Efficacy and Safety of Asenapine in the Prevention of Recurrence of Mood Episodes in Participants With Bipolar 1 Disorder (P06384)
NCT ID: NCT01396291
Last Updated: 2015-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
561 participants
INTERVENTIONAL
2011-12-31
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
asenapine
asenapine, sublingual tablets, 5 to 10 mg twice per day (BID)
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.
placebo
asenapine-matched placebo, sublingual tablets, BID
Interventions
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asenapine
asenapine, sublingual tablets, 5 to 10 mg twice per day (BID)
placebo
asenapine-matched placebo, sublingual tablets, BID
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Forest Laboratories
INDUSTRY
Responsible Party
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Locations
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Forest Investigative Site 3017
Anaheim, California, United States
Forest Investigative Site 3019
Chino, California, United States
Forest Investigative Site 3001
Escondido, California, United States
Forest Investigative Site 3004
National City, California, United States
Forest Investigative Site 3006
Oakland, California, United States
Forest Investigative Site 3003
Orange, California, United States
Forest Investigative Site 3007
Torrance, California, United States
Forest Investigative Site 3042
Colorado Springs, Colorado, United States
Forest Investigative Site 3012
Jacksonville, Florida, United States
Forest Investigative Site 3040
Kissimmee, Florida, United States
Forest Investigative Site 3031
Leesburg, Florida, United States
Forest Investigative Site 3015
Miami, Florida, United States
Forest Investigative Site 3010
Tampa, Florida, United States
Forest Investigative Site 3039
Atlanta, Georgia, United States
Forest Investigative Site 3032
Chicago, Illinois, United States
Forest Investigative Site 3029
Schaumburg, Illinois, United States
Forest Investigative Site 3021
Witchita, Kansas, United States
Forest Investigative Site 3014
Gladstone, Missouri, United States
Forest Investigative Site 3002
Albuquerque, New Mexico, United States
Forest Investigative Site 3024
Elmsford, New York, United States
Forest Investigative Site 3037
Avon Lake, Ohio, United States
Forest Investigative Site 3041
Cincinnati, Ohio, United States
Forest Investigative Site 3023
Oklahoma City, Oklahoma, United States
Forest Investigative Site 3035
Oklahoma City, Oklahoma, United States
Forest Investigative Site 3033
Memphis, Tennessee, United States
Forest Investigative Site 3009
Houston, Texas, United States
Forest Investigative Site 3020
Houston, Texas, United States
Forest Investigative Site 3036
Irving, Texas, United States
Forest Investigative Site 3027
Plano, Texas, United States
Forest Investigative Site 3000
Wichita Falls, Texas, United States
Forest Investigative Site 3105
Pleven, Pleven, Bulgaria
Forest Investigative Site 3104
Sofia, Sofia-Grad, Bulgaria
Forest Investigative Site 3100
Sofia, Sofia-Grad, Bulgaria
Forest Investigative Site 3106
Sofia, Sofia-Grad, Bulgaria
Forest Investigative Site 3101
Varna, Varna, Bulgaria
Forest Investigative Site 3102
Burgas, , Bulgaria
Forest Investigative Site 3103
Varna, , Bulgaria
Forest Investigative Site 3153
Zagreb, City of Zagreb, Croatia
Forest Investigative Site 3154
Zagreb, City of Zagreb, Croatia
Forest Investigative Site 3152
Zagreb, City of Zagreb, Croatia
Forest Investigative Site 3156
Rijeka, Rijeka, Croatia
Forest Investigative Site 3308
Nashik, Andhra Pradesh, India
Forest Investigative Site 3306
Ahmedabad, Gujarat, India
Forest Investigative Site 3305
Ahmedabad, Gujaratc, India
Forest Investigative Site 3307
Nashik, Madhya Pradesh, India
Forest Investigative Site 3302
Kanpur, Uttar Pradesh, India
Forest Investigative Site 3303
Hyderabad, , India
Forest Investigative Site 3353
Cebu, Cebu, Philippines
Forest Investigative Site 3352
Iloilo City, Iloilo, Philippines
Forest Investigative Site 3356
Mandaluyong, Mandaluyong, Philippines
Forest Investigative Site 3351
Manila, National Capital Region, Philippines
Forest Investigative Site 3128
Bucharest, București, Romania
Forest Investigative Site 3129
Bucharest, București, Romania
Forest Investigative Site 3130
Bucharest, București, Romania
Forest Investigative Site 3131
Târgovişte, Dâmbovița County, Romania
Forest Investigative Site 3125
Iași, Iaşi, Romania
Forest Investigative Site 3126
Targu Mureş, Mureș County, Romania
Forest Investigative Site 3127
Arad, , Romania
Forest Investigative Site 3205
Kazan', Kazan, Russia
Forest Investigative Site 3202
Moscow, Moscow, Russia
Forest Investigative Site 3200
Moscow, Moscow, Russia
Forest Investigative Site 3201
Saint Petersburg, Sankt-Peterburg, Russia
Forest Investigative Site 3204
Smolensk, Smolensk Oblast, Russia
Forest Investigative Site 3177
Belgrade, Belgrade, Serbia
Forest Investigative Site 3176
Belgrade, Beograd, Serbia
Forest Investigative Site 3179
Belgrade, Beograd, Serbia
Forest Investigative Site 3182
Belgrade, Beograd, Serbia
Forest Investigative Site 3178
Kragujevac, Kragujevac, Serbia
Forest Investigative Site 3180
Kragujevac, Kragujevac, Serbia
Forest Investigative Site 3182
Novi Kneževac, Vojvodina, Serbia
Forest Investigative Site 3252
Korucuk, Adapazari, Turkey (Türkiye)
Forest Investigative Site 3255
Ankara, Ankara, Turkey (Türkiye)
Forest Investigative Site 3257
Diyarbakır, Diyarbakır, Turkey (Türkiye)
Forest Investigative Site 3230
Chernihiv, Chernihiv Oblast, Ukraine
Forest Investigative Site 3228
Kharkiv, Kharkivs’ka Oblast’, Ukraine
Forest Investigative Site 3226
Kyiv, Kyiv Oblast, Ukraine
Forest Investigative Site 3229
Kyiv, Kyiv Oblast, Ukraine
Forest Investigative Site 3227
Luhansk, Luhansk Oblast, Ukraine
Forest Investigative Site 3233
Kherson, , Ukraine
Forest Investigative Site 3232
Lviv, , Ukraine
Countries
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References
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Szegedi A, Durgam S, Mackle M, Yu SY, Wu X, Mathews M, Landbloom RP. Randomized, Double-Blind, Placebo-Controlled Trial of Asenapine Maintenance Therapy in Adults With an Acute Manic or Mixed Episode Associated With Bipolar I Disorder. Am J Psychiatry. 2018 Jan 1;175(1):71-79. doi: 10.1176/appi.ajp.2017.16040419. Epub 2017 Sep 26.
Other Identifiers
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2010-018671-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
P06384
Identifier Type: -
Identifier Source: org_study_id