Extension Study of Asenapine {P06107 (NCT01244815)} for Pediatric Bipolar Disorder (P05898 AM3)



Status:Completed
Conditions:Psychiatric, Bipolar Disorder
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:June 2011
End Date:August 2014
Contact:Toll Free Number
Phone:1-888-577-8839

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A 50-Week Open-Label, Flexible-Dose Trial of Asenapine Extension Treatment to P06107 in Pediatric Acute Manic or Mixed Episodes Associated With Bipolar I Disorder (Protocol No. P05898)


This study will investigate the safety and tolerability of a flexible dosing regimen of
asenapine for the long-term treatment of manic or mixed episodes associated with bipolar
disorder I in children and adolescents who completed study P06107 (NCT01244815).


Inclusion Criteria:

- Completed study P06107 and demonstrated acceptable degree of compliance with
medication, visits and other study requirements

- Must be male or a female who is not of childbearing potential or who is not pregnant,
not lactating, and is using a medically accepted method of contraception

- Must have a caregiver or responsible person living with the participant who agrees to
provide support to ensure compliance with treatment, visits, and protocol procedures

Exclusion Criteria:

- Positive pregnancy test or intention to become pregnant during the study

- At imminent risk of self-harm or harm to others

- Under involuntary inpatient commitment

- Known serological evidence of human immunodeficiency virus (HIV) antibody
We found this trial at
62
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1141
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Orlando, FL
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Amherst, NY
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Anaheim, CA
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Atlanta, GA
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Austin, TX
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Avon Lake, OH
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Bothell, WA
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Cambridge, MA
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900
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Canton, OH
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Charleston, South Carolina 29405
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Charleston, SC
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Charleston, South Carolina 29425
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Charleston, SC
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Charlottesville, Virginia 22903
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Charlottesville, VA
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725
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Cincinnati, OH
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899
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Cleveland, OH
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1176
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Coeur D'Alene, ID
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Colorado Springs, Colorado 80910
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Colorado Springs, CO
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Colton, CA
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Costa Mesa, CA
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348
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Dallas, TX
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359
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DeSoto, TX
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838
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Dothan, AL
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1127
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Escondido, CA
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574
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Flowood, MS
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1049
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Gainesville, FL
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898
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Garfield Heights, OH
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Glen Oaks, NY
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Hartford, CT
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569
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Houston, TX
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Houston, TX
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1152
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Irvine, CA
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Jacksonville Beach, Florida 32250
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Jacksonville Beach, FL
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Kirkland, WA
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Lake Charles, LA
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Lauderhill, FL
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Libertyville, IL
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219
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Lincoln, NE
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Little Rock, AR
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467
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Memphis, TN
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Mission Hills, California 91345
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Mission Hills, CA
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Murrieta, CA
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Naperville, IL
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154
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Oklahoma City, OK
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Oklahoma City, OK
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Oklahoma City, OK
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Orange City, FL
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Philadelphia, Pennsylvania 19139
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Philadelphia, PA
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Rochester, NY
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779
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Salt Lake City, UT
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San Diego, CA
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San Francisco, California 94133
1338
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San Francisco, CA
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Santa Ana, CA
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791
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Smyrna, GA
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St. Louis, MO
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Staten Island, NY
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Stonybrook, NY
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Tampa, FL
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574
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Terre Haute, IN
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151
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Tulsa, OK
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Washington, District of Columbia 20010
1127
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Washington,
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Washington, District of Columbia 20060
1127
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Washington,
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590
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Wharton, TX
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27
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Wichita, KS
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