Health Condition 1: F20- Schizophrenia
Conditions
Interventions
Intervention1: Cariprazine: The patient will be started with a minimum effective dose of 1.5 mg per day and will gradually be titrated up to 3 mg per day in 2 weeks and olanzapine will be stopped by d
Sponsors
All India Institute of Medical Sciences Patna
Eligibility
Inclusion criteria
Inclusion criteria: Patient diagnosed with Schizophrenia who had received olanzapine monotherapy at a dose of 5 to 20 mg per day for a minimum 4 weeks before inclusion Either gender Age between 18 to 65 years Significant weight gain greater than or equal to 7 percent during prior olanzapine therapy to be verified by medical record Increase in weight less than 7 percent with less than 20 percent decrease in Positive and Negative Syndrome Scale score during prior olanzapine therapy for minimum of 4 weeks Patients willing to give informed consent for the therapeutic intervention and to participate in the study
Exclusion criteria
Exclusion criteria: Patients who previously failed to respond to an adequate course of Aripiprazole (10mg to 30mg per day for greater than equal to 4 weeks) or Cariprazine (1.5 to 6 mg per day for greater than equal to 4 weeks) Other Schizophrenia spectrum disorders Highly agitated, suicidal patients who need immediate treatment Co-morbid axis I psychiatric illness Patients with co-morbid substance abuse except Nicotine use Pregnant and nursing women Patients with known history of diabetes mellitus- HbA1C greater than 6.5 percent, Patients with known history of hypertension-Blood Pressure greater than equal to 130 mm Hg systolic pressure and 85 mm Hg diastolic Pressure Patients with known history of significant neurological impairment Patient with clinical observable mental retardation History of organicity that precludes participation in study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in weight-It will be measured by difference in reading obtained by weighing machine at 6 weeks and 12 weeks from baseline.Timepoint: Baseline and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the effect of Aripiprazole on change in body weight with that of Cariprazine at 6 weeks of treatment in schizophrenia patients switched from olanzapineTimepoint: Baseline and 6 weeks;To compare the effect of Cariprazine on change in lipid profile, glucose metabolic RBS and HbA1c and anthropometric waist by hip ratio, Body Mass Index parameters with that of Aripiprazole at 6 and 12 weeks of treatment in schizophrenia patients switched from olanzapineTimepoint: baseline, 6 weeks, 12 weeks;To evaluate safety of Aripiprazole and Cariprazine in patient of schizophrenia switched from olanzapineTimepoint: baseline, 6 weeks, 12 weeks;To evaluate the efficacy of Cariprazine versus Aripiprazole measured by change in score by PANSS and SOFAS with that of Aripiprazole at 6 and 12 weeks of treatment in schizophrenia patients switched from olanzapineTimepoint: baseline, 6 weeks, 12 weeks | — |
Countries
India
Contacts
Public ContactAdarsh Verma
AIIMS Patna
Outcome results
None listed