MedTrace Logo

Dextromethorphan as an Augmentation Agent in Treatment-resistant Schizophrenia

NCT05944510 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-05-09

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • All India Institute of Medical Sciences, Bhubaneswar

    lead OTHER

Principal Investigators

  • DEBASISH HOTA, D.M. · AIIMS Bhubaneswar

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-31
Primary Completion
2024-10-15
Completion
2025-04-30

Countries

  • India

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05944510 on ClinicalTrials.gov