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

Bipolar 1 Disorder Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01396291
• Other study ID #: P06384
• Secondary ID: 2010-018671-20
• Status: Completed
• Phase: Phase 3
• First received: July 14, 2011
• Last updated: December 3, 2015
• Start date: December 2011
• Est. completion date: June 2015

Study information

• Verified date: December 2015
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBulgaria: Bulgarian Drug AgencyCroatia: Agency for Medicinal Product and Medical DevicesIndia: Indian Council of Medical ResearchPhilippines: Philippine Council for Health Research and DevelopmentRomania: National Agency for Medicines and Medical DevicesRussia: Pharmacological Committee, Ministry of HealthSerbia: Medicines and Medical Devices AgencyTurkey: Ministry of HealthUkraine: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 561
• Est. completion date: June 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar 1 Disorder

Intervention

Drug:
• asenapine
asenapine, sublingual tablets, 5 to 10 mg twice per day (BID)
• placebo
asenapine-matched placebo, sublingual tablets, BID

Locations

Country	Name	City	State
Bulgaria	Forest Investigative Site 3102	Bourgas
Bulgaria	Forest Investigative Site 3105	Pleven
Bulgaria	Forest Investigative Site 3100	Sofia	Sofia-Grad
Bulgaria	Forest Investigative Site 3104	Sofia	Sofia-Grad
Bulgaria	Forest Investigative Site 3106	Sofia	Sofia-Grad
Bulgaria	Forest Investigative Site 3101	Varna
Bulgaria	Forest Investigative Site 3103	Varna
Croatia	Forest Investigative Site 3156	Rijeka
Croatia	Forest Investigative Site 3152	Zagreb	Grad Zagreb
Croatia	Forest Investigative Site 3153	Zagreb	Grad Zagreb
Croatia	Forest Investigative Site 3154	Zagreb	Grad Zagreb
India	Forest Investigative Site 3305	Ahmedabad	Gujaratc
India	Forest Investigative Site 3306	Ahmedabad	Gujarat
India	Forest Investigative Site 3303	Hyderabad
India	Forest Investigative Site 3302	Kanpur	Uttar Pradesh
India	Forest Investigative Site 3307	Nashik	Madhya Pradesh
India	Forest Investigative Site 3308	Nashik	Andhra Pradesh
Philippines	Forest Investigative Site 3353	Cebu
Philippines	Forest Investigative Site 3352	Iloilo
Philippines	Forest Investigative Site 3356	Mandaluyong
Philippines	Forest Investigative Site 3351	Manila	National Capital Region
Romania	Forest Investigative Site 3127	Arad
Romania	Forest Investigative Site 3128	Bucuresti
Romania	Forest Investigative Site 3129	Bucuresti
Romania	Forest Investigative Site 3130	Bucuresti
Romania	Forest Investigative Site 3125	Iasi
Romania	Forest Investigative Site 3131	Targoviste	Dâmbovita
Romania	Forest Investigative Site 3126	Targu Mures	Mures
Russian Federation	Forest Investigative Site 3205	Kazan
Russian Federation	Forest Investigative Site 3200	Moscow	Moskva
Russian Federation	Forest Investigative Site 3202	Moscow	Moskva
Russian Federation	Forest Investigative Site 3201	Saint Petersburg
Russian Federation	Forest Investigative Site 3204	Smolensk	Smolenskaya oblast
Serbia	Forest Investigative Site 3177	Belgrade
Serbia	Forest Investigative Site 3182	Belgrade	Beograd
Serbia	Forest Investigative Site 3176	Beograd
Serbia	Forest Investigative Site 3179	Beograd
Serbia	Forest Investigative Site 3178	Kragujevac
Serbia	Forest Investigative Site 3180	Kragujevac
Serbia	Forest Investigative Site 3182	Novi Knezevac	Vojvodina
Turkey	Forest Investigative Site 3255	Ankara
Turkey	Forest Investigative Site 3257	Diyarbakir
Turkey	Forest Investigative Site 3252	Korucuk	Adapazari
Ukraine	Forest Investigative Site 3230	Chernihiv	Chernihiv Oblast
Ukraine	Forest Investigative Site 3228	Kharkiv	Kharkiv Oblast
Ukraine	Forest Investigative Site 3233	Kherson
Ukraine	Forest Investigative Site 3226	Kyiv
Ukraine	Forest Investigative Site 3229	Kyiv
Ukraine	Forest Investigative Site 3227	Luhansk
Ukraine	Forest Investigative Site 3232	Lviv
United States	Forest Investigative Site 3002	Albuquerque	New Mexico
United States	Forest Investigative Site 3017	Anaheim	California
United States	Forest Investigative Site 3039	Atlanta	Georgia
United States	Forest Investigative Site 3037	Avon Lake	Ohio
United States	Forest Investigative Site 3032	Chicago	Illinois
United States	Forest Investigative Site 3019	Chino	California
United States	Forest Investigative Site 3041	Cincinnati	Ohio
United States	Forest Investigative Site 3042	Colorado Springs	Colorado
United States	Forest Investigative Site 3024	Elmsford	New York
United States	Forest Investigative Site 3001	Escondido	California
United States	Forest Investigative Site 3014	Gladstone	Missouri
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 3012	Jacksonville	Florida
United States	Forest Investigative Site 3040	Kissimmee	Florida
United States	Forest Investigative Site 3031	Leesburg,	Florida
United States	Forest Investigative Site 3033	Memphis	Tennessee
United States	Forest Investigative Site 3015	Miami	Florida
United States	Forest Investigative Site 3004	National City	California
United States	Forest Investigative Site 3006	Oakland	California
United States	Forest Investigative Site 3023	Oklahoma City	Oklahoma
United States	Forest Investigative Site 3035	Oklahoma City	Oklahoma
United States	Forest Investigative Site 3003	Orange	California
United States	Forest Investigative Site 3027	Plano	Texas
United States	Forest Investigative Site 3029	Schaumburg	Illinois
United States	Forest Investigative Site 3010	Tampa	Florida
United States	Forest Investigative Site 3007	Torrance	California
United States	Forest Investigative Site 3000	Wichita Falls	Texas
United States	Forest Investigative Site 3021	Witchita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Countries where clinical trial is conducted

United States,  Bulgaria,  Croatia,  India,  Philippines,  Romania,  Russian Federation,  Serbia,  Turkey,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No