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3-Week Study of Asenapine, Olanzapine and Placebo for Treatment of Bipolar Mania (P07008)

NCT00159744 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 488

Last updated 2024-08-15

No results posted yet for this study

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. Patients will receive either asenapine, olanzapine (a medication that is already approved for the treatment of bipolar mania), or placebo (no active medication). Patients will be required to stay in the hospital for at least the first seven days of treatment. Patients that complete the 3 week study may be eligible to continue in extension studies for an additional 9 (study A7501006) to 49 (study A7501007) weeks.

Conditions

Interventions

DRUG

Asenapine

Asenapine, 3 weeks

DRUG

Olanzapine

Olanzapine, 3 weeks

DRUG

Placebo

placebo, 3 weeks

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Organon and Co

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-11-30
Primary Completion
2006-04-29
Completion
2006-04-29

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00159744 on ClinicalTrials.gov