Adult Bipolar I or II with Depressive Episode

Adult Bipolar I or II with Depressive Episode

$50 per completed visit

 

Study Specific Details:

 
  • ABBV-932 vs Placebo – This is a double blind study in which subjects are randomly placed on  either ABBV-932 or Placebo as treatment for depressive symptoms.  Dr. Handal will be able to find out what medication the subject is on in case of emergency.
  • This is a 6-week treatment period.   
  • Participants are reimbursed $75 for their time and travel at the end of each completed visit.
  • Inclusion
  • Exclusion
  • Individuals 19 to 65 years of age, inclusive, at time of consent
  • BMI greater or equal to ≥18 to ≤40kg
  • Cognitive behavioral therapy is allowed as long as it was initiated at least 12 weeks prior to screening and there are no changes during the study.  
  • No history of psychiatric hospitalization in the past 3 months prior to screening. 
  • No lifetime history of schizophrenia, other psychotic disorders, dissociative disorders, or neurocognitive disorders. 
  • Substance use disorder (except nicotine) in the past 6 months.  
  •  Suicidal ideation the past 6 months 
  • Suicidal behavior in the past 12 months
  • History of seizures (except a single febrile seizure of childhood), stroke, significant head injury, central nervous system tumor
  • Positive for hepatitis B, C or HIV. 
  • History of tardive dyskinesia or neuroleptic-malignant syndrome. 
  • Received treatment with vagus nerve stimulation, TMS, esketamine within 6 months of screening. 
  • Antipsychotics, antidepressants, anticonvulsants, mood stabilizers, sedative/hypnotic medication, herb, or over-the-counter medication with psychoactive potential.
  • History of clozapine treatment.
  • Depot antipsychotic in the past 12 weeks prior to screening. 
  • Intolerance or hypersensitivity to antipsychotics.  
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