Randomised, placebo-controlled trial on topiramate add-on therapy for weight reduction and symptomatology in overweight/obese persons with schizophrenia.

INTRODUCTION: Higher cardiovascular mortality is seen with schizophrenia due to the disorder itself and antipsychotic use. South Asians are more vulnerable to developing metabolic disorders than others. Resource-limited settings in South Asia have only a few mental health professionals, and individualised case management is mostly unavailable. Therefore, there is less monitoring and personalised support for diet and physical exercise programmes. Topiramate is useful for weight reduction and improvement of psychopathology in schizophrenia. However, there has been only one previous randomised controlled trial (RCT) done in South Asia, which possesses a quarter of the world's population. METHODS: We conducted a double-blind RCT in an outpatient setting in Sri Lanka. We compared topiramate 100 mg/day with a placebo in overweight/obese adults with schizophrenia who have been on antipsychotics for at least a year. We obtained monthly anthropometric measurements and assessed the symptomatology using the brief psychiatric rating scale (BPRS). RESULTS: Fifty patients each in the topiramate and placebo arms completed the study. Topiramate add-on therapy led to significant weight/Body Mass Index reduction and improved symptomatology as measured by the BPRS compared to the placebo. The topiramate group had significantly more reporting of loss of appetite. DISCUSSION: According to available data, this is the RCT with most participants assessing the use of topiramate in schizophrenia and only the second in South Asia. Topiramate was shown to be useful for weight reduction and symptomatic improvement in persons with schizophrenia in a resource-limited setting in South Asia.

Prevalence and correlates of depression in patients with epilepsy in Sri Lanka.

Background: Depression is one of the most common psychiatric disorders in patients with epilepsy and it is often associated with poor quality of life, increased risk of suicide and poor seizure control, yet remains underdiagnosed and undertreated. The prevalence and associations for depression in patients with epilepsy vary between studies reflecting regional and cultural influences. Therefore, it is important to identify unique attributes within a community on this phenomenon This is the first study from Sri Lanka on the prevalence and correlates of depression in patients with epilepsy. Method: We conducted this cross-sectional study at the Epilepsy clinic, Colombo North Teaching Hospital, Ragama. All consenting patients with a diagnosis of epilepsy followed up at the clinic, during study period, were enrolled. Symptoms of depression were screened with Beck Depression Inventory II and diagnosis was confirmed with a clinical assessment by psychiatrist. Results: Of 150 participants, majority were female 63.3%. (95) and 36.7% (55) of the sample were between 26-45 years. The prevalence of depressive disorder was 22% (33). The prevalence of depression was significantly associated with the recent diagnosis of epilepsy, use of multiple antiepileptic medications and duration of seizure free period (p<0.05). There is a statistically significant association between prevalence of depression with the use of carbamazepine, topiramate, clobazam and phenobarbitone. Regression analysis revealed higher the duration individuals suffering from epilepsy were at lower odds of having depression compared with that of individuals suffering from lower duration of epilepsy. For each year in increase of duration of epilepsy, the odds of depression decreased by 2% (95% CI 0.3% to 5.1%). Conclusion: The prevalence of depression is high in patients with epilepsy. Risk of having depression is higher during the early phase of the illness. Therefore, it is important to screen patients with epilepsy for depressive disorder during the early course of the illness.

Topiramate's effectiveness on weight reduction in overweight/obese persons with schizophrenia: study protocol for a randomized controlled trial.

BACKGROUND: Schizophrenia is a psychiatric disorder with a higher mortality than that of the general population. Most of the deaths are due to cardiovascular causes and are related to metabolic risks. This risk is due not only to antipsychotics but also to inherent factors of the disorder. Studies in the West have shown topiramate to be effective in schizophrenia to reduce weight gain and for symptomatic control. Whether this is effective for South Asians is not known. It is important because South Asians have a higher risk of metabolic syndrome. We aim to conduct a double-blind, randomized controlled trial comparing topiramate add-on therapy with treatment as usual with antipsychotics in patients with schizophrenia in an outpatient setting in Sri Lanka. METHODS/DESIGN: Ninety patients with schizophrenia presenting to the Colombo North Teaching Hospital will be randomized to intervention and control groups equally using permuted block randomization. Patients with comorbid metabolic disorders and taking prescribed weight-controlling medications will be excluded. The intervention group will be prescribed topiramate in addition to their antipsychotics in a predefined dosing regimen targeting a dose of 100 mg per day. The control subjects are to receive a placebo. As the primary outcome, anthropometric measurements including weight, waist circumference, skinfold thickness, and body mass index will be recorded at baseline and monthly during the study period of 3 months. The secondary outcome is the change in symptoms according to the clinician-administered Brief Psychiatric Rating Scale. Assessment of capacity will be performed and informed consent obtained from all subjects. Ethics approval has been obtained from the ethical review committee of the Faculty of Medicine, University of Kelaniya, and the trial has been registered in the Sri Lanka Clinical Trials Registry. DISCUSSION: In this double-blind, randomized controlled trial, we will attempt to assess the effectiveness of topiramate as an add-on therapy compared with treatment as usual for weight control in patients with schizophrenia. To our knowledge, this is the first such study in South Asia, where metabolic risks are found to be higher than in the West and could have unique ethnic factors related to weight gain in schizophrenia. TRIAL REGISTRATION: Sri Lanka Clinical Trials Registry, SLCTR/2017/003 . Registered on 20 February 2017. Universal trial number, U1111-1192-9439.