Is clozapine monotherapy is better than combination therapy in schizophrenia?

Phase 4

• Conditions: Health Condition 1: F202- Catatonic schizophreniaHealth Condition 2: F201- Disorganized schizophreniaHealth Condition 3: F200- Paranoid schizophreniaHealth Condition 4: F203- Undifferentiated schizophrenia

• Registration Number: CTRI/2022/03/040928
• Lead Sponsor: Seema Parija

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Patients must have clinically confirmed TRS as per the psychiatrist at the baseline.

2. Patients must have an adequate hepatic function as defined by the following:

(a) Total bilirubin = 1.5 X upper limit of normal (ULN).

(b) Transaminases [(AST/SGOT) and (ALT/SGPT)] = 3 X ULN.

3. Patients must have adequate baseline hematologic parameters as defined by:

(a) Absolute neutrophil count = 1.5 x 103/µL.

(b) Platelet count = 100 x 103/µL.

(c) Hemoglobin = 9 g/dL.

(d) In patients transfused before study entry, transfusion must be = 14 days prior to the start

of therapy to establish adequate hematologic parameters independent from transfusion support.

4. Patients must have creatinine clearance = 50 mL/min (as per MDRD formula) at the baseline

visit.

5. Patient must provide signed informed consent prior to initiation of any study-related tests or

procedures that are not part of standard-of-care for the patient’s disease.

6. Patients must agree to randomization as documented by signing the Institutional Ethics

Committee (IEC) approved consent form.

7. Patients must be willing and able to comply with study procedures.

Exclusion Criteria

1. Patients who have previously been diagnosed with one or more of the following: uncontrolled

hypertension, congestive heart failure, myocardial infarction, uncontrolled diabetes,

cerebrovascular accident, poorly controlled epilepsy, severe asthma, HIV, hepatitis B or C, or

any malignancy.

2. Patients who have a history of allergy to the study drugs.

3. Patients who have participated in any other clinical interventional studies within the last 6

months.

4. Patients who are pregnant women or lactating mothers.

Study & Design

• Study Type: Interventional
• Study Design: Not specified