Effect of adding Memantine to Clozapine on cognitive functions, metabolic parameters and neuro-chemicals in patients of Schizophrenia.
- Conditions
- Health Condition 1: F202- Catatonic schizophreniaHealth Condition 2: F201- Disorganized schizophreniaHealth Condition 3: F208- Other schizophreniaHealth Condition 4: F200- Paranoid schizophreniaHealth Condition 5: F205- Residual schizophreniaHealth Condition 6: F209- Schizophrenia, unspecifiedHealth Condition 7: F203- Undifferentiated schizophrenia
- Registration Number
- CTRI/2023/08/056148
- Lead Sponsor
- Central Institute of Psychiatry
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement of scores in cognitive function tests in patients receiving Memantine with Clozapine than those receiving Clozapine without Memantine.Timepoint: Baseline, 2 weeks & 6 weeks.
- Secondary Outcome Measures
Name Time Method Alteration in Glu, Gln, NAA, Cr concentrations in ACC in patients receiving Memantine with Clozapine than those receiving Clozapine without Memantine. <br/ ><br> <br/ ><br>Timepoint: Baseline, 2 weeks & 6 weeks.;Improvement in BMI & lipid profile in patients receiving Memantine and Clozapine than those receiving Clozapine without Memantine.Timepoint: Baseline, 2 weeks & 6 weeks.