NCT05944510

Dextromethorphan as an Augmentation Agent in Treatment-resistant Schizophrenia

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: All India Institute of Medical Sciences, Bhubaneswar · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Treatment Resistant Schizophrenia

Interventions

Type	Name	Description
DRUG	Dextromethorphan	Dextromethorphan 30mg will be administered along with Clozapine (standard of care) in treatment resistant schizophrenia.
DRUG	Placebo	Matched placebo will be administered along with Clozapine (standard of care) in treatment resistant schizophrenia.

Timeline

• Start date: 2023-08-31
• Primary completion: 2024-10-15
• Completion: 2025-04-30
• First posted: 2023-07-13
• Last updated: 2025-05-09

Locations

1 site across 1 country: India