| CTRI Number |
CTRI/2023/08/056148 [Registered on: 04/08/2023] Trial Registered Prospectively |
| Last Modified On: |
02/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of adding Memantine to Clozapine on cognitive functions, metabolic parameters and neuro-chemicals in patients of Schizophrenia. |
|
Scientific Title of Study
|
Effect of adjunctive Memantine on cognitive functions, metabolic profile and brain neurometabolites in Clozapine-treated patients of Schizophrenia: A 1H-MRS Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jaswanth Babu Sikha |
| Designation |
Junior Resident |
| Affiliation |
Central Institute of Psychiatry |
| Address |
Department of Psychiatry, Central Institute of Psychiatry, Kanke.
Ranchi
JHARKHAND
834006
India |
| Phone |
7702742323 |
| Fax |
|
| Email |
jaswanthbabu75@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil Kumar R Suryavanshi |
| Designation |
Associate Professor of Psychiatry |
| Affiliation |
Central Institute of Psychiatry |
| Address |
Department of Psychiatry, Central Institute of Psychiatry, Kanke.
Ranchi
JHARKHAND
834006
India |
| Phone |
8007774822 |
| Fax |
|
| Email |
sunilsuryavanshi5@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunil Kumar R Suryavanshi |
| Designation |
Associate Professor of Psychiatry |
| Affiliation |
Central Institute of Psychiatry |
| Address |
Department of Psychiatry, Central Institute of Psychiatry, Kanke.
Ranchi
JHARKHAND
834006
India |
| Phone |
8007774822 |
| Fax |
|
| Email |
sunilsuryavanshi5@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Institute of Psychiatry, Kanke, Ranchi, Jharkhand, 834006. |
|
|
Primary Sponsor
|
| Name |
Central Institute of Psychiatry |
| Address |
Kanke, Ranchi, Jharkhand, 834006 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jaswanth Babu Sikha |
Central Institute of Psychiatry |
KS Mani CCN lab and fMRI centre,
Department of Psychiatry and Department of Biochemistry, Central Institute of Psychiatry, Kanke, Ranchi, 834006.
Ranchi
JHARKHAND |
7702742323
jaswanthbabu75@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, Central Institute of Psychiatry. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F200||Paranoid schizophrenia, (2) ICD-10 Condition: F201||Disorganized schizophrenia, (3) ICD-10 Condition: F202||Catatonic schizophrenia, (4) ICD-10 Condition: F203||Undifferentiated schizophrenia, (5) ICD-10 Condition: F205||Residual schizophrenia, (6) ICD-10 Condition: F208||Other schizophrenia, (7) ICD-10 Condition: F209||Schizophrenia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
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. |
| Comparator Agent |
Clozapine without Memantine |
Patients will continue to receive a stable of dose of Clozapine throughout the period of study. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement of scores in cognitive function tests in patients receiving Memantine with Clozapine than those receiving Clozapine without Memantine. |
Baseline, 2 weeks & 6 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in BMI & lipid profile in patients receiving Memantine and Clozapine than those receiving Clozapine without Memantine. |
Baseline, 2 weeks & 6 weeks. |
Alteration in Glu, Gln, NAA, Cr concentrations in ACC in patients receiving Memantine with Clozapine than those receiving Clozapine without Memantine.
|
Baseline, 2 weeks & 6 weeks. |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
17/08/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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. |