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

The examination of the upper therapeutic threshold of serum clozapine level in treatment-resistant Schizophrenia: A double-blind randomized controlled trial.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/01/061731

Enrollment

Registered

2024-01-23

Start date

Unknown

Completion date

Unknown

Last updated

2024-03-04

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

Conditions

Health Condition 1: F200- Paranoid schizophrenia

Interventions

Intervention1: adfa: ssssssf Intervention2: Clozapine: Orally administered clozapine dose will be adjusted to ensure that serum clozapine level of five hundred to six hundred nanogram per ml is achiev

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

—

Countries

India

Contacts

Public ContactVijaya Kumar KG

NIMHANS, Benagaluru

vkkg24@gmail.com08026005250

Outcome results

None listed

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