CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 40 enrolled
Drug / intervention
Dextromethorphan +1 moredrug
Likely dose
Dextromethorphan 30mgfrom 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/NCT05944510
NCT05944510Phase 4Completed

Dextromethorphan as an Augmentation Agent in Treatment-resistant Schizophrenia: A Randomized, Group Sequential Adaptive Design, Controlled Clinical Trial

All India Institute of Medical Sciences, Bhubaneswar·interventional·Posted Jul 13, 2023·Updated May 9, 2025

In Brief

A Phase 4 clinical trial evaluating Dextromethorphan and Placebo for Treatment Resistant Schizophrenia. Completed, enrolled 40 participants across 1 site.

Detailed Summary

Dextromethorphan acts as N-methyl-D-aspartate (NMDA) antagonist. In Treatment resistant schizophrenia(TRS) the efficacy of treatment response by clozapine is only around 40%. Numerous augmentation agent have been tried which includes antipsychotics, anticonvulsants, antidepressants and NMDA antagonist. The NMDA antagonist such as Riluzole and Memantine have shown good efficacy in TRS. Therefore we are evaluating NMDA antagonist, dextromethorphan in TRS. The dextromethorphan or placebo will be administered along with clozapine in TRS patients. The study is randomized double blind placebo controlled group sequential trial.

Study Details

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

Timeline

Phase 4CompletedFinished
202420252026
First PostedJul 13, 2023
Enrollment StartAug 31, 2023
Primary CompletionOct 15, 2024
Study CompletionApr 30, 2025
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 3.0 years ago

Interventions

Dextromethorphandrug

Dextromethorphan 30mg will be administered along with Clozapine (standard of care) in treatment resistant schizophrenia.

Placebodrug

Matched placebo will be administered along with Clozapine (standard of care) in treatment resistant schizophrenia.