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

NCT01396291 | Completed Phase 3

• 2 other identifiers: P063842010-018671-20
• Study Type: interventional
• Target: 561
• Locations: 10 countries
• Sites: 80

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.

Conditions

Bipolar 1 Disorder

Outcome Measures

Primary Outcomes (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

Study Arms (2)

Asenapine

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

asenapine DRUG

asenapine, sublingual tablets, 5 to 10 mg twice per day (BID)

Also known as: SCH 900274, Saphris®, Sycrest®, Org 5222

Asenapine

placebo DRUG

asenapine-matched placebo, sublingual tablets, BID

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Forest Laboratories: lead

Study Sites (80)

Forest Investigative Site 3017

Anaheim, California, 92805, United States

Location

Forest Investigative Site 3019

Chino, California, 91710, United States

Location

Forest Investigative Site 3001

Escondido, California, 92025, United States

Location

Forest Investigative Site 3004

National City, California, 91950, United States

Location

Forest Investigative Site 3006

Oakland, California, 94612, United States

Location

Forest Investigative Site 3003

Orange, California, 92868, United States

Location

Forest Investigative Site 3007

Torrance, California, 90502, United States

Location

Forest Investigative Site 3042

Colorado Springs, Colorado, 80910, United States

Location

Forest Investigative Site 3012

Jacksonville, Florida, 32256, United States

Location

Forest Investigative Site 3040

Kissimmee, Florida, 34741, United States

Location

Forest Investigative Site 3031

Leesburg, Florida, 34748, United States

Location

Forest Investigative Site 3015

Miami, Florida, 33126, United States

Location

Forest Investigative Site 3010

Tampa, Florida, 33613, United States

Location

Forest Investigative Site 3039

Atlanta, Georgia, 30331, United States

Location

Forest Investigative Site 3032

Chicago, Illinois, 60640, United States

Location

Forest Investigative Site 3029

Schaumburg, Illinois, 60194, United States

Location

Forest Investigative Site 3021

Witchita, Kansas, 67207, United States

Location

Forest Investigative Site 3014

Gladstone, Missouri, 64118, United States

Location

Forest Investigative Site 3002

Albuquerque, New Mexico, 87108, United States

Location

Forest Investigative Site 3024

Elmsford, New York, 10523, United States

Location

Forest Investigative Site 3037

Avon Lake, Ohio, 44012, United States

Location

Forest Investigative Site 3041

Cincinnati, Ohio, 45219, United States

Location

Forest Investigative Site 3023

Oklahoma City, Oklahoma, 73112, United States

Location

Forest Investigative Site 3035

Oklahoma City, Oklahoma, 73116, United States

Location

Forest Investigative Site 3033

Memphis, Tennessee, 38119, United States

Location

Forest Investigative Site 3009

Houston, Texas, 77030, United States

Location

Forest Investigative Site 3020

Houston, Texas, 77090, United States

Location

Forest Investigative Site 3036

Irving, Texas, 75062, United States

Location

Forest Investigative Site 3027

Plano, Texas, 75093, United States

Location

Forest Investigative Site 3000

Wichita Falls, Texas, 76309, United States

Location

Forest Investigative Site 3105

Pleven, Pleven, 5800, Bulgaria

Location

Forest Investigative Site 3104

Sofia, Sofia-Grad, 1000, Bulgaria

Location

Forest Investigative Site 3100

Sofia, Sofia-Grad, 1202, Bulgaria

Location

Forest Investigative Site 3106

Sofia, Sofia-Grad, 1632, Bulgaria

Location

Forest Investigative Site 3101

Varna, Varna, 9010, Bulgaria

Location

Forest Investigative Site 3102

Burgas, 8000, Bulgaria

Location

Forest Investigative Site 3103

Varna, 9010, Bulgaria

Location

Forest Investigative Site 3153

Zagreb, City of Zagreb, 10000, Croatia

Location

Forest Investigative Site 3154

Zagreb, City of Zagreb, 10000, Croatia

Location

Forest Investigative Site 3152

Zagreb, City of Zagreb, 10090, Croatia

Location

Forest Investigative Site 3156

Rijeka, Rijeka, 51000, Croatia

Location

Forest Investigative Site 3308

Nashik, Andhra Pradesh, 422101, India

Location

Forest Investigative Site 3306

Ahmedabad, Gujarat, 380-006, India

Location

Forest Investigative Site 3305

Ahmedabad, Gujaratc, 380013, India

Location

Forest Investigative Site 3307

Nashik, Madhya Pradesh, 422101, India

Location

Forest Investigative Site 3302

Kanpur, Uttar Pradesh, 208005, India

Location

Forest Investigative Site 3303

Hyderabad, 500034, India

Location

Forest Investigative Site 3353

Cebu, Cebu, 6000, Philippines

Location

Forest Investigative Site 3352

Iloilo City, Iloilo, 5000, Philippines

Location

Forest Investigative Site 3356

Mandaluyong, Mandaluyong, 1553, Philippines

Location

Forest Investigative Site 3351

Manila, National Capital Region, 1000, Philippines

Location

Forest Investigative Site 3128

Bucharest, București, 011426, Romania

Location

Forest Investigative Site 3129

Bucharest, București, 041914, Romania

Location

Forest Investigative Site 3130

Bucharest, București, 041914, Romania

Location

Forest Investigative Site 3131

Târgovişte, Dâmbovița County, 130086, Romania

Location

Forest Investigative Site 3125

Iași, Iaşi, 700282, Romania

Location

Forest Investigative Site 3126

Targu Mureş, Mureș County, 540139, Romania

Location

Forest Investigative Site 3127

Arad, 310022, Romania

Location

Forest Investigative Site 3205

Kazan', Kazan, 420012, Russia

Location

Forest Investigative Site 3202

Moscow, Moscow, 107076, Russia

Location

Forest Investigative Site 3200

Moscow, Moscow, 115419, Russia

Location

Forest Investigative Site 3201

Saint Petersburg, Sankt-Peterburg, 190005, Russia

Location

Forest Investigative Site 3204

Smolensk, Smolensk Oblast, 214019, Russia

Location

Forest Investigative Site 3177

Belgrade, Belgrade, 11000, Serbia

Location

Forest Investigative Site 3176

Belgrade, Beograd, 11000, Serbia

Location

Forest Investigative Site 3179

Belgrade, Beograd, 11000, Serbia

Location

Forest Investigative Site 3182

Belgrade, Beograd, 11000, Serbia

Location

Forest Investigative Site 3178

Kragujevac, Kragujevac, 34000, Serbia

Location

Forest Investigative Site 3180

Kragujevac, Kragujevac, 34000, Serbia

Location

Forest Investigative Site 3182

Novi Kneževac, Vojvodina, 23330, Serbia

Location

Forest Investigative Site 3252

Korucuk, Adapazari, 54290, Turkey (Türkiye)

Location

Forest Investigative Site 3255

Ankara, Ankara, 06100, Turkey (Türkiye)

Location

Forest Investigative Site 3257

Diyarbakır, Diyarbakır, 21280, Turkey (Türkiye)

Location

Forest Investigative Site 3230

Chernihiv, Chernihiv Oblast, 14000, Ukraine

Location

Forest Investigative Site 3228

Kharkiv, Kharkivs’ka Oblast’, 61068, Ukraine

Location

Forest Investigative Site 3226

Kyiv, Kyiv Oblast, 01030, Ukraine

Location

Forest Investigative Site 3229

Kyiv, Kyiv Oblast, 254655, Ukraine

Location

Forest Investigative Site 3227

Luhansk, Luhansk Oblast, 91045, Ukraine

Location

Forest Investigative Site 3233

Kherson, 73488, Ukraine

Location

Forest Investigative Site 3232

Lviv, 79010, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 28946761 DERIVED

MeSH Terms

Interventions

asenapine

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2011
• First Posted: July 18, 2011
• Study Start: December 1, 2011
• Primary Completion: April 1, 2015
• Study Completion: June 1, 2015
• Last Updated: December 4, 2015

Record last verified: 2015-12

Locations

SE (7); IN (6); PH (4); CR (4); TU (3); UA (7); RU (5); US (30); RO (7); BU (7)