Effect of adjunctive Memantine on cognitive functions, metabolic profile and brain neurometabolites in Clozapine-treated patients of Schizophrenia: A 1H-MRS Study
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Improvement of scores in cognitive function tests in patients receiving Memantine with Clozapine than those receiving Clozapine without Memantine.
研究概览
简要总结
Most of the drugs used in treating Schizophrenia are effective in treating positive symptoms. But there are no approved treatments for improving cognitive deficits and negative symptoms. Though Clozapine is efficacious, many patients only show partial response. Augmentation of Clozapine with Memantine has shown promise in improving both negative symptoms and cognitive deficits. Memantine also might help reduce the metabolic side effects of Clozapine, but this effect has not been studied enough (Veerman et al.,2014; Schaefer, et al., 2007). To the best of our knowledge, there are no MRS studies assessing the effect of Memantine as an adjunct to Clozapine on cognitive impairment in Schizophrenia and on metabolic adverse effects of Clozapine. This study plans to do the same and it is a randomized, open label study assessing the efficacy of Memantine as an adjunctive to Clozapine. The primary outcome will be improvement of scores in cognitive function tests in patients receiving Memantine with Clozapine than those receiving Clozapine without Memantine. The secondary outcomes will be improvement in BMI and lipid profile in patients receiving Memantine and Clozapine than those receiving Clozapine without Memantine and alteration in Glu, Gln, NAA, Cr concentrations in ACC in patients receiving Memantine with Clozapine than those receiving Clozapine without Memantine. All the variables will be measured at baseline, 2 weeks and 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Inpatients satisfying the ICD 11-DCR criteria for Schizophrenia, supplemented with ICD 11 for Mortality and Morbidity Statistics (February 2022 edition).
- •2.Score less than or equal to 25 in Montreal Cognitive Assessment.
- •3.Patients who are on stable doses of Clozapine.
- •4.Those who give informed consent for participating in the study.
排除标准
- •1.Pregnancy.
- •2.Lactating women, and female subjects of reproductive age without adequate contraception.
- •3.Known hypersensitivity to Memantine.
- •4.Co-medication with glutamate modulators.
- •5.Major physical illnesses (Uncontrolled epilepsy, Myocardial infarction, Uncontrolled hypertension, Renal insufficiency, Liver failure.) 6.Clinically diagnosed Intellectual disability.
- •7.Past history of significant head injury.
- •8.CDSS score more than 7 will not be included in study.
结局指标
主要结局
Improvement of scores in cognitive function tests in patients receiving Memantine with Clozapine than those receiving Clozapine without Memantine.
时间窗: Baseline, 2 weeks & 6 weeks.
次要结局
- Alteration in Glu, Gln, NAA, Cr concentrations in ACC in patients receiving Memantine with Clozapine than those receiving Clozapine without Memantine.
- Improvement in BMI & lipid profile in patients receiving Memantine and Clozapine than those receiving Clozapine without Memantine.(Baseline, 2 weeks & 6 weeks.)