Dextromethorphan as an Augmentation Agent in Treatment-resistant Schizophrenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-31

Study Completion Date

2025-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Treatment Resistant Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Add-on Dextromethorphan

Dextromethorphan 30mg once daily will be administered along with clozapine (as standard of care) in Treatment-resistant schizophrenia.

Group Type EXPERIMENTAL

Dextromethorphan

Intervention Type DRUG

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

Add-on Placebo

Matched Placebo will be administered along with clozapine (as standard of care) in Treatment resistant schizophrenia.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Dextromethorphan

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Patients with significant medical comorbidity.
* Patients with significant psychiatric comorbidity.
* Patients having active substance abuse history during the time of screening.
* Female patients who are pregnant or in reproductive age not using contraception.
* Female patients who are breast feeding

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No