Health Condition 1: null- Newly diagnosed patients of Acute Schizophrenia
Conditions
Interventions
Intervention1: Tablet Lurasidone 40 mg OD: 40 mg tablet to be taken once daily with meals (more than 350 calories) for 42 days
Intervention2: Tablet Lurasidone 80 mg OD: 80 mg tablet to be taken once
Sponsors
MSN Laboratories Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients between 18 and 65 years (inclusive). 2. Patient meets DSM-IV criteria for primary diagnosis of Schizophrenia as established by clinical interview using M.I.N.I. (Mini International Neuropsychiatric Interview) diagnostic interview. 3. Patient is newly diagnosed with acute schizophrenia. 4. Patient has a PANSS total score >= 75 at the time of screening. 5. Patient has a score >= 4 (moderate) on 2 or more of the following PANSS items: Delusions, Conceptual disorganization, Hallucinations and Suspiciousness/persecution. 6. Patient has a score >= 4 on the CGI-S at screening. 7. Female patients of child bearing potential should have negative Urine Pregnancy Test (UPT) at the time of screening. 8. Patient or patientâ??s legally acceptable representative willing to sign the Informed Consent Document. 9.Patient willing and able to participate in all aspects of the core study, including use of oral medication, completion of subjective evaluations, and compliance with protocol requirements
Exclusion criteria
Exclusion criteria: 1. Elderly patients with dementia-related psychosis. 2. Diagnosis of mental retardation or other cognitive disorder 3. Any other Axis I psychiatric diagnosis. 4. Patient is currently on any anti-psychotic drug therapy. 5. Patient is considered by the investigator to be at imminent risk of suicide or injury to self, others or property. 6. Clinically significant suicidal or homicidal behavior or attempts within past 6 months. 7. Female patient has a positive pregnancy test at screening, is pregnant or lactating, or is planning to become pregnant during the study period. 8. Patient has received clozapine for refractory psychosis and/or patient has been treated with clozapine (for any reason) within 4 months of randomization. 9. Patient has received treatment with mood stabilizers or antidepressants within 1 week, fluexine hydrochloride at any time within 1 month or a monoamine oxidase (MAO) inhibitor with 3 weeks of randomization. 10. Presence of abnormal ECG parameters or significant cardiac disease, including uncompensated congestive heart failure, myocardial infarction within the past 6 months or known history of congenital long QT syndrome. 11. Patient requires treatment with a drug that prolongs the QT interval corrected for individual heart rate (QTc interval). 12. History of Neuroleptic Malignant Syndrome (NMS). 13. History of Orthostatic Hypotension and Syncope. 14. History of Diabetes Mellitus. 15. Patient has a history of hyperprolactinemia (prolactin concentration >100ng/mL at screening) or pituitary adenoma. 16. Patient has a history of leukopenia, neutropenia and/or agranulocytosis. 17. Patients who are currently or who will require treatment with strong CYP3A4 inhibitors (e.g., ketoconazole) or strong CYP3A4 inducers (e.g., rifampin) during the study. 18. Patients who have received or are currently on depot neuroleptics. 19. Any significant systemic disease, endocrine or metabolic abnormalities. 20. Alcohol or substance dependence within the past 12 months or abuse within the past 3 months. 21. Known hypersensitivity to any drug that will be administered during the study. 22. Inability to comply with the protocol requirements. 23. Participation in any other clinical trial within 3 months of registering in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EFFICACY: Mean change in total score of Positive and Negative Symptom Scale (PANSS) Proportion of treatment â??Respondersâ?? and â??Non-Respondersâ?? (Responders defined as patients reporting improvement of at least 28% on PANSS score) SAFETY: Proportion of patients reporting AE/ SAE Mean change in Extrapyramidal symptoms on Modified Simpson-Angus Scale (MSAS) Mean change in QT interval and heart rate on ECG; body weight, BMI, lab parameters Mean change in vital parametersTimepoint: EFFICACY: Baseline to each post randomization visit [Days 3, 5, 8, 15, 29 and 43] On Day 43 as compared to baseline SAFETY: Each post randomization visit [Days 3, 5, 8, 15, 29 and 43] Baseline to each post randomization visit [Days 3, 5, 8, 15, 29 and 43] Baseline to end of protocol therapy [Day 43] Baseline to each post randomization visit [Days 3, 5, 8, 15, 29 and 43] | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in the Clinical Global Impression â?? Severity Scale (CGI-S) scoreTimepoint: Baseline to Day 8, Day 15, Day 29, and Day 43;Mean score of Clinical Global Impression â?? Global ImprovementTimepoint: At Day 8, Day 15, Day 29, and Day 43 | — |
Countries
India
Contacts
Public ContactDr Amit Bhatt
Nexus Clinical Research (India) Ltd.
Outcome results
None listed