Main outcome variables
Severity of schizophrenia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090117001556N120
Registration date:2019-10-12, 1398/07/20
Registration timing:prospective
Last update:2019-10-12, 1398/07/20
Update count:1
Registration date
2019-10-12, 1398/07/20
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
Expected recruitment start date
2019-10-22, 1398/07/30
Expected recruitment end date
2021-10-22, 1400/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Spirinolactone as an Adjuvant Therapy on Improvement of Negative Signe and Cognitive Symptoms in Schizophrenic Patients ; A randomized, double-blind clinical trial with placebo control
Public title
Effect of Spirinolactone in treatment of Schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of Schizophrenia based on DSM-5 criteria
Age between 18-50
Chronic Schizophrenia- duration of the disorder more than 2 years
Minimum score of 20 in negative sub score
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 weeks
Serum potassium more than 5 meq/L
History of cardiosurgery
Receiving oral antipsychotics during the last week or long-standing antipsychotic during the last month
Meeting the criteria of major depressive disorder
Suicidality
Concurrent consumption of alcohol
Pregnant or lactating women
Receiving Pentoxifylline
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Random blocks ( each block has four cases)
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants, clinicians and outcome evaluators will be blind regarding grouping
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Keshavarz Blv
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2019-10-03, 1398/07/11
Ethics committee reference number
IR.TUMS.VCR.REC.1398.540
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 beginning of treatment
Method of measurement
by Positive and Negative Symptoms Scale
Secondary outcomes
1
Description
cognitive symptoms
Timepoint
Baseline and weeks 2- 4- 8 after beginning of treatment
Method of measurement
by MMSE
Intervention groups
1
Description
Intervention group: Tablet Risperidone (6 mg/day) combined with 25 mg/day Spironolactone as intervention group for 8 weeks
Category
Treatment - Drugs
2
Description
Control group: 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 Psychiatry Hospital
Full name of responsible person
Dr. Sara Jafari
Street address
Roozbeh Hospital
City
Tehran
Province
Kurdistan
Postal code
1333715914
Phone
+98 21 5541 2222
Email
s.akhond@sina.tums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Ali Sahraian
Street address
Tehran University of Medical Sciences, Keshavarz Blv
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8898 7381
Email
Msahrai@tums.ac.ir
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
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
Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Psychiatrics
Street address
Roozbeh Hospital, South Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Fax
+98 21 5541 9113
Email
s.akhond@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Psychiatrics
Street address
Roozbeh Hospital, South Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Fax
+98 21 5541 9113
Email
s.akhond@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Psychiatrics
Street address
Roozbeh Hospital, South Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Fax
+98 21 5541 9113
Email
s.akhond@sina.tums.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
Prof Shahin Akhondzadeh
What processes are involved for a request to access data/document