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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