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

Prevalence of metabolic syndrome and its risk factors in patients receiving Clozapine therapy for schizophrenia- A prospective observational study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/07/070464
Enrollment
165
Registered
2024-07-11
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Health Condition 1: F209- Schizophrenia, unspecified

Interventions

Intervention1: Clozapine: Patients of Schizophrenia receiving Clozapine will be prospectively observed for development of Metabolic Syndrome Intervention2: NIL: NIL

Sponsors

AIIMS Raipur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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).

Design outcomes

Primary

MeasureTime frame
proportion of patients with Schizophrenia on Clozapine showing increased risk for metabolic syndromeTimepoint: 6 months

Secondary

MeasureTime frame
To assess clozapine-related adverse drug reactions and their frequency in the study population.Timepoint: 6 months;To assess the improvement in symptomsTimepoint: 6 months;To assess the risk for developing diabetesTimepoint: 6 months;To check for adherence to Clozapine therapy in patients with schizophreniaTimepoint: 6 months

Countries

India

Contacts

Public ContactPugazhenthan Thangaraju

All India Institute of Medical Sciences (AIIMS) Raipur

drpugal23@gmail.com9486279090

Outcome results

None listed

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