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

Sponsor
Forest Laboratories (Industry)
Overall Status
Completed
CT.gov ID
NCT01396291
Collaborator
(none)
561
Enrollment
80
Locations
2
Arms
42
Duration (Months)
7
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
561 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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)
Study Start Date :
Dec 1, 2011
Actual Primary Completion Date :
Apr 1, 2015
Actual Study Completion Date :
Jun 1, 2015

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. The time (in days) to recurrence of any mood event during the double-blind treatment period [From Week 12 or 16 to Week 38 or 42]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Forest Investigative Site 3017 Anaheim California United States 92805
    2 Forest Investigative Site 3019 Chino California United States 91710
    3 Forest Investigative Site 3001 Escondido California United States 92025
    4 Forest Investigative Site 3004 National City California United States 91950
    5 Forest Investigative Site 3006 Oakland California United States 94612
    6 Forest Investigative Site 3003 Orange California United States 92868
    7 Forest Investigative Site 3007 Torrance California United States 90502
    8 Forest Investigative Site 3042 Colorado Springs Colorado United States 80910
    9 Forest Investigative Site 3012 Jacksonville Florida United States 32256
    10 Forest Investigative Site 3040 Kissimmee Florida United States 34741
    11 Forest Investigative Site 3031 Leesburg, Florida United States 34748
    12 Forest Investigative Site 3015 Miami Florida United States 33126
    13 Forest Investigative Site 3010 Tampa Florida United States 33613
    14 Forest Investigative Site 3039 Atlanta Georgia United States 30331
    15 Forest Investigative Site 3032 Chicago Illinois United States 60640
    16 Forest Investigative Site 3029 Schaumburg Illinois United States 60194
    17 Forest Investigative Site 3021 Witchita Kansas United States 67207
    18 Forest Investigative Site 3014 Gladstone Missouri United States 64118
    19 Forest Investigative Site 3002 Albuquerque New Mexico United States 87108
    20 Forest Investigative Site 3024 Elmsford New York United States 10523
    21 Forest Investigative Site 3037 Avon Lake Ohio United States 44012
    22 Forest Investigative Site 3041 Cincinnati Ohio United States 45219
    23 Forest Investigative Site 3023 Oklahoma City Oklahoma United States 73112
    24 Forest Investigative Site 3035 Oklahoma City Oklahoma United States 73116
    25 Forest Investigative Site 3033 Memphis Tennessee United States 38119
    26 Forest Investigative Site 3009 Houston Texas United States 77030
    27 Forest Investigative Site 3020 Houston Texas United States 77090
    28 Forest Investigative Site 3036 Irving Texas United States 75062
    29 Forest Investigative Site 3027 Plano Texas United States 75093
    30 Forest Investigative Site 3000 Wichita Falls Texas United States 76309
    31 Forest Investigative Site 3104 Sofia Sofia-Grad Bulgaria 1000
    32 Forest Investigative Site 3100 Sofia Sofia-Grad Bulgaria 1202
    33 Forest Investigative Site 3106 Sofia Sofia-Grad Bulgaria 1632
    34 Forest Investigative Site 3102 Bourgas Bulgaria 8000
    35 Forest Investigative Site 3105 Pleven Bulgaria 5800
    36 Forest Investigative Site 3101 Varna Bulgaria 9010
    37 Forest Investigative Site 3103 Varna Bulgaria 9010
    38 Forest Investigative Site 3153 Zagreb Grad Zagreb Croatia 10000
    39 Forest Investigative Site 3154 Zagreb Grad Zagreb Croatia 10000
    40 Forest Investigative Site 3152 Zagreb Grad Zagreb Croatia 10090
    41 Forest Investigative Site 3156 Rijeka Croatia 51000
    42 Forest Investigative Site 3308 Nashik Andhra Pradesh India 422101
    43 Forest Investigative Site 3305 Ahmedabad Gujaratc India 380013
    44 Forest Investigative Site 3306 Ahmedabad Gujarat India 380-006
    45 Forest Investigative Site 3307 Nashik Madhya Pradesh India 422101
    46 Forest Investigative Site 3302 Kanpur Uttar Pradesh India 208005
    47 Forest Investigative Site 3303 Hyderabad India 500034
    48 Forest Investigative Site 3351 Manila National Capital Region Philippines 1000
    49 Forest Investigative Site 3353 Cebu Philippines 6000
    50 Forest Investigative Site 3352 Iloilo Philippines 5000
    51 Forest Investigative Site 3356 Mandaluyong Philippines 1553
    52 Forest Investigative Site 3131 Targoviste Dâmboviţa Romania 130086
    53 Forest Investigative Site 3126 Targu Mureş Mureş Romania 540139
    54 Forest Investigative Site 3127 Arad Romania 310022
    55 Forest Investigative Site 3128 Bucureşti Romania 011426
    56 Forest Investigative Site 3129 Bucureşti Romania 041914
    57 Forest Investigative Site 3130 Bucureşti Romania 041914
    58 Forest Investigative Site 3125 Iaşi Romania 700282
    59 Forest Investigative Site 3202 Moscow Moskva Russian Federation 107076
    60 Forest Investigative Site 3200 Moscow Moskva Russian Federation 115419
    61 Forest Investigative Site 3204 Smolensk Smolenskaya oblast Russian Federation 214019
    62 Forest Investigative Site 3205 Kazan Russian Federation 420012
    63 Forest Investigative Site 3201 Saint Petersburg Russian Federation 190005
    64 Forest Investigative Site 3182 Belgrade Beograd Serbia 11000
    65 Forest Investigative Site 3182 Novi Knezevac Vojvodina Serbia 23330
    66 Forest Investigative Site 3177 Belgrade Serbia 11000
    67 Forest Investigative Site 3176 Beograd Serbia 11000
    68 Forest Investigative Site 3179 Beograd Serbia 11000
    69 Forest Investigative Site 3178 Kragujevac Serbia 34000
    70 Forest Investigative Site 3180 Kragujevac Serbia 34000
    71 Forest Investigative Site 3252 Korucuk Adapazari Turkey 54290
    72 Forest Investigative Site 3255 Ankara Turkey 06100
    73 Forest Investigative Site 3257 Diyarbakir Turkey 21280
    74 Forest Investigative Site 3230 Chernihiv Chernihiv Oblast Ukraine 14000
    75 Forest Investigative Site 3228 Kharkiv Kharkiv Oblast Ukraine 61068
    76 Forest Investigative Site 3233 Kherson Ukraine 73488
    77 Forest Investigative Site 3226 Kyiv Ukraine 01030
    78 Forest Investigative Site 3229 Kyiv Ukraine 254655
    79 Forest Investigative Site 3227 Luhansk Ukraine 91045
    80 Forest Investigative Site 3232 Lviv Ukraine 79010

    Sponsors and Collaborators

    • Forest Laboratories

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Forest Laboratories
    ClinicalTrials.gov Identifier:
    NCT01396291
    Other Study ID Numbers:
    • P06384
    • 2010-018671-20
    First Posted:
    Jul 18, 2011
    Last Update Posted:
    Dec 4, 2015
    Last Verified:
    Dec 1, 2015
    Additional relevant MeSH terms:
    Recurrence
    Asenapine

    Study Results

    No Results Posted as of Dec 4, 2015