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

Phase 3

Completed

• Conditions: Bipolar 1 Disorder
• Interventions: Drug: placebo; Drug: asenapine

• Registration Number: NCT01396291
• Lead Sponsor: Forest Laboratories

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-14
• Study First Submitted QC: 2011-07-15
• Study First Posted: 2011-07-18
• Study Start: 2011-12
• Primary Completion: 2015-04
• Study Completion: 2015-06
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-03
• Last Update Posted: 2015-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 561

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	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.
Asenapine	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (79)

Forest Investigative Site 3106; 🇧🇬 Sofia, Sofia-Grad, Bulgaria

Forest Investigative Site 3103; 🇧🇬 Varna, Bulgaria

Forest Investigative Site 3154; 🇭🇷 Zagreb, Grad Zagreb, Croatia

Forest Investigative Site 3152; 🇭🇷 Zagreb, Grad Zagreb, Croatia

Forest Investigative Site 3101; 🇧🇬 Varna, Bulgaria

Forest Investigative Site 3021; 🇺🇸 Witchita, Kansas, United States

Forest Investigative Site 3010; 🇺🇸 Tampa, Florida, United States

Forest Investigative Site 3105; 🇧🇬 Pleven, Bulgaria

Forest Investigative Site 3156; 🇭🇷 Rijeka, Croatia

Forest Investigative Site 3037; 🇺🇸 Avon Lake, Ohio, United States

Forest Investigative Site 3100; 🇧🇬 Sofia, Sofia-Grad, Bulgaria

Forest Investigative Site 3002; 🇺🇸 Albuquerque, New Mexico, United States

Forest Investigative Site 3035; 🇺🇸 Oklahoma City, Oklahoma, United States

Forest Investigative Site 3029; 🇺🇸 Schaumburg, Illinois, United States

Forest Investigative Site 3000; 🇺🇸 Wichita Falls, Texas, United States

Forest Investigative Site 3306; 🇮🇳 Ahmedabad, Gujarat, India

Forest Investigative Site 3023; 🇺🇸 Oklahoma City, Oklahoma, United States

Forest Investigative Site 3033; 🇺🇸 Memphis, Tennessee, United States

Forest Investigative Site 3104; 🇧🇬 Sofia, Sofia-Grad, Bulgaria

Forest Investigative Site 3176; 🇷🇸 Beograd, Serbia

Forest Investigative Site 3252; 🇹🇷 Korucuk, Adapazari, Turkey

Forest Investigative Site 3200; 🇷🇺 Moscow, Moskva, Russian Federation

Forest Investigative Site 3226; 🇺🇦 Kyiv, Ukraine

Forest Investigative Site 3126; 🇷🇴 Targu Mureş, Mureş, Romania

Forest Investigative Site 3233; 🇺🇦 Kherson, Ukraine

Forest Investigative Site 3232; 🇺🇦 Lviv, Ukraine

Forest Investigative Site 3257; 🇹🇷 Diyarbakir, Turkey

Forest Investigative Site 3205; 🇷🇺 Kazan, Russian Federation

Forest Investigative Site 3255; 🇹🇷 Ankara, Turkey

Forest Investigative Site 3179; 🇷🇸 Beograd, Serbia

Forest Investigative Site 3230; 🇺🇦 Chernihiv, Chernihiv Oblast, Ukraine

Forest Investigative Site 3204; 🇷🇺 Smolensk, Smolenskaya oblast, Russian Federation

Forest Investigative Site 3007; 🇺🇸 Torrance, California, United States

Forest Investigative Site 3040; 🇺🇸 Kissimmee, Florida, United States

Forest Investigative Site 3015; 🇺🇸 Miami, Florida, United States

Forest Investigative Site 3039; 🇺🇸 Atlanta, Georgia, United States

Forest Investigative Site 3041; 🇺🇸 Cincinnati, Ohio, United States

Forest Investigative Site 3009; 🇺🇸 Houston, Texas, United States

Forest Investigative Site 3017; 🇺🇸 Anaheim, California, United States

Forest Investigative Site 3004; 🇺🇸 National City, California, United States

Forest Investigative Site 3003; 🇺🇸 Orange, California, United States

Forest Investigative Site 3001; 🇺🇸 Escondido, California, United States

Forest Investigative Site 3006; 🇺🇸 Oakland, California, United States

Forest Investigative Site 3042; 🇺🇸 Colorado Springs, Colorado, United States

Forest Investigative Site 3102; 🇧🇬 Bourgas, Bulgaria

Forest Investigative Site 3031; 🇺🇸 Leesburg,, Florida, United States

Forest Investigative Site 3032; 🇺🇸 Chicago, Illinois, United States

Forest Investigative Site 3014; 🇺🇸 Gladstone, Missouri, United States

Forest Investigative Site 3020; 🇺🇸 Houston, Texas, United States

Forest Investigative Site 3027; 🇺🇸 Plano, Texas, United States

Forest Investigative Site 3305; 🇮🇳 Ahmedabad, Gujaratc, India

Forest Investigative Site 3308; 🇮🇳 Nashik, Andhra Pradesh, India

Forest Investigative Site 3353; 🇵🇭 Cebu, Philippines

Forest Investigative Site 3129; 🇷🇴 Bucureşti, Romania

Forest Investigative Site 3356; 🇵🇭 Mandaluyong, Philippines

Forest Investigative Site 3128; 🇷🇴 Bucureşti, Romania

Forest Investigative Site 3130; 🇷🇴 Bucureşti, Romania

Forest Investigative Site 3202; 🇷🇺 Moscow, Moskva, Russian Federation

Forest Investigative Site 3201; 🇷🇺 Saint Petersburg, Russian Federation

Forest Investigative Site 3178; 🇷🇸 Kragujevac, Serbia

Forest Investigative Site 3228; 🇺🇦 Kharkiv, Kharkiv Oblast, Ukraine

Forest Investigative Site 3024; 🇺🇸 Elmsford, New York, United States

Forest Investigative Site 3019; 🇺🇸 Chino, California, United States

Forest Investigative Site 3012; 🇺🇸 Jacksonville, Florida, United States

Forest Investigative Site 3036; 🇺🇸 Irving, Texas, United States

Forest Investigative Site 3127; 🇷🇴 Arad, Romania

Forest Investigative Site 3125; 🇷🇴 Iaşi, Romania

Forest Investigative Site 3177; 🇷🇸 Belgrade, Serbia

Forest Investigative Site 3180; 🇷🇸 Kragujevac, Serbia

Forest Investigative Site 3302; 🇮🇳 Kanpur, Uttar Pradesh, India

Forest Investigative Site 3307; 🇮🇳 Nashik, Madhya Pradesh, India

Forest Investigative Site 3352; 🇵🇭 Iloilo, Philippines

Forest Investigative Site 3182; 🇷🇸 Novi Knezevac, Vojvodina, Serbia

Forest Investigative Site 3303; 🇮🇳 Hyderabad, India

Forest Investigative Site 3351; 🇵🇭 Manila, National Capital Region, Philippines

Forest Investigative Site 3153; 🇭🇷 Zagreb, Grad Zagreb, Croatia

Forest Investigative Site 3131; 🇷🇴 Targoviste, Dâmboviţa, Romania

Forest Investigative Site 3229; 🇺🇦 Kyiv, Ukraine

Forest Investigative Site 3227; 🇺🇦 Luhansk, Ukraine