Efficacy and Safety of Asenapine Treatment for Pediatric Bipolar Disorder (P06107 Has an Extension [P05898; NCT01349907])(P06107)

• Status: Completed
• Trial end date: 2013-09-17
• Target enrollment: 0
• Participant gender: All

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-hospitalized. In this 3-weeks, double-blind, parallel design trial, eligible participants will be randomized to receive one out of three fixed dose levels of asenapine, or placebo. The study primary hypothesis is that at least one asenapine dose is superior to placebo as measured by the change from baseline to Day 21 in Young Mania Rating Scale (Y-MRS) total score. 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 Y-MRS and safety is evaluated using the recordings of adverse events, routine blood panels, physical examinations (including vital signs), and electrocardiograms. Participants 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 participants within 30 days following treatment discontinuation.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Asenapine

Criteria

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.