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NCT05663749
Topiramate vs Metformin on Cardio-Metabolic Profile in Schizophrenia on Atypical Antipsychotics
Phase 4 trial testing Metformin in Metabolic Syndrome in 60 participants. Completed in 20 August 2023.
30 July 2023
Quick facts
| Lead sponsor | All India Institute of Medical Sciences, Bhubaneswar |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 20 September 2022 |
| Primary completion | 30 July 2023 |
| Estimated completion | 20 August 2023 |
| Sites | 1 location across India |
Drugs / interventions tested
- Metformin (metformin) — full drug profile →
- Topiramate (topiramate) — full drug profile →
Conditions studied
- Metabolic Syndrome — all drugs for Metabolic Syndrome →
- Schizophrenia — all drugs for Schizophrenia →
Sponsor
All India Institute of Medical Sciences, Bhubaneswar
Who can join
25 and older, any sex, with Metabolic Syndrome or Schizophrenia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05663749
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05663749 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by All India Institute of Medical Sciences, Bhubaneswar
- Last refreshed: 22 August 2023
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing