Clinical trial NCT01396291: Efficacy and Safety of Asenapine in the Prevention of Recurrence of Mood Episodes in Participants With Bipolar 1 Disorder (P06384)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar 1 Disorder
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2011-07-18
Enrollment: 561
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The time (in days) to recurrence of any mood event during the double-blind treatment period
timeFrame: From Week 12 or 16 to Week 38 or 42
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Forest Investigative Site 3017
state: California
city: Chino
country: United States
facility: Forest Investigative Site 3019
state: California
city: Escondido
country: United States
facility: Forest Investigative Site 3001
state: California
city: National City
country: United States
facility: Forest Investigative Site 3004
state: California
city: Oakland
country: United States
facility: Forest Investigative Site 3006
state: California
city: Orange
country: United States
facility: Forest Investigative Site 3003
state: California
city: Torrance
country: United States
facility: Forest Investigative Site 3007
state: California
city: Colorado Springs
country: United States
facility: Forest Investigative Site 3042
state: Colorado
city: Jacksonville
country: United States
facility: Forest Investigative Site 3012
state: Florida
city: Kissimmee
country: United States
facility: Forest Investigative Site 3040
state: Florida
city: Leesburg,
country: United States
facility: Forest Investigative Site 3031
state: Florida
city: Miami
country: United States
facility: Forest Investigative Site 3015
state: Florida
city: Tampa
country: United States
facility: Forest Investigative Site 3010
state: Florida
city: Atlanta
country: United States
facility: Forest Investigative Site 3039
state: Georgia
city: Chicago
country: United States
facility: Forest Investigative Site 3032
state: Illinois
city: Schaumburg
country: United States
facility: Forest Investigative Site 3029
state: Illinois
city: Witchita
country: United States
facility: Forest Investigative Site 3021
state: Kansas
city: Gladstone
country: United States
facility: Forest Investigative Site 3014
state: Missouri
city: Albuquerque
country: United States
facility: Forest Investigative Site 3002
state: New Mexico
city: Elmsford
country: United States
facility: Forest Investigative Site 3024
state: New York
city: Avon Lake
country: United States
facility: Forest Investigative Site 3037
state: Ohio
city: Cincinnati
country: United States
facility: Forest Investigative Site 3041
state: Ohio
city: Oklahoma City
country: United States
facility: Forest Investigative Site 3023
state: Oklahoma
city: Oklahoma City
country: United States
facility: Forest Investigative Site 3035
state: Oklahoma
city: Memphis
country: United States
facility: Forest Investigative Site 3033
state: Tennessee
city: Houston
country: United States
facility: Forest Investigative Site 3009
state: Texas
city: Houston
country: United States
facility: Forest Investigative Site 3020
state: Texas
city: Irving
country: United States
facility: Forest Investigative Site 3036
state: Texas
city: Plano
country: United States
facility: Forest Investigative Site 3027
state: Texas
city: Wichita Falls
country: United States
facility: Forest Investigative Site 3000
state: Texas
city: Sofia
country: Bulgaria
facility: Forest Investigative Site 3104
state: Sofia-Grad
city: Sofia
country: Bulgaria
facility: Forest Investigative Site 3100
state: Sofia-Grad
city: Sofia
country: Bulgaria
facility: Forest Investigative Site 3106
state: Sofia-Grad
city: Bourgas
country: Bulgaria
facility: Forest Investigative Site 3102
city: Pleven
country: Bulgaria
facility: Forest Investigative Site 3105
city: Varna
country: Bulgaria
facility: Forest Investigative Site 3101
city: Varna
country: Bulgaria
facility: Forest Investigative Site 3103
city: Zagreb
country: Croatia
facility: Forest Investigative Site 3153
state: Grad Zagreb
city: Zagreb
country: Croatia
facility: Forest Investigative Site 3154
state: Grad Zagreb
city: Zagreb
country: Croatia
facility: Forest Investigative Site 3152
state: Grad Zagreb
city: Rijeka
country: Croatia
facility: Forest Investigative Site 3156
city: Nashik
country: India
facility: Forest Investigative Site 3308
state: Andhra Pradesh
city: Ahmedabad
country: India
facility: Forest Investigative Site 3305
state: Gujaratc
city: Ahmedabad
country: India
facility: Forest Investigative Site 3306
state: Gujarat
city: Nashik
country: India
facility: Forest Investigative Site 3307
state: Madhya Pradesh
city: Kanpur
country: India
facility: Forest Investigative Site 3302
state: Uttar Pradesh
city: Hyderabad
country: India
facility: Forest Investigative Site 3303
city: Manila
country: Philippines
facility: Forest Investigative Site 3351
state: National Capital Region
city: Cebu
country: Philippines
facility: Forest Investigative Site 3353
city: Iloilo
country: Philippines
facility: Forest Investigative Site 3352
city: Mandaluyong
country: Philippines
facility: Forest Investigative Site 3356
city: Targoviste
country: Romania
facility: Forest Investigative Site 3131
state: Dâmboviţa
city: Targu Mureş
country: Romania
facility: Forest Investigative Site 3126
state: Mureş
city: Arad
country: Romania
facility: Forest Investigative Site 3127
city: Bucureşti
country: Romania
facility: Forest Investigative Site 3128
city: Bucureşti
country: Romania
facility: Forest Investigative Site 3129
city: Bucureşti
country: Romania
facility: Forest Investigative Site 3130
city: Iaşi
country: Romania
facility: Forest Investigative Site 3125
city: Moscow
country: Russian Federation
facility: Forest Investigative Site 3202
state: Moskva
city: Moscow
country: Russian Federation
facility: Forest Investigative Site 3200
state: Moskva
city: Smolensk
country: Russian Federation
facility: Forest Investigative Site 3204
state: Smolenskaya oblast
city: Kazan
country: Russian Federation
facility: Forest Investigative Site 3205
city: Saint Petersburg
country: Russian Federation
facility: Forest Investigative Site 3201
city: Belgrade
country: Serbia
facility: Forest Investigative Site 3182
state: Beograd
city: Novi Knezevac
country: Serbia
facility: Forest Investigative Site 3182
state: Vojvodina
city: Belgrade
country: Serbia
facility: Forest Investigative Site 3177
city: Beograd
country: Serbia
facility: Forest Investigative Site 3176
city: Beograd
country: Serbia
facility: Forest Investigative Site 3179
city: Kragujevac
country: Serbia
facility: Forest Investigative Site 3178
city: Kragujevac
country: Serbia
facility: Forest Investigative Site 3180
city: Korucuk
country: Turkey
facility: Forest Investigative Site 3252
state: Adapazari
city: Ankara
country: Turkey
facility: Forest Investigative Site 3255
city: Diyarbakir
country: Turkey
facility: Forest Investigative Site 3257
city: Chernihiv
country: Ukraine
facility: Forest Investigative Site 3230
state: Chernihiv Oblast
city: Kharkiv
country: Ukraine
facility: Forest Investigative Site 3228
state: Kharkiv Oblast
city: Kherson
country: Ukraine
facility: Forest Investigative Site 3233
city: Kyiv
country: Ukraine
facility: Forest Investigative Site 3226
city: Kyiv
country: Ukraine
facility: Forest Investigative Site 3229
city: Luhansk
country: Ukraine
facility: Forest Investigative Site 3227
city: Lviv
country: Ukraine
facility: Forest Investigative Site 3232
Study officials:
References:
citation: 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.