Bipolar and Schizophrenia Study for Teens

Cariprazine (Vraylar)

$50 per completed visit

 

Study Specific Details:

  • Cariprazine- This is an open label study in which subjects are placed on Cariprazine.
  • 10 visits over a 26 week period.
  • Fasting required (at least 8 hours) for screening visit.
  • Participant are reimbursed $50 for their time and travel at the end of each completed visit.
  • Inclusion
  • Exclusion
  • Bipolar- Male or Female ages 10-17
  • Schizophrenia -Male or Female ages 13-17
  • DSM_5 primary diagnosis of bipolar I (most recent episode manic or mixed), or Schizophrenia as confirmed by K-SADS-PL.
  • Must be able to taper off prohibited conmeds prior to baseline.
  • ADHD treatments are allowed if stable for at least 30 days.
  • Benzodiazepine treatment (eg, lorazepam up to 2mg/d or equivalent) will be allowed if stable for 30 days prior to screening. 
  • Must be able to swallow the study medication.
  • DSM-5 diagnosis of schizoaffective disorder, schizophreniform, brief psychotic disorder, or psychotic disorder due to another medical condition.
  • Severe head trauma, history of seizures (exception of febrile), history of tumor of the central nervous system.
  • ECT within 1 month of screening, antipsychotic depot within 2 cycles of the respective dosing interval prior to screening.
  • Cataracts, clinically significant ocular trauma, history of ocular disease. 
  • Positive for HEPA B, C or HIV.
  • History of meeting DSM-5 diagnosis for any substance-related disorder (except caffeine- and tobacco-related) within 3 months prior to screening.
  • Current suicidal or homicidal ideation, history of suicide attempt in the past 6 months, history of serious homicidal risk or behavior that resulted in hospitalization or legal sentencing in the past 6 months.
  • Subject has an active seizure disorder. Past history of febrile seizure, during drug-induced seizure, or alcohol withdrawal seizure is not exclusionary.
  • Antipsychotics/Neuroleptics, anticonvulsants/mood stabilizers, MAO's, Lithium, Opiates, anxiolytics and hypnotics, dopamine-releasing drugs or dopamine agonists, psychotropic drugs not otherwise specified (including herbal products) are prohibited during the study.
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