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Effect of adding Memantine to Clozapine on cognitive functions, metabolic parameters and neuro-chemicals in patients of Schizophrenia.

Effect of adjunctive Memantine on cognitive functions, metabolic profile and brain neurometabolites in Clozapine-treated patients of Schizophrenia: A 1H-MRS Study - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/08/056148
Enrollment
44
Registered
2023-08-04
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F202- Catatonic schizophrenia Health Condition 2: F201- Disorganized schizophrenia Health Condition 3: F208- Other schizophrenia Health Condition 4: F200- Paranoid schizophrenia Health Condition 5: F205- Residual schizophrenia Health Condition 6: F209- Schizophrenia, unspecified Health Condition 7: F203- Undifferentiated schizophrenia

Interventions

Intervention1: Adjunctive Memantine therapy: Tablet Memantine 5mg twice a day for 2 weeks followed by 10mg twice a day for 4 weeks in patients of Schizophrenia treated with Clozapine. Control Interven

Sponsors

Central Institute of Psychiatry
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Alteration in Glu, Gln, NAA, Cr concentrations in ACC in patients receiving Memantine with Clozapine than those receiving Clozapine without Memantine. 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.

Countries

India

Contacts

Public ContactDr Sunil Kumar R Suryavanshi

Central Institute of Psychiatry

sunilsuryavanshi5@gmail.com8007774822

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026