Health Condition 1: null- Schizophrenia Health Condition 2: F209- Schizophrenia, unspecified
Conditions
Interventions
Intervention1: Blonanserin tablets: 1 tablet twice daily after meals for entire study period
Control Intervention1: Haloperidol tablets: 1 tablet thrice daily for entire study period
Sponsors
Cadila Healthcare Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients between 18-65 years of age. 2. Patients with diagnosis of schizophrenia. 3. Informed consent.
Exclusion criteria
Exclusion criteria: 1.Pregnancy and/or lactation. 2.Patients with suicidal tendencies. 3.Patients with relevant CNS disorders or history of such disorders. 4.Patients with a history of neuroleptic malignant syndrome (NMS). 5.Patients with uncontrolled diabetes or significant cardiovascular diseases. 6.Patients with angle-closure glaucoma, benign prostatic hyperplasia, urinary retention or paralytic ileus. 7.Patients with significant renal or hepatic impairment, acute infections, leucopenia, hyperthyroidism or SIADH. 8.Impoverished patients. 9.Patients with an organic psychiatric disorder. 10.History of hypersensitivity to study medication. 11.Patients requiring concomitant treatment which is not permissible. 12.Patients with any other serious concurrent illness or malignancy. 13.Patients with continuing history of alcohol and/or drug abuse. 14.Participation in another clinical trial in the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The degree of improvement in the PANSS total scoreTimepoint: Baseline, monthly & at the end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) The degree of improvement in the PANSS factor scores (2) The degree of improvement in the Clinical Global Impressions (CGI) ? severity and improvement scoresTimepoint: Baseline, monthly & at the end of study | — |
Countries
India
Contacts
Public ContactDr Amit Kubavat
Cadila Healthcare Ltd.
Outcome results
None listed