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Efficacy and Safety of Asenapine in the Prevention of Recurrence of Mood Episodes in Participants With Bipolar 1 Disorder (P06384)

NCT01396291 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 561

Last updated 2015-12-04

No results posted yet for this study

Summary

This study is being done to evaluate the efficacy and safety of asenapine as compared to placebo in preventing the recurrence of mood episodes after stabilization of an acute/manic mixed episode in participants with Bipolar 1 Disorder. After a Screening Period, each participant will receive open-label asenapine and matching placebo for 12 to 16 weeks. Participants who meet stabilization criteria may then be randomized into one of the two study arms (asenapine or matching placebo) to receive double-blind treatment for up to an additional 26-weeks.

Conditions

  • Bipolar 1 Disorder

Interventions

DRUG

asenapine

asenapine, sublingual tablets, 5 to 10 mg twice per day (BID)

DRUG

placebo

asenapine-matched placebo, sublingual tablets, BID

Sponsors & Collaborators

  • Forest Laboratories

    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
2011-12-31
Primary Completion
2015-04-30
Completion
2015-06-30

Countries

  • United States
  • Bulgaria
  • Croatia
  • India
  • Philippines
  • Romania
  • Russia
  • Serbia
  • Turkey (Türkiye)
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs

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 NCT01396291 on ClinicalTrials.gov