Home » Trials » SLCTR/2017/003
Topiramate’s effectiveness on weight reduction in overweight/obese persons with Schizophrenia: A Randomized Controlled Trial
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SLCTR Registration Number
SLCTR/2017/003
Date of Registration
The date of last modification
Jul 09, 2019
Scientific Title of Trial
Topiramate’s effectiveness on weight reduction in overweight/obese persons with Schizophrenia: A Randomized Controlled Trial
Public Title of Trial
Topiramate’s effectiveness on weight reduction in overweight/obese persons with Schizophrenia
Disease or Health Condition(s) Studied
Schizophrenia, Obesity, Overweight
Scientific Acronym
TOWERS (Topiramate’s effectiveness on Weight Reduction in overweight/obese persons with Schizophrenia)
Public Acronym
TOWERS (Topiramate’s effectiveness on Weight Reduction in overweight/obese persons with Schizophrenia)
Brief title
Topiramate for weight reduction in overweight/obese individuals with schizophrenia
Universal Trial Number
U1111-1192-9439
Any other number(s) assigned to the trial and issuing authority
P/96/08/2016 (ERC: Kelaniya)
What is the research question being addressed?
What is the effectiveness of Topiramate compared to a placebo in reducing the weight of overweight/obese persons with schizophrenia?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Placebo
Assignment
Parallel
Purpose
Other
Study Phase
Phase 4
Intervention(s) planned
The study will be carried out at the outpatient psychiatry clinic of the Colombo North Teaching Hospital, Ragama, Sri Lanka.
Consenting participants meeting inclusion criteria will be allocated into two arms by the allocation generation method, the restricted method to ensure balanced group sizes. Permuted block randomization is to be employed with an allocation ratio of 1:1. A block of allocations will have 10 participants and five for each group. From the potential recruitments the participants will be selected using random numbers generated by an online random number generator such as www.random.org.
A closed opaque envelope with random numbers is the preferred method of the researchers for the randomization. The participants and the researchers would be blind to the group of the study they would belong to. An external independent person would conduct the allocations. The staff members who would be attending to the routine clinic issues of the patient will be independent from the researchers. .
The intervention arm will receive an initial dose of topiramate 25mg nocte, to be titrated fortnightly by 25-50mg to reach a target dosage of 100g twice daily.
The control group will receive a matching placebo containing a minute amount of starch, which will be incremented in a similar manner.
All other treatment decisions would be independent of the study and would be according to standard protocols of the unit.
Outcomes will be assessed by doctors who will be blind to the treatment status of the participant.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Reduction in body weight |
[ At base line and then every four weeks until the completion of 3 months from commencement of the intervention ] |
|
2.
Reduction in waist circumference |
[ At base line and then every four weeks until the completion of 3 months from commencement of the intervention ] |
|
3.
Reduction in skin fold thickness |
[ At base line and then every four weeks until the completion of 3 months from commencement of the intervention ] |
Secondary outcome(s)
|
1.
A potential change in psychiatric symptoms as measured by the brief psychiatric rating scale (BPRS) |
[ At base line and then every four weeks until the completion of 3 months from commencement of the intervention ] |
Target number/sample size
90 (45 each for study and control groups)
Countries of recruitment
Sri Lanka
Anticipated start date
2017-03-03
Anticipated end date
2017-11-03
Date of first enrollment
2017-03-03
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
None
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2017-01-10
Approval number
P/96/08/2016
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | PO Box 6, Thalagolla Road, Ragama Sri Lanka |
| Telephone: | +94-11-2961267 |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Miyuru Chandradasa
Lecturer in Psychiatry
Department of Psychiatry
Faculty of Medicine
University of Kelaniya
Ragama
+94710443352
+94710443352
miyuruc@kln.ac.lk
http://www.kln.ac.lk/medicine/depts/phychiatry/dr-miyuru-chandradasa.html
Contact Person for Public Queries
Dr. Sameera Ruwanpriya,
Senior Registrar in Psychiatry,
Colombo North Teaching Hospital,
Ragama
+94713608231
sameeraruwanpriya@yahoo.com
Primary study sponsor/organization
Department of Psychiatry
Faculty of Medicine, University of Kelaniya, Thalagolla Road, Ragama
Sri Lanka
Tel: 0112961119
Fax: 0112958337
http://medicine.kln.ac.lk/depts/psychiatry/
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
