Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: May 5, 2011
Last updated: October 21, 2014
Last verified: October 2014

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 (NCT01244815).

Condition Intervention Phase
Bipolar Disorder
Drug: Asenapine
Drug: Rescue medication
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 50-Week Open-Label, Flexible-Dose Trial of Asenapine Extension Treatment to P06107 in Pediatric Acute Manic or Mixed Episodes Associated With Bipolar I Disorder (Protocol No. P05898)

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of participants who experience clinical or laboratory adverse events [ Time Frame: Baseline (Day 1) to 30 days after the last dose of study drug (up to approximately 54 weeks) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline in Young Mania Rating Scale (Y-MRS) total score [ Time Frame: Up to Week 50 ] [ Designated as safety issue: No ]
  • Proportion of Y-MRS total score remitters (Y-MRS ≤12) [ Time Frame: Up to Week 50 ] [ Designated as safety issue: No ]
  • Proportion of Y-MRS total score responders ≥50% [ Time Frame: Up to Week 50 ] [ Designated as safety issue: No ]
  • Time to first total Y-MRS 50% response [ Time Frame: Up to Week 50 ] [ Designated as safety issue: No ]
  • Time to failure to maintain effect [ Time Frame: Up to Week 50 ] [ Designated as safety issue: No ]
  • Change from baseline in Clinical Global Impression Scale for use in Bipolar Illness (CGI-BP) overall, CGI-BP depression, and CGI-BP mania [ Time Frame: Up to Week 50 ] [ Designated as safety issue: No ]
  • Change from baseline in Children's Depression Rating Scale, Revised (CDRS-R) total score [ Time Frame: Up to Week 50 ] [ Designated as safety issue: No ]
  • Proportion of CDRS-R responders [ Time Frame: Up to Week 50 ] [ Designated as safety issue: No ]
  • Proportion of participants with emergent depression based on CDRS-R [ Time Frame: Up to Week 50 ] [ Designated as safety issue: No ]
  • Change from baseline in Children's Global Assessment Scale (CGAS) [ Time Frame: Up to Week 50 ] [ Designated as safety issue: No ]
  • Proportion of participants with CGAS total score >=70 [ Time Frame: Up to Week 50 ] [ Designated as safety issue: No ]
  • Change from baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaires (PQ-LES-Q) total score [ Time Frame: Up to Week 50 ] [ Designated as safety issue: No ]
  • Change from baseline in PQ-LES-Q overall score [ Time Frame: Up to Week 50 ] [ Designated as safety issue: No ]

Enrollment: 322
Study Start Date: June 2011
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Asenapine
Flexible-dose asenapine
Drug: Asenapine
One flavored asenapine sublingual tablet 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.
Other Name: SCH 900274, ORG 5222
Drug: Rescue medication
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.


Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 or who is not pregnant, not lactating, and is using a medically accepted method of contraception
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT01349907     History of Changes
Other Study ID Numbers: P05898
Study First Received: May 5, 2011
Last Updated: October 21, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Pathologic Processes
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents processed this record on February 25, 2015