Bipolar with Depression for Teens

Caplyta vs Placebo

Study Specific Details:

This is a 8-week, multi center, randomized, double-blind trial of Caplyta treatment in teens with Bipolar.
9 visits over a 3 month study period.
Participant are reimbursed $100 for their time and travel at the end of each completed visit.

Male or Female ages 13-17.
Patient has a lifetime history of at least one manic or hypomanic episode.
Patient's current depressive episode is at least 4 weeks in but less than 12 months in duration.
BMI is greater than the 5th percentile for age and gender.
Able to swallow capsules.
Allowed Medications: ADHD medications. Melatonin up to 5 mg and Benadryl up to 50 mg is permitted PRN for insomnia. Lorazepam up to 2 mg for intolerable anxiety or agitation.
Patient does not need to fast prior to screening.

Patient has a primary psychiatric diagnosis other than Bipolar I or II with ADHD being the only exception.
Intellectual disability.
Patient has been hospitalized as a result of a manic episode in the past 30 days before randomization.
Suicidal ideation in the past 6 months before screening.
Patient has had more than 1 suicidal attempt in the past 2 years before screening.
History of seizures, with the exception of febrile seizures.
History of significant head trauma or any condition that predisposes to seizures.
Positive for Hepatitis B, C or HIV.
The patient has had exposure to Caplyta within 3 months of baseline.
Antidepressants, antipsychotics, and mood stabilizers are not allowed.

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