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)

Organon and Co0 sites489 target enrollmentDecember 14, 2004

ConditionsBipolar Disorder

InterventionsAsenapine Olanzapine Placebo

Overview

Phase: Phase 3
Intervention: Asenapine
Conditions: Bipolar Disorder
Sponsor: Organon and Co
Enrollment: 489
Primary Endpoint: Change from Baseline to Day 21 on the Young Mania Rating Scale (YMRS) Total Score
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

Bipolar disorder is characterized by mood swings that range from high (manic) to low (depressed) states. Sometimes, symptoms of both depression and mania are present (mixed episodes). Asenapine is an investigational medication for the treatment of manic or mixed episodes of bipolar disorder. This is a 3-week study that will test the safety and efficacy of this medication. Participants will receive either asenapine, olanzapine (a medication that is already approved for the treatment of bipolar mania), or placebo (no active medication). Participants will be required to stay in the hospital for at least the first seven days of treatment. Participants who complete the 3 week study may be eligible to continue in extension studies for an additional 9 (study A7501006) to 49 (study A7501007) weeks.

Registry

clinicaltrials.gov

Start Date

December 14, 2004

End Date

April 28, 2006

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Organon and Co

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Have a Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnosis of bipolar I disorder, current episode manic or mixed.

Exclusion Criteria

•Participants with unstable medical conditions or clinically significant laboratory abnormalities or participants who are rapid cyclers (i.e., have had 4 or more (including current) mood episodes in the past 12 months); have any other psychiatric disorder other than bipolar I disorder as a primary diagnosis.

Arms & Interventions

Arm 1

Asenapine

Intervention: Asenapine

Arm 2

Olanzapine

Intervention: Olanzapine

Arm 3

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Change from Baseline to Day 21 on the Young Mania Rating Scale (YMRS) Total Score

Time Frame: Baseline to Day 21

Secondary Outcomes

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))