Extension Study of Asenapine {P06107 (NCT01244815)} for Pediatric Bipolar Disorder (P05898 AM3) - Full Text View

Purpose

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:

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: Asenapine

U.S. FDA Resources

Further study details as provided by Merck:

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 ]

Estimated Enrollment:	280
Study Start Date:	June 2011
Estimated Study Completion Date:	August 2014
Estimated Primary Completion Date:	August 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.

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.

Eligibility

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01349907

Show 67 Study Locations

Sponsors and Collaborators

Merck

More Information

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT01349907 History of Changes
Other Study ID Numbers:	P05898
Study First Received:	May 5, 2011
Last Updated:	January 4, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Asenapine
Antipsychotic Agents
Tranquilizing Agents

Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 22, 2013

Extension Study of Asenapine {P06107 (NCT01244815)} for Pediatric Bipolar Disorder (P05898 AM3) (ADDRESS-98)