| CTRI Number |
CTRI/2024/12/077774 [Registered on: 06/12/2024] Trial Registered Prospectively |
| Last Modified On: |
05/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A follow-up study to evaluate the effectiveness of memantine as an add on treatment for cognitive symptoms in schizophrenia |
|
Scientific Title of Study
|
Memantine as an adjuvant in cognitive symptoms of schizophrenia with chronic course a follow up 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 |
Mohammed Abdul Salaam |
| Designation |
Professor |
| Affiliation |
Konaseema institute of medical sciences and research foundation |
| Address |
Konaseema institute of medical sciences and research foundation, chaitanya health city, Amalapuram, Dr Ambedkar konaseema district, Andhra pradesh.
East Godavari
ANDHRA PRADESH
533201
India |
| Phone |
9885320662 |
| Fax |
|
| Email |
salaammd05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mohammed Abdul Salaam |
| Designation |
Professor |
| Affiliation |
Konaseema institute of medical sciences and research foundation |
| Address |
Konaseema institute of medical sciences and research foundation, chaitanya health city, Amalapuram, Dr Ambedkar konaseema district, Andhra pradesh.
East Godavari
ANDHRA PRADESH
533201
India |
| Phone |
9885320662 |
| Fax |
|
| Email |
salaammd05@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mohammed Abdul Salaam |
| Designation |
Professor |
| Affiliation |
Konaseema institute of medical sciences and research foundation |
| Address |
Konaseema institute of medical sciences and research foundation, chaitanya health city, Amalapuram, Dr Ambedkar konaseema district, Andhra pradesh.
East Godavari
ANDHRA PRADESH
533201
India |
| Phone |
9885320662 |
| Fax |
|
| Email |
salaammd05@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
mohammed Abdul Salaam |
| Address |
Konaseema institute of medical sciences and research foundation , chaitanya health city, Amalapuram, Dr Ambedkar konaseema district, Andhra pradesh. |
| Type of Sponsor |
Other [self] |
|
|
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 Mohammed Abdul Salaam |
Konaseema Institute of medical sciences and research foundation |
Room number - 14, Out patient division, Department of Psychiatry, Chaitanya health city, Amalapuram, Dr BR Ambedkar Konaseema district.
East Godavari
ANDHRA PRADESH |
9885320662
salaammd05@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe, KIMS RF |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F20||Schizophrenia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with
schizophrenia according to ICD 10 with a duration of illness more than two years, stable
without active symptomatology and on anti psychotic treatment |
|
| ExclusionCriteria |
| Details |
Patients who are not given consent and who are on on any CNS drugs |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To measure clinical utility of memantine effectiveness in schizophrenia patients along with second generation antipsychotics in
ameliorating the cognitive symptoms of schizophrenia |
Baseline: The cognitive functions at baseline
will be assessed using Addenbrooke’s cognitive examination (ACE) scale. Memantine will be
added to the ongoing treatment as an adjunctive
At the end of study: ACE scale will be repeated at the end of eight weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in cognitive symptoms score through ACE scale |
At the end of 8 weeks cognitive assessment is done using ACE scale |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2025 |
| 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="0"
Months="3"
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
|
Schizophrenia is a complex and heterogenous psychiatric illness characterized by constellation of positive, negative and cognitive symptoms. In the chronic course, the cognitive impairment remains persistent leading to socio-occupational impairment. Few studies have used memantine as an adjunctive treatment, and observed a decrease in positive, negative symptoms and improvement in cognitive symptoms and functionality. Initially , only the dopaminergic hyperactivity in the mesolimbic pathway had been described. However , recent evidence points to the involvement of glutamatergic pathways and glutamate receptors , especially the N-methyl-D-aspartate glutamatergic receptors(NMDAr), in its pathogenesis. However, antipsychotics still reamin the mainstay of treatment. Memantine is a partial uncompetitive non selective voltage dependent NMDA receptor antagonist. This was officially licensed for the treatment of moderate to severe Alzheimers disease, and has a favorable safety and tolerability profile. In recent years, studies have found glutamatergic system participation in the etiopathogenesis of schizophrenia, especially through aberrant NMDA receptors functioning, affecting the spatial and temporal organization of excitation and inhibition in neural networks that mediate cognition and behavior. Thus, drugs that modulate this activity, such as amantadine and memantine, could theoretically be used in its treatment. Memantine has been hypothesized to have a neuroprotective action in schizophrenia and other psychiatric disorders. Few case reports have explored its role as an off-label use in psychotic disorders. Moreover its effect in delaying the cognitive decline of patients with Alzheimers disease reveals a potential role for treating cognitive impairment as well as for preventing the progression of illness in schizophrenia. Several studies have focused on adjunctive use of memantine in schizophrenia, which revealed equivocal results. In some studies, adjunctive memantine treatment has been reported to decrease positive and negative symptoms, and to improve cognitive and functional level in patients with schizophrenia. Hence, our study aims to explore the effectiveness of memantine in cognitive symptoms of schizophrenia. |