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9 Week Extension Study of Asenapine and Olanzapine in Treatment of Mania (P07007)(COMPLETED)

NCT00143182 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 504

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. Patients who completed the 3 week trial (A7601004 or A7501005) continued on the same treatment that they received in the short term study: asenapine or olanzapine (a medication already approved for the treatment of bipolar mania) for 9 additional weeks. The short term studies (A7501004 and A7501005) were not unblinded until the 9 week extension study was unblinded. Patients treated with placebo in the 3 week short term study were crossed over and treated with Asenapine in the 9 week extension study. Patients who complete the 9 week extension study were eligible to continue in another extension (A7501007) study for an additional 40 weeks.

Conditions

Interventions

DRUG

Asenapine

Asenapine , 9 weeks

DRUG

Olanzapine

Olanzapine, 9 weeks

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Organon and Co

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-07
Primary Completion
2006-06-28
Completion
2006-06-28

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Entities

Drugs
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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 NCT00143182 on ClinicalTrials.gov