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The effect of bumetanide on positive , negative and cognitive symptoms of schizophrenic patients

Protocol summary

Summary
Objectives : In this clinical trial , we want to investigate the effect of Bumetanide on positive, negative and cognitive symptoms of schizophrenic patients. Design: This study is a single-center double-blind placebo-controlled randomized longitudinal clinical trial. Sample size: 20 patients per group Blinding and randomization: Patient will randomly be divided to control and treatment groups that should participate in a double-blind study .Treatment group will take bumetanide 1mg/twice daily and control group will take placebo. Neither patients nor evaluators will not be inform about type of drugs, placebo or bumetanide. Criteria: inclusion criteria: (1) Diagnosis of schizophrenia at any subtype according to DSM-IV diagnosis an statistical manual of mental disorders, 4th edition (2) aged 20 to 70 years (3) disease duration for at least 3 years (4) had a total score of at least 70 on the positive and negative syndrome scale(PANSS) (5) had persistent negative or considerable cognitive symptoms, that are equivalent with at least 20 and 15 score on the negative and cognitive subscales of PANSS, respectively. Exclusion criteria were: patients with a (1) documented fluctuation in symptoms (2) uncontrollable significant conditions (3) As well as concurrent history of significant psychiatric (except schizophrenia), cardiovascular, renal, hepatic, convulsive disorders or substance abuse. Intervention: as we mentioned above, one group will take bumetanide 1 mg/ twice daily and control group will take same dose of placebo. Main outcome measure: Primary outcome measures: Two groups will be evaluate by PNASS, BPRS, before drug taking and 1,2 months after the drug taking and after one-month drug-free washout period. At the end, the data gathered from these four assessments will be compared. Secondary outcome measures: Two groups will be evaluate by AIMS (for side effect) before drug taking and 1,2 months after the drug taking and after one-month drug-free washout period. At the end, the data gathered from these four assessments will be compared.

General information

Acronym
Bumetanide
IRCT registration information
IRCT registration number: IRCT2014012616374N1
Registration date: 2015-12-23, 1394/10/02
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-12-23, 1394/10/02
Registrant information
Name
Mohammad Reza Khodaie Ardakani
Name of organization / entity
University of Social Welfare & Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 3340 1604
Email address
kh.ardakani@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
University of social welfare &rehabilition sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-01-21, 1394/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of bumetanide on positive , negative and cognitive symptoms of schizophrenic patients
Public title
The effect of bumetanide on schizophrenia patients
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: (1) Diagnosis of schizophrenia at any subtype according to DSM-IV diagnosis an statistical manual of mental disorders, 4th edition (2) aged 20 to 70 years (3) disease duration for at least 3 years (4) had a total score of at least 70 on the positive and negative syndrome scale(PANSS) (5) had persistent negative or considerable cognitive symptoms, that are equivalent with at least 20 and 15 score on the negative and cognitive subscales of PANSS, respectively. Exclusion criteria were: patients with a (1) documented fluctuation in symptoms (2) uncontrollable significant conditions (3) As well as concurrent history of significant psychiatric (except schizophrenia), cardiovascular, renal, hepatic, convulsive disorders or substance abuse.
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
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
Ethis committee ofuniversity of social welfare&rehabilitation sciences
Street address
University of Social Welfare & Rehabilitation Sciences، Koodakyar street، Velenjac
City
Tehran
Postal code
1985713834
Approval date
2014-02-01, 1392/11/12
Ethics committee reference number
Uswr.rec.1392.47

Health conditions studied

1

Description of health condition studied
schizopherenia
ICD-10 code
f20
ICD-10 code description
schizopherenia

Primary outcomes

1

Description
Negative, positive and cognitive symptoms of schizopherenic patients
Timepoint
Before treatment and 1, 2 months after treatment and following one-month drug-free washout period
Method of measurement
PANSS and BPRS inquiries

Secondary outcomes

1

Description
Side effect
Timepoint
at assessment interviews; before treatment and 1,2 months after treatment and after one-month drug-free washout period
Method of measurement
AIMS test and clinical observation

Intervention groups

1

Description
Control group: take placebo . tab per day . Oral during 3months
Category
Treatment - Drugs

2

Description
Intervention group: take Bumetanide(Made in Belgium) as an adjuvant therapy - made in Belgium Tab , 1mg twice daily. Oral. During 2months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
RAZI Psychiatric Hospital
Full name of responsible person
Dr. Mohammad Reza Khodaie Ardakani
Street address
RAZI Psychiatric Hospital، Amin abad، shahre Rey
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, university of Social Welfare & Rehabilitation sciences
Full name of responsible person
Hamidreza Khanke
Street address
Vice chancellor for research, University of Social Welfare & Rehabilitation Sciences, koodakiar st., Velenjac, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, university of Social Welfare & Rehabilitation 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
University of Social Welfare & Rehabilitation Sciences
Full name of responsible person
Dr. Mohammad Reza khodaie Ardakani
Position
psychiatrist-Associated professor
Other areas of specialty/work
Street address
Razi Psychiatric Hospital ، shahre Rey، Tehran
City
Tehran
Postal code
1313913139
Phone
+98 21 3340 1604
Fax
+98 21 3340 1604
Email
kh.ardakani@uswr.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Social Welfare & Rehabilitation Sciences
Full name of responsible person
Mohammad Reza khodaie Ardakani
Position
Associate Professor of psychiatry
Other areas of specialty/work
Street address
Razi psychiatric Hospital ، shahre Rey، Tehran
City
Tehran
Postal code
Phone
+98 21 3340 1604
Fax
+98 21 3340 1604
Email
kh.ardakani@uswr.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
University of Social welfare & Rehabilitation Sciences
Full name of responsible person
Mohammad Taghi Joghataei
Position
Professor
Other areas of specialty/work
Street address
University of Socigl welfare & Rehabilitation siences، Koodakyar street، Velenjac
City
Tehran
Postal code
Phone
+98 21 2218 0012
Fax
+98 22180126
Email
Mt.Joghataei@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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