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

Organon

Status and phase: Completed; Phase 3

Conditions: Bipolar Disorder

Treatments: Drug: Asenapine; Drug: Olanzapine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00159796

P07009

A7501005 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 489 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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489 participants in 3 patient groups, including a placebo group

Arm 1

Experimental group

Description:

Asenapine

Treatment:

Drug: Asenapine

Arm 2

Active Comparator group

Description:

Olanzapine

Treatment:

Drug: Olanzapine

Arm 3

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo