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Comparison of the rate of weight change with treatment by famotidine and placebo in psychiatric patients receving olanzapine in Golestan Hospital,Ahvaz

Protocol summary

Summary
The aim of this study was to compare the efficacy of famotidine with placebo in reducing the use of olanzapine induced weight gain in patients with psychiatric disorders.This is a double-blind randomised placebo controlled clinical trial.20 to 55-year-old patients with psychiatric disorders other drugs, the effects produced are obese, do not receive , if indications are treated with olanzapine.Before olanzapine, body mass index and weight will be recorded.By assistant psychiatry, history of psychiatric problems, physical problems and side effects of medicines taken and physical examination and mental status examination will be done.The total number of participants is 44 people. Patients in both treatment and control groups of 22 individuals participated in the study. Then a group of patients, is given 40 mg famotidine at 8 am and the other group is given placebo at 8 am each day for 2 months. Patients were treated for two months weight, body mass index measured in weeks 6,4,2,0 and 8.In the case of discharge in the middle of the project, patients are followed at home by telephone.It should be noted that placebo famotidine in order to accept the cost of the project will be made by the School of Pharmacy, University Jundishapur in shape, size and color used with the drug famotidine quite similar.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015052022349N1
Registration date: 2016-02-03, 1394/11/14
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-02-03, 1394/11/14
Registrant information
Name
Arman Zarghami
Name of organization / entity
Jundishapur University of Medical Sceince
Country
Iran (Islamic Republic of)
Phone
+98 61 3337 7885
Email address
zarghami.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2015-04-21, 1394/02/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the rate of weight change with treatment by famotidine and placebo in psychiatric patients receving olanzapine in Golestan Hospital,Ahvaz
Public title
Famotidine impact on weight gain associated with olanzapine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Patients 20 to 55 years with psychiatric disorders; Non-pregnant;No history of medical conditions increase weight Exclusion criteria: Patients who have serious health problems including liver or kidney disease;Use of other medications with potential weight gain ; Patients who have a body mass index greater than 30
Age
From 20 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 44
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
Ahvaz Jundishapur University of Medical Sciences
Street address
ahvaz.univercity town
City
ahvaz
Postal code
Approval date
2015-03-14, 1393/12/23
Ethics committee reference number
IR.AJUMS.REC.1394.13

Health conditions studied

1

Description of health condition studied
Schizophrenia disorder
ICD-10 code
F20
ICD-10 code description
Schizophrenia

2

Description of health condition studied
bipolar disorder
ICD-10 code
F31
ICD-10 code description
Bipolar affective disorder

3

Description of health condition studied
Major deppresion disorder
ICD-10 code
F32
ICD-10 code description
Depressive episode

Primary outcomes

1

Description
Weight.BMI
Timepoint
week 0,2,4,6,8 during intervention
Method of measurement
Weight, balance(kg),BMI,The ratio of weight to height squared

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:Famotidine 40 mg tablet,one tablet daily, for two months
Category
Treatment - Drugs

2

Description
Control group: oral placebo tablets,one tablet daily,for two months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Dr.Arman Zarghami
Street address
Golestan Hospital,Department of Psychiatry
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Saaki Naader
Street address
Vice Chancellor for Research of Jundishapur University of Medical Science,
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur University of Medical 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
Ahvaz Jundishapur of Medical Science
Full name of responsible person
Arman Zarghami
Position
Resident of Psychiatry
Other areas of specialty/work
Street address
Golestan Hospital, Department of Psychiatry
City
Ahvaz
Postal code
Phone
+98 61337430019
Fax
Email
leyuna_z@yahoo.comzarghami.a@ajums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Jundishapur University of Medical Science
Full name of responsible person
Arman Zarghami
Position
Resident of Psychiatry
Other areas of specialty/work
Street address
Golestan Hospital, Department of Psychiatry
City
Ahvaz
Postal code
Phone
+98 61337430019
Fax
Email
leyuna_z@yahoo.comzarghami.a@ajums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur of Medical Science
Full name of responsible person
Arman Zarghami
Position
Resident of Psychiatry
Other areas of specialty/work
Street address
Golestan Hospital, Department of Psychiatry
City
Ahvaz
Postal code
Phone
+98 61337430019
Fax
Email
leyuna_z@yahoo.comzarghami.a@ajums.ac.ir
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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