Dextromethorphan as an Augmentation Agent in Treatment-resistant Schizophrenia: A Randomized, Group Sequential Adaptive Design, Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Positive and negative symptom scale score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Add-on Dextromethorphan
Dextromethorphan 30mg once daily will be administered along with clozapine (as standard of care) in Treatment-resistant schizophrenia.
干预措施: Dextromethorphan (Drug)
Add-on Placebo
Matched Placebo will be administered along with clozapine (as standard of care) in Treatment resistant schizophrenia.
干预措施: Placebo (Drug)
结局指标
主要结局
Positive and negative symptom scale score
时间窗: Baseline and 12 weeks
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.
次要结局
- Responder rate(12 weeks)
- Incidence of clozapine resistance(12 weeks)
- Requirement of clozapine dose modification(12 weeks)
- Clinical global impression scoring(12 weeks)
- Mini-mental state score(Baseline and 12 weeks)
- Serum clozapine level(Baseline and 12 weeks)
- Incidence of treatment-emergent adverse events(12 weeks)
研究者
RITUPARNA MAITI
Professor
All India Institute of Medical Sciences, Bhubaneswar