A Phase III, Randomized, Placebo-Controlled, Double-Blind Trial Evaluating the Safety and Efficacy of Sublingual Asenapine vs. Olanzapine and Placebo in In-Patients With an Acute Manic Episode Clinical Trial Protocol 7501005 (Secondary Title: ARES)

简要总结

主要结局

次要结局

• Mean Change from Baseline for Vital Signs(Baseline up to Day 21)
• Summary of Post-Baseline Markedly Abnormal Biochemistry Laboratory Changes/Values(Up to Day 21)
• Change from Baseline to Day 21 in Montgomery Asberg Depression Rating Scale (MADRS) Total Score(Baseline to Day 21)
• Change from Baseline to Day 21 in the CGI-BP Severity of Depression(Baseline to Day 21)
• Summary of Post-Baseline Markedly Abnormal Endocrinology/Miscellaneous Laboratory Changes/Values(Up to Day 21)
• Readiness for Discharge Questionnaire (RDQ)(Baseline to Day 21)
• Change from Baseline to Day 21 in Central Nervous System (CNS) Vital Signs(Baseline to Day 21)
• Change from Baseline to Day 21 in the Positive and Negative Symptom Scale (PANSS) Total Score(Baseline to Day 21)
• Adverse Events (AEs) and Serious Adverse Events (SAEs)(Up to 30 days after last dose (Up to approximately 51 days))
• Change from Baseline to Day 21 in SF-36 - Mental Component Summary Scores(Baseline to Day 21)
• Change from Baseline to Day 21 in Body Weight(Baseline to Day 21)
• Summary of Post-Baseline Markedly Abnormal Hematology Laboratory Values(Up to Day 21)
• Change from Baseline to Day 21 in the Severity of Extrapyramidal Symptoms (EPS)(Baseline to Day 21)
• Change from Baseline to Each Time Point in YMRS Total Score(Days 2, 4, 7, 14, and 21)
• Treatment Satisfaction Questionnaire for Medicine (TSQM) Overall Impact Domain Score at Day 21(Day 21)
• Change from Baseline to Day 21 in the Clinical Global Impression Scale for use in Bipolar Disorder (CGI-BP) Severity of Mania(Baseline to Day 21)
• Change from Baseline to Day 21 in Short Form-36 (SF-36) - Physical Component Summary Scores(Baseline to Day 21)
• Concomitant Medication Usage(Up to Day 21)
• Change from Baseline to Day 21 in the CGI-BP Severity of Overall Bipolar Illness(Baseline to Day 21)
• Summary of Post-Baseline Markedly Abnormal Metabolic Chemistry Laboratory Changes/Values(Up to Day 21)
• Pharmacokinetics - Plasma asenapine concentrations(Day 1 (pre-dose), 7, 14 and 21 (or endpoint))