Conditions: Schizophrenia Bipolar I Disorder
Keywords: asenapine pediatric schizophrenia bipolar I disorder
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 30
Healthy volunteers: no

Brief summary:
This study is an open label, sequential-group, two site, multiple dose escalating study of sublingual administered asenapine in a pediatric population with schizophrenia or bipolar I disorder; in one study cohort (3a) participants with other conditions treatable with chronic antipsychotic medication can also be enrolled. Participants will receive a single sublingual placebo dose on Day -1, followed by multiple sublingual doses of asenapine twice daily (b.i.d.) for 6 days (Cohorts 1 and 2), 7 days (Cohort 3b-d), or 11 days (Cohort 3a), and a final once daily administration on Day 7 (Cohorts 1 and 2), Day 8 (Cohort 3b-d) or Day 12 (Cohort 3a).

Detailed description:

Arms:
arm 1: Participants 10 or 11 years of age arm 2: Participants 10 or 11 years of age arm 3: Cohort 3a: Participants 10 or 11 years of age

Cohort 3b: Participants 12 or 13 years of age

Cohort 3c: Participants 14 or 15 years of age

Cohort 3d: Participants 16 or 17 years of age

Interventions: intervention 1: Asenapine 2.5 mg intervention 2: Asenapine 5 mg intervention 3: Asenapine 10 mg
Intervention descriptions: intervention 1: Asenapine tablet, sublingually (SL), 2.5 mg b.i.d. on Days 1-6 and one 2.5 mg tablet, SL, on Day 7. intervention 2: Asenapine tablet, SL, 5 mg b.i.d. on Days 1-6 and one 5 mg tablet, SL, on Day 7. intervention 3: Asenapine tablets, SL, in a rising dose schedule to 10 mg b.i.d. (with a single 10 mg dose on final day). For Cohorts 3b, 3c and 3d, rising dose schedule begins with asenapine 5 mg b.i.d. on Day 1 and dosing occurs through Day 8. For Cohort 3a, rising dose schedule begins with asenapine 2.5 mg b.i.d. on Day 1 and dosing occurs through Day 12.

Protocol document: