Extension Study of Asenapine [P06107 (NCT01244815)] for Pediatric Bipolar Disorder (P05898) (ADDRESS-98)

Organon

Status and phase: Completed; Phase 3

Conditions: Bipolar Disorder

Treatments: Drug: Asenapine; Drug: Rescue medication

Study type: Interventional

Funder types: Industry

Identifiers

NCT01349907

P05898

MK-8274-022 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 322 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

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 and is not sexually active or is using a medically accepted method of contraception; or female who is not pregnant, or not lactating.
• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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322 participants in 2 patient groups

Asenapine/Asenapine

Experimental group

Description:

Participants treated with asenapine in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg twice per day (BID), then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.

Treatment:

Drug: Rescue medication

Drug: Asenapine

Placebo/Asenapine

Experimental group

Description:

Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.

Treatment:

Drug: Rescue medication

Drug: Asenapine