Depression or Bi-Polar Disorder - Oceanside CA

Summary:

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:  

• Screening Period: 2 weeks  

• Treatment Period: 6 weeks 

• Follow-up Period: 2 weeks 

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: 

1. Between the ages of 18 and 75 years 

1. Has a (BMI) of 19–35 kg/m2 

1. Meets the Diagnostic and Statistical Manual of Mental Disorder, 5th Edition (DSM-5) criteria for MDD, Bipolar I or Bipolar II Disorder  

1. Must agree to use highly effective methods of birth control  

Exclusion: 

1.  THC (ok at screening only)  ALCOHOL abuse

1. Has been hospitalized for mania associated with Bipolar I Disorder within 30 days of screening 

1.  Has received electroconvulsive therapy 

1. The patient has had at least 6 major depressive, manic, hypomanic, or mixed episodes during the previous year. 

1. The patient has a positive test for drugs of abuse or alcohol at Screening (Visit 1) 

1. Tests positive for HIV, Hep B, Hep C. 

1.  The patient is unable to be safely discontinued from current antidepressant medication, mood stabilizers, anticholinergics, or other psychotropic medications. 

1. 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 

Qualified Participants May Receive:

- Compensation after every completed appointment and reimbursement up to $53 for gas.

- Investigational medication or placebo at no cost.