pper dose range of clozapine in treatment-resistant schizophrenia: A randomised controlled study

Phase 4

• Conditions: Health Condition 1: F200- Paranoid schizophrenia

• Registration Number: CTRI/2024/01/061731
• Lead Sponsor: Indian Council of Medical Research, New Delhi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

•Diagnosis of Schizophrenia as per ICD 11

•Diagnosed with treatment resistant schizophrenia for positive symptoms subdomain as per the Treatment Response and Resistance in Psychosis (TRRIP) working group consensus guidelines

•Male gender

•18-45 years of age

•No active use of tobacco after about 7 days of clozapine initiation

Exclusion Criteria

1. Uncooperative for psychopathology assessment

2. Need for Electroconvulsive therapy

3. A recent history of high-grade fever or infection within the past two weeks

4. Co-existing disease that can potentially influence nervous system

5. Treatment with medications known to affect nervous systems or serum clozapine levels

6. Co-morbid substance abuse or dependence except for nicotine dependence syndrome; co-morbid Axis I Psychiatry disorder

7. Any significant medical or neurological disorder that might interfere with sleep or cognition.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the change in the positive symptoms in TRS as measured with SAPS between the three serum clozapine-level intervention groups. <br/ ><br>Timepoint: Baseline (beginning of phase 2 of the study) and after 6 weeks of achieving the intended serum clozapine level

Secondary Outcome Measures

Name	Time	Method
To find out the time course of treatment response with clozapine in TRS <br/ ><br>To compare the change in the negative and cognitive symptoms and CGI severity of illness between the three serum clozapine-level intervention groups. <br/ ><br>To compare the adverse effects between the groups at the end point of the double-blind RCT <br/ ><br>Timepoint: Baseline (beginning of phase 2 of the study) and after 6 weeks of achieving the intended serum clozapine level