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Effect of Topiramate on body weight of patients with schizophrenia treated with Olanzapine in Ibn-e- Sina Hospital in 2006.

Protocol summary

Summary
Aim of this study is effect of Topiramate on body weight of patients with schizophrenia treated with Olanzapine in Ibn-e- Sina Hospital in 2006. This study is double-blind clinical trial. 48 schizophrenic patients treated with Olanzapin which have including criteria for study at the beginning of hospitalization in Ibn-e- Sina Hospital are introduce into 4 groups randomly. Placebo, 50,100, 200 mg Topiramate is adding to their daily treatment. The inclusion criteria included: Schizophrenia according to DSM-IV-IR; aged between 18-60 years. Exclusion criteria included: Substance abuse in the past six months, a history of seizures, concomitant use of other drugs except benzodiazepines and beta-blockers. Then, patients are follow-up for 12 weeks for body weight changes, BMI, waist and wrist.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201402085280N15
Registration date: 2014-03-10, 1392/12/19
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-03-10, 1392/12/19
Registrant information
Name
Raheleh Nejati
Name of organization / entity
Mashhad University of Medical Scinces, Ibn-e- Sina Psychiatric Hospital
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2540
Email address
nejatir2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2008-11-22, 1387/09/02
Expected recruitment end date
2009-08-24, 1388/06/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Topiramate on body weight of patients with schizophrenia treated with Olanzapine in Ibn-e- Sina Hospital in 2006.
Public title
Effect of Topiramate on body weight of patients with schizophrenia treated with Olanzapine
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria included: Schizophrenia according to DSM-IV-IR; aged between 18-60 years. Exclusion criteria included: Substance abuse in the past six months, a history of seizures, concomitant use of other drugs except benzodiazepines and beta-blockers .
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 48
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
Mashhad University of Medical Sciences
Street address
Ghoreish building, Daneshgah Street.
City
Mashhad
Postal code
Approval date
2006-11-09, 1385/08/18
Ethics committee reference number
85158

Health conditions studied

1

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

Primary outcomes

1

Description
weight
Timepoint
0,1,2,4,6,8,12 weeks
Method of measurement
Balance

2

Description
Around the wrist
Timepoint
0,4,8,12 weeks
Method of measurement
Meter

3

Description
Waist
Timepoint
0,4,8,12 weeks
Method of measurement
meter

Secondary outcomes

1

Description
Clinical tests (FBS,UREA, TG, SGOT,SGPT,Cholestrol)
Timepoint
Baseline and end of plan
Method of measurement
in Laboratory

Intervention groups

1

Description
in intervention group 50 mg topiramate added to their daily treatment in 12 week.
Category
Treatment - Drugs

2

Description
in intervention group100 mg topiramate added to their daily treatment in 12 week
Category
Treatment - Drugs

3

Description
in intervention group200 mg topiramate added to their daily treatment in 12 week
Category
Treatment - Drugs

4

Description
in control group placebo added to their daily treatment in 12 week.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ibn-e- Sina Hospital
Full name of responsible person
Street address
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ardakanian Marjan
Street address
Ghoreish building, Daneshgah street.
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohammd Reza Fayyazi Bordbar
Position
Associate Professor
Other areas of specialty/work
Street address
Ibn-e-Sina Hospital, Hore Ameli blv.
City
Mashhad
Postal code
Phone
+98 51 1711 2540
Fax
Email
pbsrc@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Ali Talaei
Position
Associate Professor
Other areas of specialty/work
Street address
Ibn-E- Sina Hospital
City
Mashhad
Postal code
Phone
+98 51 1711 2540
Fax
Email
pbsrc@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Raheleh Nejati
Position
Other areas of specialty/work
Street address
City
Mashhad
Postal code
Phone
+98 51 1711 2540
Fax
Email
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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