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

December 3, 2015 updated by: Forest Laboratories

A Double-Blind, Placebo-Controlled Trial of Asenapine in the Prevention of Recurrence of a Mood Episode After Stabilization of an Acute Manic/Mixed Episode in Subjects With Bipolar 1 Disorder (Phase 3B, Protocol P06384)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

561

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Bourgas, Bulgaria, 8000
        • Forest Investigative Site 3102
      • Pleven, Bulgaria, 5800
        • Forest Investigative Site 3105
      • Varna, Bulgaria, 9010
        • Forest Investigative Site 3101
      • Varna, Bulgaria, 9010
        • Forest Investigative Site 3103
    • Sofia-Grad
      • Sofia, Sofia-Grad, Bulgaria, 1000
        • Forest Investigative Site 3104
      • Sofia, Sofia-Grad, Bulgaria, 1202
        • Forest Investigative Site 3100
      • Sofia, Sofia-Grad, Bulgaria, 1632
        • Forest Investigative Site 3106
  • Croatia
      • Rijeka, Croatia, 51000
        • Forest Investigative Site 3156
    • Grad Zagreb
      • Zagreb, Grad Zagreb, Croatia, 10000
        • Forest Investigative Site 3153
      • Zagreb, Grad Zagreb, Croatia, 10000
        • Forest Investigative Site 3154
      • Zagreb, Grad Zagreb, Croatia, 10090
        • Forest Investigative Site 3152
  • India
      • Hyderabad, India, 500034
        • Forest Investigative Site 3303
    • Andhra Pradesh
      • Nashik, Andhra Pradesh, India, 422101
        • Forest Investigative Site 3308
    • Gujarat
      • Ahmedabad, Gujarat, India, 380-006
        • Forest Investigative Site 3306
    • Gujaratc
      • Ahmedabad, Gujaratc, India, 380013
        • Forest Investigative Site 3305
    • Madhya Pradesh
      • Nashik, Madhya Pradesh, India, 422101
        • Forest Investigative Site 3307
    • Uttar Pradesh
      • Kanpur, Uttar Pradesh, India, 208005
        • Forest Investigative Site 3302
  • Philippines
      • Cebu, Philippines, 6000
        • Forest Investigative Site 3353
      • Iloilo, Philippines, 5000
        • Forest Investigative Site 3352
      • Mandaluyong, Philippines, 1553
        • Forest Investigative Site 3356
    • National Capital Region
      • Manila, National Capital Region, Philippines, 1000
        • Forest Investigative Site 3351
  • Romania
      • Arad, Romania, 310022
        • Forest Investigative Site 3127
      • Bucureşti, Romania, 011426
        • Forest Investigative Site 3128
      • Bucureşti, Romania, 041914
        • Forest Investigative Site 3129
      • Bucureşti, Romania, 041914
        • Forest Investigative Site 3130
      • Iaşi, Romania, 700282
        • Forest Investigative Site 3125
    • Dâmboviţa
      • Targoviste, Dâmboviţa, Romania, 130086
        • Forest Investigative Site 3131
    • Mureş
      • Targu Mureş, Mureş, Romania, 540139
        • Forest Investigative Site 3126
  • Russian Federation
      • Kazan, Russian Federation, 420012
        • Forest Investigative Site 3205
      • Saint Petersburg, Russian Federation, 190005
        • Forest Investigative Site 3201
    • Moskva
      • Moscow, Moskva, Russian Federation, 107076
        • Forest Investigative Site 3202
      • Moscow, Moskva, Russian Federation, 115419
        • Forest Investigative Site 3200
    • Smolenskaya oblast
      • Smolensk, Smolenskaya oblast, Russian Federation, 214019
        • Forest Investigative Site 3204
  • Serbia
      • Belgrade, Serbia, 11000
        • Forest Investigative Site 3177
      • Beograd, Serbia, 11000
        • Forest Investigative Site 3176
      • Beograd, Serbia, 11000
        • Forest Investigative Site 3179
      • Kragujevac, Serbia, 34000
        • Forest Investigative Site 3178
      • Kragujevac, Serbia, 34000
        • Forest Investigative Site 3180
    • Beograd
      • Belgrade, Beograd, Serbia, 11000
        • Forest Investigative Site 3182
    • Vojvodina
      • Novi Knezevac, Vojvodina, Serbia, 23330
        • Forest Investigative Site 3182
  • Turkey
      • Ankara, Turkey, 06100
        • Forest Investigative Site 3255
      • Diyarbakir, Turkey, 21280
        • Forest Investigative Site 3257
    • Adapazari
      • Korucuk, Adapazari, Turkey, 54290
        • Forest Investigative Site 3252
  • Ukraine
      • Kherson, Ukraine, 73488
        • Forest Investigative Site 3233
      • Kyiv, Ukraine, 01030
        • Forest Investigative Site 3226
      • Kyiv, Ukraine, 254655
        • Forest Investigative Site 3229
      • Luhansk, Ukraine, 91045
        • Forest Investigative Site 3227
      • Lviv, Ukraine, 79010
        • Forest Investigative Site 3232
    • Chernihiv Oblast
      • Chernihiv, Chernihiv Oblast, Ukraine, 14000
        • Forest Investigative Site 3230
    • Kharkiv Oblast
      • Kharkiv, Kharkiv Oblast, Ukraine, 61068
        • Forest Investigative Site 3228
  • United States
    • California
      • Anaheim, California, United States, 92805
        • Forest Investigative Site 3017
      • Chino, California, United States, 91710
        • Forest Investigative Site 3019
      • Escondido, California, United States, 92025
        • Forest Investigative Site 3001
      • National City, California, United States, 91950
        • Forest Investigative Site 3004
      • Oakland, California, United States, 94612
        • Forest Investigative Site 3006
      • Orange, California, United States, 92868
        • Forest Investigative Site 3003
      • Torrance, California, United States, 90502
        • Forest Investigative Site 3007
    • Colorado
      • Colorado Springs, Colorado, United States, 80910
        • Forest Investigative Site 3042
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Forest Investigative Site 3012
      • Kissimmee, Florida, United States, 34741
        • Forest Investigative Site 3040
      • Leesburg,, Florida, United States, 34748
        • Forest Investigative Site 3031
      • Miami, Florida, United States, 33126
        • Forest Investigative Site 3015
      • Tampa, Florida, United States, 33613
        • Forest Investigative Site 3010
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Forest Investigative Site 3039
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Forest Investigative Site 3032
      • Schaumburg, Illinois, United States, 60194
        • Forest Investigative Site 3029
    • Kansas
      • Witchita, Kansas, United States, 67207
        • Forest Investigative Site 3021
    • Missouri
      • Gladstone, Missouri, United States, 64118
        • Forest Investigative Site 3014
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • Forest Investigative Site 3002
    • New York
      • Elmsford, New York, United States, 10523
        • Forest Investigative Site 3024
    • Ohio
      • Avon Lake, Ohio, United States, 44012
        • Forest Investigative Site 3037
      • Cincinnati, Ohio, United States, 45219
        • Forest Investigative Site 3041
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Forest Investigative Site 3023
      • Oklahoma City, Oklahoma, United States, 73116
        • Forest Investigative Site 3035
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Forest Investigative Site 3033
    • Texas
      • Houston, Texas, United States, 77030
        • Forest Investigative Site 3009
      • Houston, Texas, United States, 77090
        • Forest Investigative Site 3020
      • Irving, Texas, United States, 75062
        • Forest Investigative Site 3036
      • Plano, Texas, United States, 75093
        • Forest Investigative Site 3027
      • Wichita Falls, Texas, United States, 76309
        • Forest Investigative Site 3000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Male, or a female who is not of child-bearing potential or who is non-pregnant, non-lactating, and is using a medically accepted method of contraception.
  • Each participant must be willing and able to provide written informed consent.
  • Each participant must have an identified external contact person or an identified responsible person.
  • Current diagnosis of Bipolar 1 Disorder, and a current manic (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision [DSM-IV-TR^TM] code 296.4x) or mixed (DSM-IV code 296.6x) episode as determined by a structured clinical interview (Mini International Neuropsychiatric Interview [MINI]) at Screening.
  • Each participant must be confirmed to be experiencing an acute manic or mixed bipolar 1 episode.

Exclusion criteria:

  • Uncontrolled, unstable clinically significant medical condition.
  • Clinically significant abnormal laboratory, vital sign, physical examination, or electrocardiogram findings at Screening.
  • Current primary Axis I disorder other than bipolar 1 disorder.
  • Meets the current DSM-IV-TR^TM criteria for substance abuse or dependence (excluding nicotine).
  • Imminent risk of self-harm or harm to others.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Asenapine
All study participants will first receive open-label asenapine and placebo for 12 to 16 weeks before being randomized. After randomization, participants will receive asenapine or placebo (this is the double-blind period) for up to 26 weeks.
Drug: asenapine
asenapine, sublingual tablets, 5 to 10 mg twice per day (BID)
Other Names:
  • SCH 900274, Saphris®, Sycrest®, Org 5222
Placebo Comparator: Placebo
All study participants will first receive open-label asenapine and placebo for 12 to 16 weeks before being randomized. After randomization, participants will receive asenapine or placebo (this is the double-blind period) for up to 26 weeks.
Drug: placebo
asenapine-matched placebo, sublingual tablets, BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The time (in days) to recurrence of any mood event during the double-blind treatment period
Time Frame: From Week 12 or 16 to Week 38 or 42
From Week 12 or 16 to Week 38 or 42

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Forest Laboratories

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

July 14, 2011

First Submitted That Met QC Criteria

July 15, 2011

First Posted (Estimate)

July 18, 2011

Study Record Updates

Last Update Posted (Estimate)

December 4, 2015

Last Update Submitted That Met QC Criteria

December 3, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P06384
  • 2010-018671-20 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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