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 7501004 (Secondary Title: ARES)

简要总结

主要结局

次要结局

• The Readiness for Discharge Questionaire (RDQ) was administered to characterize the subject's readiness for discharge. The investigator was to make the decision about discharging the subject.(The RDQ was administered on Day 1, 2, 4, 7 , 14 and 21 (or at the time of the last assessment))
• The SARS (Simpson Angus Rating Scale); the AIMS (Involuntary Movement Scale and the BARS (Barnes Akathisia Scale) were used to assess extrapyramidal symptoms(The SARS, AIMS and BARS assessments were administered at Days 1, 7 and 21 or endpoint.)
• Physical examination, laboratory and electrocardiogram findings and weight/abdominal girth and vital signs were recorded.(Physical exam, ECG, laboratory and weight were recorded at screening and Day 21 or endpoint. Laboratory work was also done at baseline.)
• Adverse events (AEs)(AEs were recorded whenever they occurred..)
• The PANSS (Positive and Negative Symptom Scale) was used to assess psychotic symptoms(The PANSS was administered at Days 1, 7 and 21(or the time of the last assessment).)
• CogState, cognition battery, was used to assess changes in cognition(Cog State was administered at screening, Day 1 (baseline) and Days 7, 14, 21 (or endpoint).)
• Concomitant medication use was recorded(Concomitant medication use was recorded whenever it occurred)
• Pharmacokinetic analysis was done to determine the level of the drug in the blood(Pk samples were taken at Day 1, 7, 14 and 21 (or endpoint).)
• Ratings on the Clinical Global Impression scale in which severity and improvement of mania, depression, and overall bipolar state are rated.(The CGI assessment at days 1,7 and endpoint (day 21 or the time of the last assessment).)
• The MADRS (Montgomery Asberg Depression Rating Scale) was used to assess depressive symptoms(The MADRS was administered on Days 1, 7 and 21(or at the time of the last assessment).l)
• SF (short form)-36 and TSQM (Treatment Satisfaction Questionnaire for Medication) -- 2 measures of Quality of Life were administered.(The SF Health Survey was administered at Day 1 and Day 21 or endpoint. The TSMQ was administered at Day 21 or endpoint..)