Bipolar and Schizophrenia Study for Teens

Lybalvi vs Zypexa

Study Specific Details:

Lybalvi vs Zyprexa – This is a double blind 52 week study in which subjects are placed on either Lybalvi or Zyprexa to evaluate weight gain. If the patient starts gaining weight, they have the option to roll into the open label Lybalvi study.
20 visits over a 52-week period.
Fasting required (at least 8 hours) prior to screening visit.
Participant are reimbursed $50 for their time and travel at the end of each completed visit.

Bipolar- Male or Female ages 10-17
Schizophrenia -Male or Female ages 13-17
DSM-5 primary diagnosis of Bipolar I or Schizophrenia as confirmed by K-SADS-PL.
Must have had an inadequate response to at least 1 antipsychotic.
ADHD treatments, SSRIs, SNRIs, and mood stabilizers are allowed if stable for at least 30 days.
Must be able to taper off prohibited conmeds before baseline.
Must be able to swallow the study medication.

DSM-5 diagnosis of schizoaffective disorder, current major depressive disorder that is untreated and/or unstable, or any other psychiatric condition that would interfere with participation in the study.
Subject has a BMI percentile >98th or <5th.
Treatment-naïve. Has to have had an inadequate response to an antipsychotic.
Topamax, Antipsychotics, MAOIs, Metformin or any other treatments for diabetes, Chantix, all prescription or over-the-counter (OTC) medications taken for the purpose of weight reduction, opioid agonist, opioid antagonist.
Severe head trauma w/ loss of consciousness w/in the past year prior to screening, or other clinically significant neurological condition w/in 12 months prior to screening.
Unable to swallow oral medication.
History of seizure disorder (except febrile).
Known risk for narrow-angle glaucoma.
Has joined a weight management program or had significant changes in diet or exercise regimen within 6 weeks prior to screening.
Has started a smoking cessation program w/in 6 months prior to screening or anticipates quitting smoking during study.
Positive for HEP B, C or HIV.
Meeting DSM-5 diagnosis for any substance-related disorder (except tobacco-related) within 3 months prior to screening.
Current suicidal or homicidal ideation, or suicidal behavior occurring in the past 12 months prior to screening.

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