CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 60 enrolled
Drug / intervention
Metformin +1 moredrug
Likely dose
Metformin 1000mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05663749
NCT05663749Phase 4Completed

Efficacy and Safety of Add-on Topiramate vs Metformin on Cardio-Metabolic Profile in Patients With Schizophrenia on Atypical Antipsychotics With Metabolic Syndrome: a Randomized Controlled Trial

All India Institute of Medical Sciences, Bhubaneswar·interventional·Posted Dec 23, 2022·Updated Aug 22, 2023

In Brief

A Phase 4 clinical trial evaluating Metformin and Topiramate for Metabolic Syndrome and Schizophrenia. Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIndia
Collaborators--

Timeline

Phase 4CompletedFinished
2023202420252026
First PostedDec 23, 2022
Enrollment StartSep 20, 2022
Primary CompletionJul 30, 2023
Study CompletionAug 20, 2023
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 3.5 years ago

Interventions

Metformindrug

1000mg for 8 weeks

Topiramatedrug

50mg for 8 weeks