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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
561

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 14, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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