Clinical trial NCT01349907: Extension Study of Asenapine [P06107 (NCT01244815)] for Pediatric Bipolar Disorder (P05898)
Official title: A 50-Week Open-Label, Flexible-Dose Trial of Asenapine Extension Treatment to P06107 in Pediatric Subjects With Acute Manic or Mixed Episodes Associated With Bipolar I Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar Disorder
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2011-05-09
Enrollment: 322
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Participants Who Experienced Clinical or Laboratory Adverse Events
timeFrame: Baseline (Day 1) to 30 days after the last dose of study drug (up to approximately 54 weeks)
Secondary outcomes:
measure: Change From Baseline in Young Mania Rating Scale (Y-MRS) Total Score
timeFrame: Baseline, Day 182 and Day 350
measure: Percentage of Participants Who Were Y-MRS Total Score Remitters (Y-MRS ≤12)
timeFrame: Up to Day 350
measure: Percentage of Participants Who Were Y-MRS Total Score Responders
timeFrame: Up to Day 350
measure: Time to First Total Y-MRS 50% Response
timeFrame: Up to Day 350
measure: Time to Failure to Maintain Response in Y-MRS Total Score
timeFrame: Up to Day 350
measure: Change From Baseline in Clinical Global Impression Scale for Assessing Overall Bipolar Illness (CGI-BP Overall)
timeFrame: Baseline, Day 182 and Day 350
measure: Change From Baseline in Clinical Global Impression Scale for Assessing Depression (CGI-BP Depression)
timeFrame: Baseline, Day 182 and Day 350
measure: Change From Baseline in Clinical Global Impression Scale for Assessing Mania (CGI-BP Mania)
timeFrame: Baseline, Day 182 and Day 350
measure: Change From Baseline in Children's Depression Rating Scale, Revised (CDRS-R) Total Score
timeFrame: Baseline, Day 182 and Day 350
measure: Percentage of CDRS-R Responders
timeFrame: Up to Day 350
measure: Percentage of Participants With Emergent Depression Based on CDRS-R
timeFrame: Up to Day 350
measure: Change From Baseline in Children's Global Assessment Scale (CGAS)
timeFrame: Baseline, Day 182 and Day 350
measure: Percentage of Participants With a CGAS Score of Equal or Greater Than 70
timeFrame: Up to Day 350
measure: Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaires (PQ-LES-Q) Total Score
timeFrame: Baseline, Day 182 and Day 350
measure: Change From Baseline in PQ-LES-Q Overall Score
timeFrame: Baseline, Day 182 and Day 350
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.