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Efficacy and Safety of 3-Week Fixed-Dose Asenapine Treatment in Pediatric Acute Manic or Mixed Episodes Associated With Bipolar I Disorder (Protocol No. P06107)

This study is currently Recruiting

October 2011 By Schering-Plough

First Recieved on November 18, 2010

Last Updated on October 31, 2011

Sponsor: Schering-Plough
Collaborators:
Information provided by: Schering-Plough
Identifier: NCT01244815

Purpose

Efficacy and safety of asenapine for the treatment of bipolar I disorder (manic or mixed episodes) will be evaluated in participants between 12 and 17 years old, who are either hospitalized or non-hospitalized. In this 3-weeks, double-blind, parallel design trial, patients eligible for participation will be randomized to receive one out of three fixed dose levels of asenapine, or placebo. Trial medication and placebo are provided as identical-looking sublingual tablets; concurrent use of psychotropics is prohibited, except use of short-acting benzodiazepines and psychostimulants approved for the treatment of attention deficit hyperactivity disorder (ADHD). Main treatment effect is measured using the Young Mania Rating Scale (Y-MRS) and safety is evaluated using the recordings of adverse events, routine blood panels, physical examinations (including vital signs), and electrocardiograms. Patients who complete the double blind trial may be offered to continue (open-label) treatment with asenapine for an extended period of time. Follow-up information on safety parameters will be collected in all patients within 30 days following treatment discontinuation.

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

Eligibility

Ages Eligible for Study:12 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
Criteria

Inclusion criteria: - Participants who (or whose parent/legal representative) are able to give written informed consent. - Participants must be 12 years of age or older and 17 years of age or younger at the time of treatment assignment (randomization). - Participants must have a diagnosis of bipolar I disorder, confirmed by structured interview at screening. - Participants must not be pregnant or lactating, and those of child-bearing potential must be using a medically accepted form of birth control. - Participants will be required to have stopped taking certain psycho-active medications prior to baseline. - Participants must have a caregiver, or other responsible person living with them who agrees to provide support to the participant to ensure study and procedure compliance. Exclusion criteria: - Diagnosis of bipolar II disorder, or other form of bipolar or psychotic disorder. - Known or suspected mental retardation. - Substance abuse, or dependence, within the past 6 months. - There is risk of self-harm or harm to others. - There is a history of tardive dyskinesia or dystonia. - Pregnancy or lactation during the study. - History of seizure disorder. - Participation in any other clinical trial at the same time. - A family member who is part of the study staff or is directly involved with the study. - Other medical conditions determined by the study staff to be unsafe for study participation.

Investigators

Locations

  • Investigational Site 18

    Dothan, Alabama 36303 United States

  • Investigational Site 6

    Scottsdale, Arizona 85251 United States

  • Investigational Site 11

    Little Rock, Arkansas 72223 United States

  • Investigational Site 86

    Little Rock, Arkansas 72211 United States

  • Investigational Site 13

    Anaheim, California 92805 United States

  • Investigational Site 85

    Colton, California 92324 United States

  • Investigational Site 61

    Escondido, California 92025 United States

  • Investigational Site 35

    San Diego, California 92108 United States

  • Investigational Site 96

    Santa Ana, California 92701 United States

  • Investigational Site 83

    Temecula, California 92562-7285 United States

  • Investigational Site 67

    Colorado Springs, Colorado 80904 United States

  • Investigational Site 48

    Gainesville, Florida 32607 United States

  • Investigational Site 25

    Jacksonville Beach, Florida 32250 United States

  • Investigational Site 14

    Miami, Florida 33180 United States

  • Investigational Site 51

    North Miami, Florida 33161 United States

  • Investigational Site 56

    Orange City, Florida 32763 United States

  • Investigational Site 26

    Orlando, Florida 32839 United States

  • Investigational Site 45

    Atlanta, Georgia 30308 United States

  • Investigational Site 3

    Smyrna, Georgia 30080-6315 United States

  • Investigational Site 17

    Libertyville, Illinois 60048 United States

  • Investigational Site 19

    Terre Haute, Indiana 47802 United States

  • Investigational Site 58

    Lake Charles, Louisiana 70629 United States

  • Investigational Site 52

    Clinton Township, Michigan 48038 United States

  • Investigational Site 81

    Creve Coeur, Missouri 63141 United States

  • Investigational Site 71

    Lincoln, Nebraska 68510 United States

  • Investigational Site 7

    Amherst, New York 14226 United States

  • Investigational Site 1

    Avon Lake, Ohio 44012 United States

  • Investigational Site 32

    Canton, Ohio 44718 United States

  • Investigational Site 44

    Garfield Heights, Ohio 44125 United States

  • Investigational Site 70

    Oklahoma City, Oklahoma 73103 United States

  • Investigational Site 23

    Oklahoma City, Oklahoma 73116 United States

  • Investigational Site 50

    Oklahoma City, Oklahoma 73112 United States

  • Investigational Site 31

    Philadelphia, Pennsylvania 19139 United States

  • Investigational Site 12

    Charleston, South Carolina 29405 United States

  • Investigational Site 54

    Memphis, Tennessee 38119 United States

  • Investigational Site 37

    Dallas, Texas 75234 United States

  • Investigational Site 53

    DeSoto, Texas 75115 United States

  • Investigational Site 16

    Houston, Texas 77090 United States

  • Investigational Site 24

    Lake JAckson, Texas 77566 United States

  • Investigational Site 41

    Wharton, Texas 77488 United States

  • Investigational Site 63

    Salt Lake City, Utah 84107 United States

  • Investigational Site 39

    Bothell, Washington 98011 United States

  • Investigational Site 29

    Kirkland, Washington 98033 United States

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