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to study effect of lurasidone in patients of schizophrenia in comparison with oplanzapine

Comparative evaluation of efficacy & safety of Lurasidone & Olanzapine in patients of Schizophrenia:A Randomized,Parallel,Open-label, Clinical study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/01/011393
Enrollment
60
Registered
2018-01-18
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Schizophrenia

Interventions

Intervention1: Lurasidone: Tab lurasidone 40 mg OD After four weeks of treatment, dose may be increased to lurasidone 80mg/day in case of insufficient improvement of schizophrenic symptoms as per

Sponsors

Dr Bhagyashree Mohod
Lead Sponsor

Eligibility

Inclusion criteria

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: 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
To compare the safety profile of Lurasidone with Olanzapine by assessment of Liver Function Test, Lipid profile, blood glucose level and weight.Timepoint: At 0 week and 12 weeks

Countries

India

Contacts

Public ContactDr Bhagyashree Mohod

Government Medical College Nagpur

drsunil_mm@rediffmail.com9422812306

Outcome results

None listed

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