Protocol summary
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Study aim
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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
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Design
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Randomized, double-blind, placebo controlled study
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Settings and conduct
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The study will be conducted among patients attending Roozbeh Hospital-Tehran
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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Tablet Risperidone (6 mg/day) combined with 100mg/day Spironolactone as intervention group for 8 weeks
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Main outcome variables
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Severity of schizophrenia
General information
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Reason for update
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just to correct a thypo. Indeed, in the approved proposal was 100 mg/day
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20090117001556N120
Registration date:
2019-10-12, 1398/07/20
Registration timing:
prospective
Last update:
2020-09-07, 1399/06/17
Update count:
1
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Registration date
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2019-10-12, 1398/07/20
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-10-22, 1398/07/30
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Expected recruitment end date
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2021-10-22, 1400/07/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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Effect of Spirinolactone in treatment of Schizophrenia
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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 19 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
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Age
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From 18 years old to 50 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Outcome assessor
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Sample size
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Target sample size:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Random blocks ( each block has four cases)
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The participants, clinicians and outcome evaluators will be blind regarding grouping
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-10-03, 1398/07/11
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Ethics committee reference number
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IR.TUMS.VCR.REC.1398.540
Health conditions studied
1
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Description of health condition studied
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Schizophrenia
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ICD-10 code
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F20
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ICD-10 code description
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Schizophrenia
Primary outcomes
1
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Description
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Severity of schizophrenia
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Timepoint
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Baseline and weeks 2- 4- 8 after beginning of treatment
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Method of measurement
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by Positive and Negative Symptoms Scale
Secondary outcomes
1
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Description
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cognitive symptoms
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Timepoint
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Baseline and weeks 2- 4- 8 after beginning of treatment
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Method of measurement
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by MMSE
Intervention groups
1
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Description
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Intervention group: Tablet Risperidone (6 mg/day) combined with 100 mg/day Spironolactone as intervention group for 8 weeks
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Category
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Treatment - Drugs
2
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Description
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Control group: Tablet Risperidone (6 mg/day) combined with placebo as control group for 8 weeks
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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All data will be distributed through final report
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When the data will become available and for how long
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from 2021 to 2026
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To whom data/document is available
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academic researchers
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Under which criteria data/document could be used
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by email
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From where data/document is obtainable
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Prof Shahin Akhondzadeh
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What processes are involved for a request to access data/document
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s.akhond@sina.tums.ac.ir
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Comments
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