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MEDTECH Iloperidone Confirms Efficacy and Safety in Bipolar Mania Treatment
Recent clinical research has focused on evaluating the efficacy of iloperidone, a second-generation antipsychotic, in treating symptoms of bipolar mania. Through a rigorous phase 3 trial, the study aimed to provide clear insights into iloperidone’s potential benefits and safety profile for individuals suffering from this challenging mental health condition.
Study Design:
- The research was a phase 3, randomized, double-blind, placebo-controlled trial.
- Conducted across 27 US and international sites from April 2021 to September 2022.
- Participants included adults diagnosed with bipolar mania.
- A total of 414 participants were randomized 1:1 to receive either iloperidone (up to 24 mg/d, administered twice daily) or a placebo for a duration of 4 weeks.
Key Findings:
- Iloperidone demonstrated a significant reduction in symptoms of bipolar mania, as measured by the Young Mania Rating Scale (YMRS), with a notable difference in least-squares mean change from baseline of -4.0 (95% CI; adjusted P=0.000008).
- Secondary efficacy endpoints, including changes in Clinical Global Impressions-Severity and Clinical Global Impression of Change scales, also showed significant improvement.
- Adverse effects reported were generally consistent with those observed in previous iloperidone studies, including tachycardia, dizziness, dry mouth, and others, but with low incidences of akathisia and extrapyramidal symptoms.
- The study concluded iloperidone is not only effective but also exhibits a tolerable and safe profile for treating bipolar mania, aligning with findings from prior research in schizophrenia without unveiling new safety concerns.
HCN Medical Memo
In this trial, iloperidone has been confirmed as an effective treatment for bipolar mania, exhibiting a tolerability and safety profile in line with previous studies on schizophrenia, without raising new safety concerns.
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