ITI-007-403 Study Summary
A Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Lumateperone: Monotherapy in the Treatment of Patients with Major Depressive Episodes or have Associated depressive episodes with Bipolar I or Bipolar II Disorder (Bipolar Depression)
Study Design:
Total # of visits: 9
Compensation: 50$ per completed visit, 25$ per completed unscheduled visit, 53$ for travel expenses
Study Drug: Lumateperone, 42 Mg, taken orally 1x daily
Inclusion:
Between the ages of 18 and 75 years
Has a (BMI) of 19–35 kg/m2
Meets the Diagnostic and Statistical Manual of Mental Disorder, 5th Edition (DSM-5) criteria for MDD, Bipolar I or Bipolar II Disorder
Must agree to use highly effective methods of birth control
Exclusion:
THC (ok at screening only) ALCOHOL abuse
Has been hospitalized for mania associated with Bipolar I Disorder within 30 days of screening
Has received electroconvulsive therapy
The patient has had at least 6 major depressive, manic, hypomanic, or mixed episodes during the previous year.
The patient has a positive test for drugs of abuse or alcohol at Screening (Visit 1)
Tests positive for HIV, Hep B, Hep C.
The patient is unable to be safely discontinued from current antidepressant medication, mood stabilizers, anticholinergics, or other psychotropic medications.
Has a psychiatric diagnosis other than bipolar disorder, including
a. Schizophrenia or other psychotic disorder
b. Anxiety disorders such as panic disorder, GAD, or PTSD as a primary diagnosis (however, anxiety symptoms may be allowed, if secondary to bipolar disorder, provided these symptoms do not require current treatment)
c. Feeding or eating disorder
d. Obsessive compulsive disorder
e. Personality disorder
f. Moderate or severe substance use disorder (including for cannabis);
g. Any other psychiatric condition (other than bipolar disorder) that has been the
main focus of treatment within 12 months of screening,
GASTRIC BYPASS IS EXCLUSIONARY PER CRITERIA 16