Health Condition 1: F202- Catatonic schizophrenia Health Condition 2: F201- Disorganized schizophrenia Health Condition 3: F200- Paranoid schizophrenia Health Condition 4: F203- Undifferentiated schizophrenia
Conditions
Interventions
Intervention1: CLOZAPINE: Clozapine dose will be titrated as per the standard guidelines. The standard titration starts with clozapine 25 mg daily given in 2 divided
doses, and then clozapine is incre
Sponsors
Seema Parija
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To determine the Positive And Negative Syndrome Scale (PANSS) score of the study groups at baseline and 6 months. 2. To assess non-inferiority of clozapine monotherapy to combination of clozapine and risperidone at 6 months.Timepoint: baseline, 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the Positive And Negative Syndrome Scale (PANSS) score of the study groups at baseline, 1 month, and 3 months.Timepoint: baseline, 1 month, and 3 months;To determine the Social and Occupational Functioning Assessment Scale (SOFAS) score of the study groups at baseline, 1 month, 3months, and 6 months.Timepoint: baseline, 1 month, 3months, and 6 months;To assess the Glasgow Antipsychotic side effects scale for clozapine (GASS-C)13 of the study groups at 1 month, 3months, and 6 months.Timepoint: 1 month, 3months, and 6 months;To assess the treatment-emergent adverse events of the study groups at 1 month, 3months, and 6 months.Timepoint: 1 month, 3months, and 6 months | — |
Countries
India
Contacts
Public ContactJyoti Prakash Sahoo
SCB Medical College, Cuttack
Outcome results
None listed