3-week Study of Asenapine, Olanzapine and Placebo for Treatment of Bipolar Mania (P07009)

Organon and Co489 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

489

Conditions

Bipolar Disorder

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

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

Change from Baseline to Day 21 in the Clinical Global Impression Scale for use in Bipolar Disorder (CGI-BP) Severity of Mania

Time frame: Baseline to Day 21

Change from Baseline to Day 21 in the Positive and Negative Symptom Scale (PANSS) Total Score

Time frame: Baseline to Day 21

Change from Baseline to Day 21 in Montgomery Asberg Depression Rating Scale (MADRS) Total Score

Time frame: Baseline to Day 21

Readiness for Discharge Questionnaire (RDQ)

Time frame: Baseline to Day 21

Change from Baseline to Day 21 in Central Nervous System (CNS) Vital Signs

Time frame: Baseline to Day 21

Change from Baseline to Day 21 in Short Form-36 (SF-36) - Physical Component Summary Scores

Time frame: Baseline to Day 21

Change from Baseline to Day 21 in the Severity of Extrapyramidal Symptoms (EPS)

Time frame: Baseline to Day 21

Concomitant Medication Usage

Time frame: Up to Day 21

Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame: Up to 30 days after last dose (Up to approximately 51 days)

Change from Baseline to Each Time Point in YMRS Total Score

Time frame: Days 2, 4, 7, 14, and 21

Change from Baseline to Day 21 in the CGI-BP Severity of Depression

Time frame: Baseline to Day 21

Change from Baseline to Day 21 in the CGI-BP Severity of Overall Bipolar Illness

Time frame: Baseline to Day 21

Change from Baseline to Day 21 in SF-36 - Mental Component Summary Scores

Time frame: Baseline to Day 21

Treatment Satisfaction Questionnaire for Medicine (TSQM) Overall Impact Domain Score at Day 21

Time frame: Day 21

Mean Change from Baseline for Vital Signs

Time frame: Baseline up to Day 21

Change from Baseline to Day 21 in Body Weight

Time frame: Baseline to Day 21

Summary of Post-Baseline Markedly Abnormal Biochemistry Laboratory Changes/Values

Time frame: Up to Day 21

Summary of Post-Baseline Markedly Abnormal Endocrinology/Miscellaneous Laboratory Changes/Values

Time frame: Up to Day 21

Summary of Post-Baseline Markedly Abnormal Metabolic Chemistry Laboratory Changes/Values

Time frame: Up to Day 21

Summary of Post-Baseline Markedly Abnormal Hematology Laboratory Values

Time frame: Up to Day 21

Pharmacokinetics - Plasma asenapine concentrations

Time frame: Day 1 (pre-dose), 7, 14 and 21 (or endpoint)