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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
Dextromethorphan 30mg will be administered along with Clozapine (standard of care) in treatment resistant schizophrenia.
Matched placebo will be administered along with Clozapine (standard of care) in treatment resistant schizophrenia.
All India Institute of Medical Sciences (AIIMS)
Bhubaneswar, Odisha, India
Positive and negative symptom scale score
The change in symptom scoring of schizophrenia at 12 weeks from baseline using Positive and negative symptom scale in the study groups. On this scale, total minimum score= 30, maximum score= 210. Higher score denotes a worse outcome.
Time frame: Baseline and 12 weeks
Responder rate
To analyze and compare responder rate between study groups. The responder rate is defined as ≥ 20% reduction in PANSS score at 12 weeks from baseline.
Time frame: 12 weeks
Incidence of clozapine resistance
To evaluate the proportion of patients developing clozapine resistance after 12 weeks of therapy.
Time frame: 12 weeks
Requirement of clozapine dose modification
To evaluate the proportion of patients requiring clozapine dose increments or decrements over 12 weeks
Time frame: 12 weeks
Clinical global impression scoring
To evaluate for clinical status according to the clinical global impression scale. Clinical global impression is presented in a scale of 1-7. High score denotes a worse outcome.
Time frame: 12 weeks
Mini-mental state score
The change in cognition as assessed by mini-mental state examination on a 30-point questionnaire at 12 weeks from baseline. Minimum and maximum score on this scale is 0 and 30. Lower score denotes worse outcome.
Time frame: Baseline and 12 weeks
Serum clozapine level
To evaluate serum clozapine levels (trough level) at baseline and follow-up at 12 weeks.
Time frame: Baseline and 12 weeks
Incidence of treatment-emergent adverse events
To evaluate and compare the incidence of treatment-emergent adverse events in both groups.
Time frame: 12 weeks
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