CTRI

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CTRI Number

CTRI/2024/07/070464 [Registered on: 11/07/2024] Trial Registered Prospectively

Last Modified On:

11/07/2024

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Cohort Study

Study Design

Single Arm Study

Public Title of Study

A study to find out whether clozapine results in development of metabolic syndrome in Schizophrenia patients

Scientific Title of Study

Prevalence of metabolic syndrome and its risk factors in patients receiving Clozapine therapy for schizophrenia- A prospective observational 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 Renu Thakur
Designation	Resident doctor
Affiliation	All India Institute of Medical Sciences, Raipur
Address	Department of Pharmacology,Second floor, Medical college building,AIIMS Campus,GE Road,Tatibandh,Raipur Raipur CHHATTISGARH 492099 India
Phone	8602376779
Fax
Email	renuthakur.nimhans@gmail.com

Details of Contact Person
Scientific Query

Name	Pugazhenthan Thangaraju
Designation	Assistant Professor
Affiliation	All India Institute of Medical Sciences (AIIMS) Raipur
Address	Department of Pharmacology,Second floor, Medical college building,AIIMS Campus,GE Road,Tatibandh,Raipur Raipur CHHATTISGARH 492099 India
Phone	9486279090
Fax
Email	drpugal23@gmail.com

Details of Contact Person
Public Query

Name	Pugazhenthan Thangaraju
Designation	Assistant Professor
Affiliation	All India Institute of Medical Sciences (AIIMS) Raipur
Address	Department of Pharmacology,Second floor, Medical college building,AIIMS Campus,GE Road,Tatibandh,Raipur Raipur CHHATTISGARH 492099 India
Phone	9486279090
Fax
Email	drpugal23@gmail.com

Source of Monetary or Material Support

All India Institute Of Medical Sciences(AIIMS) Raipur,Great Eastern Road,Tatibandh ,Raipur,Chattisgragh,492099

Primary Sponsor

Name	AIIMS Raipur
Address	AIIMS(All India Institute of Medical sciences) Raipur,GE Road, Tatibandh,Raipur, Chhattisgarh, India Pin code- 492099
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Renu Thakur	AIIMS Raipur	Department of Psychiatry, 1st floor, C block, All India Institute of Medical Sciences Raipur, GE Road, Tatibandh, Raipur, Chhattisgarh- 492099 Raipur CHHATTISGARH	8602376779 renuthakur.nimhans@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institute Ethics Committee, AIIMS Raipur	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: F209\|\|Schizophrenia, unspecified,

Intervention / Comparator Agent

Type	Name	Details
Intervention	NIL	NIL

Inclusion Criteria

Age From	18.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	1. All genders aged between 18 years to 65 years. 2. All patients with Schizophrenia diagnosed as per International Classification of disease 10 (ICD-10). 3. Patients prescribed Clozapine. 4. Medically stable patients.

ExclusionCriteria

Details

1. Unstable patients i.e. patients with violence, suicide risk, and risk of harm to self/others.
2. Patients with diagnosable intellectual disability.
3. Pregnant or lactating patients.
4. Medically unstable patients.
5. Severely physical disability or locomotive disability.
6. History of substance dependence other than tea or coffee.
7. History of significant weight loss in the past month.
8. Patients on metabolism-friendly medication (Such as Aripiprazole, Brexpiprazole, Lurasidone, Topiramate etc).

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
proportion of patients with Schizophrenia on Clozapine showing increased risk for metabolic syndrome	6 months

Secondary Outcome

Outcome	TimePoints
To assess the risk for developing diabetes	6 months
To assess the improvement in symptoms	6 months
To assess clozapine-related adverse drug reactions and their frequency in the study population.	6 months
To check for adherence to Clozapine therapy in patients with schizophrenia	6 months

Target Sample Size

Total Sample Size="165"
Sample Size from India="165"
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)

01/08/2024

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

There is a high prevalence of metabolic syndrome in our country. In a vulnerable population such as psychotic patients, it becomes especially important to monitor MetS as atypical antipsychotics are well known to produce metabolic disturbances. This would enable us to develop strategies and standard operating procedures for monitoring these patients to prevent these disorders and improve treatment adherence.

In this study we aim to identify the prevalence of Metabolic Syndrome in patients undergoing Clozapine therapy for patients of Schizophrenia.

Hypothesis- Clozapine therapy leads to increased risk of acquiring metabolic syndrome in patients with schizophrenia.