Phase 3
N=322
Extension Study of Asenapine [P06107 (NCT01244815)] for Pediatric Bipolar Disorder (P05898)
Bipolar Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01349907 ↗Enrolled (actual)
322
Serious AEs
7.1%
Results posted
Mar 2015
Primary outcome: Primary: Number of Participants Who Experienced Clinical or Laboratory Adverse Events — 197; 74 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Asenapine (Drug); Rescue medication (Drug)
- Age
- Pediatric, Adult · 10+ yrs
- Sex
- All
- Sponsor
- Organon and Co
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced Clinical or Laboratory Adverse Events |
197; 74 | — |
| SECONDARY Change From Baseline in Young Mania Rating Scale (Y-MRS) Total Score |
-4.9; -13.0; -6.5; -15.2 | — |
| SECONDARY Percentage of Participants Who Were Y-MRS Total Score Remitters (Y-MRS ≤12) |
63.4; 83.8; 75.6; 90.0 | — |
| SECONDARY Percentage of Participants Who Were Y-MRS Total Score Responders |
37.8; 64.9; 53.5; 80.0 | — |
| SECONDARY Time to First Total Y-MRS 50% Response |
15.0; 49.0 | — |
| SECONDARY Time to Failure to Maintain Response in Y-MRS Total Score |
NA; 194.0 | — |
| SECONDARY Change From Baseline in Clinical Global Impression Scale for Assessing Overall Bipolar Illness (CGI-BP Overall) |
-0.9; -1.8; -1.2; -2.4 | — |
| SECONDARY Change From Baseline in Clinical Global Impression Scale for Assessing Depression (CGI-BP Depression) |
-0.5; -0.8; -0.4; -1.2 | — |
| SECONDARY Change From Baseline in Clinical Global Impression Scale for Assessing Mania (CGI-BP Mania) |
-1.0; -1.9; -1.2; -2.3 | — |
| SECONDARY Change From Baseline in Children's Depression Rating Scale, Revised (CDRS-R) Total Score |
-1.4; -5.4; -1.1; -4.3 | — |
| SECONDARY Percentage of CDRS-R Responders |
36.0; 56.8; 32.6; 65.0 | — |
| SECONDARY Percentage of Participants With Emergent Depression Based on CDRS-R |
2.7; 0.0; 2.3; 5.0 | — |
| SECONDARY Change From Baseline in Children's Global Assessment Scale (CGAS) |
9.7; 17.4; 13.1; 22.5 | — |
| SECONDARY Percentage of Participants With a CGAS Score of Equal or Greater Than 70 |
55.3; 73.0; 73.9; 85.0 | — |
| SECONDARY Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaires (PQ-LES-Q) Total Score |
1.0; 4.4; 0.5; 3.4 | — |
| SECONDARY Change From Baseline in PQ-LES-Q Overall Score |
0.1; 0.3; 0.4; 0.3 | — |
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.
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT01349907). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.