Efficacy and Safety of Asenapine Treatment for Pediatric Bipolar Disorder {P06107 Has an Extension (P05898; NCT01349907)}(P06107 AM4)

Participants' scores on the Y-MRS at baseline will be subtracted from those at Day 21 to
determine the amount of change over time with treatment. The responses for the 3 different
asenapine doses compared to placebo will be evaluated. The Y-MRS is an 11 item scale: seven
items ranked on scale from 0 to 4 and four items ranked 0 to 8 with a range of possible
total scores from 0 to 60.

Participants' overall score on the CGI-BP at Day 21 will be evaluated to determine the
amount of change over time with treatment. The responses for the 3 different asenapine doses
compared to placebo will be evaluated. CGI-BP is a single-item clinician-rated scale used to
assess the participant's global improvement compared to their status at baseline. Scores
range from not ill (1) to very severely ill (7).

The proportion of participants whose total Y-MRS score is decreased ≥50% from baseline at
Day 4, 7, 14 and 21. Results for the 3 different asenapine doses compared to placebo will be
evaluated.

The change from baseline at Day 21 in the Y-MRS total score will be compared among the
asenapine dose groups, and for each dose relative to placebo.

Participants' mania sub-score from the CGI-BP will be evaluated for each study visit (Days
4, 7, 14 and 21) to determine the amount of change over time with treatment. The responses
for the 3 different asenapine doses compared to placebo will be evaluated.

Participants' depression sub-score from the CGI-BP will evaluated at each study visit (Days
4, 7, 14 and 21) to determine the amount of change over time with treatment. The responses
for the 3 different asenapine doses compared to placebo will be evaluated.

Participants' CDRS-R at baseline will be subtracted from those at each study visit at which
this rating was measured (Days 7, 14 and 21) to determine the amount of change over time
with treatment. The responses for the 3 different asenapine doses compared to placebo will
be evaluated. The CDRS-R is a 17-item scale that assesses the severity and presence of
depressive symptoms: fourteen items are rated from 1 to 7 and three items are rated from 1
to 5; total scores range from 17 to 113.

Participants' CGAS at baseline will be subtracted from that at the Day 21 visit to determine
the amount of change over time with treatment. The responses for the 3 different asenapine
doses compared to placebo will be evaluated. The CGAS is a 100-point scale, with a possible
range of 1 to 100. Normal social functioning is defined as a CGAS total score of ≥70.

Participants' PQ-LES-Q total score at baseline will be subtracted from that at the Day 21
visit to determine the amount of change over time with treatment. The responses for the 3
different asenapine doses compared to placebo will be evaluated. The PQ-LES-Q is a 15-item
scale, with total score calculated as the sum of the first 14 items, with a range of 14 to
70. Each item is scored by the child from 1 to 5, with higher scores indicative of greater
enjoyment and satisfaction.

Participants' PQ-LES-Q overall score (i.e. item 15) at baseline will be subtracted from that
at the Day 21 visit to determine the amount of change over time with treatment. The
responses for the 3 different asenapine doses compared to placebo will be evaluated. The
PQ-LES-Q overall score is determined by the answer to item 15 on the questionnaire (range: 1
to 5).

Inclusion criteria:

- Participants who (or whose parent/legal representative) are able to give written
informed consent.

- Participants must be 10 years of age or older and 17 years of age or younger at the
time of treatment assignment (randomization).

- Participants must have a diagnosis of bipolar I disorder, confirmed by structured
interview at screening.

- Participants must not be pregnant or lactating, and those who are sexually active or
become sexually active during the trial, and of child-bearing potential, must be
using a medically accepted form of birth control.

- Participants will be required to have stopped taking certain psycho-active
medications prior to baseline.

- Participants must have a caregiver, or other responsible person living with them who
agrees to provide support to the participant to ensure study and procedure
compliance.

Exclusion criteria:

- Diagnosis of bipolar II disorder, or other form of bipolar or psychotic disorder.

- Known or suspected mental retardation.

- Substance abuse, or dependence, within the past 6 months.

- There is risk of self-harm or harm to others.

- There is a history of tardive dyskinesia or dystonia.

- Pregnancy or lactation during the study.

- History of seizure disorder.

- Participation in any other clinical trial at the same time.

- A family member who is part of the study staff or is directly involved with the
study.

- Other medical conditions determined by the study staff to be unsafe for study
participation.