to study effect of lurasidone in patients of schizophrenia in comparison with oplanzapine
Phase 4
- Conditions
- Health Condition 1: null- Schizophrenia
- Registration Number
- CTRI/2018/01/011393
- Lead Sponsor
- Dr Bhagyashree Mohod
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
1. Patient of schizophrenia who is consulting first time to psychiatrist for the complaints
2. PANSS (positive and negative syndrome scale) score more than or equal to 80
3. Patient willing to give written informed consent.
Exclusion Criteria
Exclusion criteria :-
1)Pregnant, Nursing Women and children
2)Patients requiring other psychotropic medications, central nervous system active drugs
3)Patient with neurologic disorders (dementia, seizures, stroke), obesity , serious or not stabilized organic disorders (neoplasia, cardiovascular, pulmonary, uncontrolled type 1 or 2 diabetes)
4)Patients with any other psychiatric disorders
5)Abnormal renal/hepatic function
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the clinical efficacy of Lurasidone with Olanzapine in the treatment of schizophrenia with help of change in score on the positive and negative syndrome scale(PANSS) from baseline to week 12. Patient is responder when there will be reduction of more than or equal to 20% PANSS total score from baseline.Timepoint: 0 weeks to 12 weeks
- Secondary Outcome Measures
Name Time Method To compare the safety profile of Lurasidone with Olanzapine by assessment of <br/ ><br>Liver Function Test, Lipid profile, blood glucose level and weight.Timepoint: At 0 week and 12 weeks