A study on the efficacy and safety of Blonanserin in Indian patients in Ahmedabad: a randomized, active controlled, phase III clinical trial
Journal Title: INDIAN JOURNAL OF MENTAL HEALTH - Year 2017, Vol 4, Issue 4
Abstract
Introduction: Blonanserin is a novel atypical antipsychotic with higher dopamine D 2 receptor occupancy and lower serotonin 5-HT2A receptor blocking activity as compared to the other atypical antipsychotics.The objective of this study was to compare the efficacy and safety of blonanserin with haloperidol in Indian patients with schizophrenia. Methodology: This was an 8 week, randomized, open label, active controlled, multicentre study. Patients diagnosed with schizophrenia according to the DSM-IV criteria were enrolled in the study. Patients were randomized to receive either blonanserin (16 mg/day) or haloperidol (4.5 mg/day). Patients were assessed on an out-patient basis after every 2 weeks for clinical efficacy [Positive and Negative Syndrome Scale (PANSS) total and factor scores], Clinical Global Impressions–severity CGI-S, Clinical Global Impressions–Improvement (CGI-I), Global Assessment of Efficacy (CGI-C), adverse events and drug compliance. Results: At our centre, total 60 patients were randomized it the study with 30 patients each in Blonanserin and Haloperidol group. Both blonanserin and haloperidol were effective in reducing the PANSS score at the end of the study as compared to the baseline (P<0.001). There was a significantly more decline in the mean total PANSS score from 78.5 ± 15.6 (range: 43-105) at baseline (Week 0) to 35.0 ± 8.8 (range: 14-54) at last assessment (Week 8) in the patients enrolled in Study Arm of Blonanserin; as compared to decline in the same from 67.7 ± 14.0 (range: 39-93) at baseline (Week 0) to 31.0 ± 5.7 (range: 21-43) at last assessment (Week 8) in Study Arm of Haloperidol. Blonanserin was superior to Haloperidol in control of negative symptoms of schizophrenia. On Clinical Global Impression for change in disease severity (CGIS) at the end of treatment period;10 (35.7%) patients had “much improvement” in Blonanser in group.On the otherhand, 5 (17.2%) patients had “much improvement” in Haloperidol group. Blonanserin was welltolerated by the patients with the most common adverse event being extrapyramidal symptoms.Conclusion: Blonanserin was found to be non-inferior to haloperidol in the treatment of patients with schizophrenia and was superior to haloperidol for the treatment of negative symptoms of schizophrenia. Blonanserin has a great potential to be a new atypical first line drug for the treatment of schizophrenia.
Authors and Affiliations
Bhavesh Lakdawala, Mahemubin S. Lahori, Ganpat K. Vankar
Keywords
Related Articles
- EP ID EP274941
- DOI 10.30877/IJMH.4.4.2017.359-366
- Views 70
- Downloads 0
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