Topiramate vs Metformin on Cardio-Metabolic Profile in Schizophrenia on Atypical Antipsychotics

• Status: Recruiting
• Trial end date: 2023-07-30
• Target enrollment: 0
• Participant gender: All

Summary

Metabolic syndrome is common in patients of schizophrenia. It can add to morbidity, loss of functionality and discontinuation of antipsychotic medication. Apart from metformin, there are limited treatment options as add on-s to antipsychotics for treatment of metabolic syndrome. There have been placebo-controlled studies of Topiramate as an adjuvant but the present study would be the first head-on trial between these drugs for treatment of metabolic syndrome in patients of schizophrenia.

If the outcome measures show a significant improvement with add on topiramate when compared with Metformin, then add on Topiramate can be a preferred treatment for metabolic syndrome in patients with schizophrenia on atypical antipsychotics. The adverse effects of Metformin can be side-stepped and Topiramate can also be given in conditions which are contraindications for Metformin. Thus, Topiramate can be a good alternative to metformin especially in conditions like liver, cardiac and renal impairment where metformin use should be avoided. Topiramate can not only improve metabolic parameters but can also have a beneficial effect on the symptom severity of schizophrenia. Thus, it can be a good augmentation drug to be used along with antipsychotics in these patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: All India Institute of Medical Sciences, Bhubaneswar
• Treatments: Metformin; Topiramate

Criteria

Inclusion Criteria:

• Patients clinically diagnosed with schizophrenia (F20 according to ICD-10 DCR) on a stable dose of atypical antipsychotic for more than 3 months.

• Patients with metabolic syndrome (as per NCEP ATP III Definition).

• Patients above 25 years of age of either gender.

• Legally authorized representative (LAR) giving voluntary written consent for participation in the study.

Exclusion Criteria:

• Patients on combination of antipsychotics.

• Patients having any contraindication for Metformin/Topiramate.

• History of any psychoactive substance use in harmful use or dependence pattern except tobacco.

• Any co-morbid medical, psychiatric or neurological disorders like hypertension, coronary artery disease, hypothyroidism, arthritis.

• History of any significant head injury or organic diseases.

• Pregnant and breastfeeding females.