NCT05944510CompletedPhase 4
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
Source: ClinicalTrials.gov · Last updated 9 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 6 Jul 2023
- Start date
- 31 Aug 2023
- Primary completion date
- 15 Oct 2024
- Lead sponsor
- All India Institute of Medical Sciences, Bhubaneswar
- Diseases
- Schizophrenia
- NCT number
- NCT05944510
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 40
- From 31 Aug 2023 to the primary completion date, 15 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with significant psychiatric comorbidity.
Age
- Female patients who are pregnant or in reproductive age not using contraception.
Other
- Patients with significant medical comorbidity.
- Patients having active substance abuse history during the time of screening.
- Female patients who are breast feeding
Who the study is looking for
- Schizophrenia patients who are diagnosed as treatment-resistant schizophrenia (TRS) defined as having been tried and not responded to any two antipsychotic medication for a duration of 6 weeks with dose equivalent of 600 mg of chlorpromazine and initiated on clozapine for the treatment of the same.
- The patients who are on stable dose of clozapine.
- Patients of either sex with age \>18 years.
- Patients for whom legally authorized representative (LAR) are willing to give informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| All India Institute of Medical Sciences (AIIMS) Coordinator of this site? Confirm its status | Bhubaneswar | India | Unknown status |
Related publications
- Augmentation of clozapine with dextromethorphan in treatment-resistant schizophrenia: A randomized, group sequential adaptive design, controlled clinical trial.Asian J Psychiatr · 2026 · PMID 41780197
This page is information, not medical advice. Discuss any trial with your doctor.