Bipolar and Schizophrenia Study for Teens
$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.
- 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.
Questions? Give Us A Call!
Want to learn more about Harmonex Neuroscience Research?