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

20 Feb 2017

The date of last modification

Mar 03, 2019



Application Summary


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)


Trial Details


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

  1. Diagnosis of schizophrenia (International Classification of Diseases (ICD), 10th edition)
  2. Age 18 years and above
  3. Capacity to give informed consent (as determined by assessment of an external psychiatrist)
  4. Body Mass Index above the cut-off for Asians, which is 23 kg/m2 by the World Health Organization

Exclusion criteria

  1. Diabetes mellitus
  2. Hypertension
  3. Dyslipidaemia
  4. Patients on other weight reducing agents
  5. Patients with a significant loss of appetite leading to loss of more than 10% of body weight over a period of six months
  6. Patients with difficulty in swallowing
  7. Pregnant and lactating females


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


Date of study completion


Recruitment status

Pending


Funding source

None


Regulatory approvals

Not applicable



State of Ethics Review Approval


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 & Sponsor Information


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/

Secondary study sponsor (If any)

None





Trial Completion details


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