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

NCT01349907 | Completed Phase 3 Results DMC

• 2 other identifiers: P05898MK-8274-022
• Study Type: interventional
• Target: 322
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Experienced Clinical or Laboratory Adverse Events

  A clinical or laboratory adverse event is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.

  Baseline (Day 1) to 30 days after the last dose of study drug (up to approximately 54 weeks)

Secondary Outcomes (15)

• Change From Baseline in Young Mania Rating Scale (Y-MRS) Total Score

  Baseline, Day 182 and Day 350

• Percentage of Participants Who Were Y-MRS Total Score Remitters (Y-MRS ≤12)

  Up to Day 350

• Percentage of Participants Who Were Y-MRS Total Score Responders

  Up to Day 350

• Time to First Total Y-MRS 50% Response

  Up to Day 350

• Time to Failure to Maintain Response in Y-MRS Total Score

  Up to Day 350

Study Arms (2)

Asenapine/Asenapine

EXPERIMENTAL

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.

Drug: Asenapine; Drug: Rescue medication

Placebo/Asenapine

EXPERIMENTAL

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.

Drug: Asenapine; Drug: Rescue medication

Interventions

Asenapine DRUG

One flavored asenapine sublingual tablet (containing either 2.5, 5 or 10 mg asenapine) twice daily (BID), starting at 2.5 mg on Day 1 for three consecutive days. Normally on Day 4, the dose will increase to 5 mg BID beginning with the evening dose. Normally on Day 7, the dose will increase to 10 mg BID beginning with the evening dose. The dose may be up-titrated earlier than Days 4 and 7 at the investigator's discretion. Beginning on Day 8 (or after at least 1 day on 10 mg BID), asenapine dosing will be flexible (2.5, 5, or 10 mg BID) until up to Week 50.

Also known as: SCH 900274, ORG 5222

Asenapine/Asenapine; Placebo/Asenapine

Rescue medication DRUG

For participants whose symptoms worsen or are not adequately controlled on assigned treatment, rescue medication may be administered during the trial in the following circumstances. For the control of agitation, anxiety, insomnia, restlessness, or akathisia and extrapyramidal symptoms (EPS) some benzodiazepines (i.e., lorazepam \[up to 4 mg/day\] or an equivalent dose of short-acting benzodiazepines) and EPS medications (i.e., anticholinergics) are allowed. Benadryl (diphenhydramine) and beta blockers are also permitted, provided that they are not taken within 8 hours of efficacy assessments.

Asenapine/Asenapine; Placebo/Asenapine

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (2)

• Findling RL, Landbloom RL, Szegedi A, Koppenhaver J, Braat S, Zhu Q, Mackle M, Chang K, Mathews M. Asenapine for the Acute Treatment of Pediatric Manic or Mixed Episode of Bipolar I Disorder. J Am Acad Child Adolesc Psychiatry. 2015 Dec;54(12):1032-41. doi: 10.1016/j.jaac.2015.09.007. Epub 2015 Oct 24.

  PMID: 26598478 RESULT

• Findling RL, Landbloom RL, Mackle M, Wu X, Snow-Adami L, Chang K, Durgam S. Long-term Safety of Asenapine in Pediatric Patients Diagnosed With Bipolar I Disorder: A 50-Week Open-Label, Flexible-Dose Trial. Paediatr Drugs. 2016 Oct;18(5):367-78. doi: 10.1007/s40272-016-0184-2.

  PMID: 27461426 DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Interventions

asenapine

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2011
• First Posted: May 9, 2011
• Study Start: June 16, 2011
• Primary Completion: September 5, 2014
• Study Completion: September 5, 2014
• Last Updated: May 22, 2024
• Results First Posted: March 9, 2015

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share