Obesity
Conditions
Keywords
metformin, topiramate, obesity, metabolic syndrome
Brief summary
The primary aim of the study is to investigate the efficacy of metformin and topiramate on second-generation antipsychotic-induced obesity. The secondary domain we look at is the adverse effects of both drugs. The investigators hypothesize that metformin and topiramate are effective in treating obesity induced by second-generation antipsychotics.
Interventions
DRUGmetformin, topiramate
metformin 250 mg/d is gradually increased to 1000 mg/d over four weeks, and topiramate 50 mg/d is gradually increased to 200 mg/d over four weeks
Sponsors
Beitou Armed Forces Hospital, Taipei, Taiwan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosis: schizophrenia or schizoaffective disorder 2. Age: 20 to 65 3. BMI\>27 4. Receiving second-generation antipsychotics(Olanzapine, Clozapine, Quetiapine, Risperidone, Amisulpride, Zotepine)
Exclusion criteria
1. Allergy to metformin or topiramate 2. Currently taking metformin or topiramate 3. Currently taking drugs that may interact with topiramate, including carbamazepine, eslicarbazepine, oxcarbazepine, phenobarbital, phenytoin, primidone, amitriptyline, lithium, metformin, propranolol, and sumatriptan. 4. Being pregnant or planning to become pregnant during the study period, 5. History of hypertension, DM, liver or renal function impairment, cardiovascular disease, CVA, or neurological disorders 6. History of hypoglycemia 7. History of suicidal attempt 8. Current scale of Hamilton Depression Rating Scale\>8
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The changes in metabolic panel as the primary outcome | up to six months | Metabolic panel, which includes HDL-C, VLDL, LDL, cholesterol, triglycerides, insulin, leptin, BW, Glucose, blood pressure, and weight(with waist circumference and BMI) will be assessed every month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events (including psychiatric adverse events) as a Measure of Safety and Tolerability | up to six months | We use Positive and Negative Syndrome Scale, the Hamilton Depression Rating Scale, clinical golbal impression-severity, and the Udvalg for Kliniske Undersøgelser Side Effect Rating Scale every month to investigate the participants' safety and tolerability. |
Countries
Taiwan
Outcome results
None listed