Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Intra-Cellular Therapies, Inc.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female subjects of any race, ages 18-75 inclusive
Meets the Diagnostic and Statistical Manual of Mental Disorder, 5th Edition (DSM 5) criteria for Bipolar I or Bipolar II Disorder or MDD
The start of the current major depressive episode is at least 2 weeks but no more than 6 months prior to the Screening (Visit 1)
Has at least moderate severity of illness, as measured by a rater-administered MADRS total score ≥ 24 and corresponding to a CGI S score of ≥ 4 at Screening (Visit 1) and Baseline (Visit 2)
The patient meets the DSM-5 criteria for mixed-features specific to the Bipolar I or II diagnosis or MDD diagnosis
Current major depressive episode is causing clinically significant distress or impairment in social, occupational, or other important areas of functioning
Able to provide written informed consent
You may not be if
Any female subject who is pregnant or breast-feeding
Any subject judged to be medically inappropriate for study participation
The patient has a significant risk for suicidal behavior
The patient presents with a lifetime history of epilepsy, seizure or convulsion, or electroencephalogram with clinically significant abnormalities, delirium, dementia, amnestic, or other cognitive disorder or significant brain trauma
Clareo Health | Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder
