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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01349907
First received: May 5, 2011
Last updated: September 26, 2014
Last verified: September 2014

May 5, 2011
September 26, 2014
June 2011
September 2014   (final data collection date for primary outcome measure)
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 ]
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 (approximately 30 weeks) ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01349907 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Extension Study of Asenapine [P06107 (NCT01244815)]for Pediatric Bipolar Disorder (P05898)
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)

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).

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Bipolar Disorder
  • 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.
Experimental: Asenapine
Flexible-dose asenapine
Interventions:
  • Drug: Asenapine
  • Drug: Rescue medication
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
322
September 2014
September 2014   (final data collection date for primary outcome measure)

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
Both
10 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01349907
P05898
Yes
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP