Status:
COMPLETED
Efficacy and Safety of Asenapine Treatment for Pediatric Bipolar Disorder (P06107 Has an Extension [P05898; NCT01349907])(P06107)
Lead Sponsor:
Organon and Co
Conditions:
Bipolar Disorder, Pediatric
Eligibility:
All Genders
10-17 years
Phase:
PHASE3
Brief Summary
Efficacy and safety of asenapine for the treatment of bipolar I disorder (manic or mixed episodes) will be evaluated in participants between 10 and 17 years old, who are either hospitalized or non-hos...
Detailed Description
Participants' Y-MRS total score at baseline will be subtracted from that at the Day 21 visit to determine the amount of change over time with treatment. The responses for the 3 different asenapine dos...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Participants who (or whose parent/legal representative) are able to give written informed consent.
- Participants must be 10 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 who are sexually active or become sexually active during the trial, and 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 possibly interfere with the study safety and efficacy evaluations.
Exclusion
Key Trial Info
Start Date :
June 16 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 17 2013
Estimated Enrollment :
404 Patients enrolled
Trial Details
Trial ID
NCT01244815
Start Date
June 16 2011
End Date
September 17 2013
Last Update
June 20 2024
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