Home » Trials » SLCTR/2010/004
Metformin for treatment of atypical antipsychotic induced weight gain: a randomized double blind placebo controlled trial
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SLCTR Registration Number
SLCTR/2010/004
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
Metformin for treatment of atypical antipsychotic induced weight gain: a randomized double blind placebo controlled trial
Public Title of Trial
Effectiveness of metformin in reducing weight gain caused by antipsychotics
Disease or Health Condition(s) Studied
Schizophrenia
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
EC-09-133 (Ethics Review Committee of the Faculty of Medicine, University of Colombo)
What is the research question being addressed?
Is metformin effective in producing weight loss in patients who are already on antipsychotics and have gained more than10% of their pretreatment weight?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Placebo
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Available
Intervention(s) planned
The study drug is metformin. Intervention group will be given metformin and the control group a similar appearing placebo one tablet tds. Intervention group Metformin dose- commencing dose 250mg b.d. after reviewing for tolerance will be increased if necessary to a maximum of 500mg tds. During the first week after commencement of metformin FBS will be done daily to identify any hypoglycaemia. Both groups will be given advice regarding nutrition and exercise but will not be assigned specific diet or exercise program
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
change in total body weight |
[ Baseline, 12 weeks and 24 weeks ] |
Secondary outcome(s)
|
1.
Body Mass Index (BMI), waist/hip ratio, fasting blood sugar, lipid profile |
[ Baseline, 12 weeks and 24 weeks ] |
Target number/sample size
128 (64+64)
Countries of recruitment
Sri Lanka
Anticipated start date
2010-07-15
Anticipated end date
2011-07-15
Date of first enrollment
Date of study completion
Recruitment status
Recruiting
Funding source
Faculty of Medicine, Colombo, Sri Lanka
Regulatory approvals
Status
Approved
Date of Approval
2010-01-21
Approval number
EC-09-133
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Colombo |
| Institutional Address: | No. 25, Kynsey Road, Colombo 00800 Sri Lanka |
| Telephone: | +94-11-2695300 (Extension: 240) |
| Email: | ethicscommitteemfc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. Varuni de Silva
Senior Lecturer in Psychiatry
Faculty of Medicine, Colombo. Kynsey Road, Colombo 08,
2574011 2691581
varunidesilva2@yahoo.co.uk
Contact Person for Public Queries
Dr. Varuni de Silva
Senior Lecturer in Psychiatry
Faculty of Medicine, Colombo. Kynsey Road, Colombo 08,
2574011 2691581
varunidesilva2@yahoo.co.uk
Primary study sponsor/organization
Faculty of Medicine
Kynsey Road, Colombo 08
2691688 2691581
psych_med@yahoo.com
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
