Topiramate’s effectiveness on weight reduction in overweight/obese persons with Schizophrenia

INTERVENTION: 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. CONDITION: Schizophrenia, Obesity, Overweight PRIMARY OUTCOME: 1) Reduction in body weight; 2) Reduction in waist circumference; 3) Reduction in skin fold thickness; SECONDARY OUTCOME: A potential change in psychiatric symptoms as measured by the brief psychiatric rating scale (BPRS) 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