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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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History
# Registration date Revision Id
2 2020-09-07, 1399/06/17 149989
1 2019-10-12, 1398/07/20 107270
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  • Protocol summary

    Tablet Risperidone (6 mg/day) combined with 25mg/day Spironolactone as intervention group for 8 weeks
    Tablet Risperidone (6 mg/day) combined with 100mg/day Spironolactone as intervention group for 8 weeks
    قرص ريسپريدون 6 ميلي گرم در روز +کپسول اسپیرونولاکتون 25 میلیگرم در روز بمدت 8 هفته
    قرص ريسپريدون 6 ميلي گرم در روز +کپسول اسپیرونولاکتون 100 میلیگرم در روز بمدت 8 هفته

  • General information

    empty
    just to correct a thypo. Indeed, in the approved proposal was 100 mg/day
    empty
    اصلاح یک اشتباه تایپی در پروپوزال مصوب 100 میلی گرم بوده است
    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
    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
    داشتن معيار تشخيصي DSM –5 براي اسكيزوفرنيا
    سن بین 18 تا-50 سال
    حداقل بيش از دو سال از شروع بيماري گذشته باشد
    حداقل نمره بیمار در خرده مقیاس علایم منفی 20 باشد
    داشتن معيار تشخيصي DSM –5 براي اسكيزوفرنيا
    سن بین 18 تا-50 سال
    حداقل بيش از دو سال از شروع بيماري گذشته باشد
    حداقل نمره بیمار در خرده مقیاس علایم منفی 19 باشد

  • Intervention groups

    #1
    Intervention group: Tablet Risperidone (6 mg/day) combined with 25 mg/day Spironolactone as intervention group for 8 weeks
    Intervention group: Tablet Risperidone (6 mg/day) combined with 100 mg/day Spironolactone as intervention group for 8 weeks
    گروه مداخله: قرص ريسپريدون 6 ميلي گرم در روز +کپسول اسپیرونولاکتون 25 میلیگرم در روز بمدت 8 هفته
    گروه مداخله: قرص ريسپريدون 6 ميلي گرم در روز +کپسول اسپیرونولاکتون 100 میلیگرم در روز بمدت 8 هفته

  • Recruitment centers

    #1
    Name of recruitment center - English: Roozbeh Psychiatry Hospital
    Name of recruitment center - Persian: بيمارستان روزبه
    Full name of responsible person - English: Dr. Sara Jafari
    Full name of responsible person - Persian: دكتر شاهین آخوندزاده
    Street address - English: Roozbeh Hospital
    Street address - Persian: بيمارستان روزبه
    City - English: Tehran
    City - Persian: تهران
    Province: Kurdistan
    Country: Iran (Islamic Republic of)
    Postal code: 1333715914
    Phone: +98 21 5541 2222
    Fax:
    Email: s.akhond@sina.tums.ac.ir
    Web page address:
    Name of recruitment center - English: Roozbeh Psychiatry Hospital
    Name of recruitment center - Persian: بيمارستان روزبه
    Full name of responsible person - English: Dr. ُShahin Akhondzadeh
    Full name of responsible person - Persian: دكتر شاهین آخوندزاده
    Street address - English: Roozbeh Hospital
    Street address - Persian: بيمارستان روزبه
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1333715914
    Phone: +98 21 5541 2222
    Fax:
    Email: s.akhond@sina.tums.ac.ir
    Web page address:

Protocol summary

Study aim
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 100mg/day Spironolactone as intervention group for 8 weeks
Main outcome variables
Severity of schizophrenia

General information

Reason for update
just to correct a thypo. Indeed, in the approved proposal was 100 mg/day
Acronym
IRCT registration information
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
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 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
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 100 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. ُShahin Akhondzadeh
Street address
Roozbeh Hospital
City
Tehran
Province
Tehran
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
s.akhond@sina.tums.ac.ir
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