Major Depression for Adults

Investigational Medication vs Placebo Plus Antidepressant

$50 per completed visit

 

Study Specific Details:

  • This is a phase 3, randomized, double-blind study comparing investigational medication plus antidepressant vs placebo plus antidepressant in adults with Major Depressive Disorder.
  • 11 visits over 2 1/2 month study period.
  • Participant are reimbursed $50 for their time and travel at the end of each completed visit.
  • Inclusion
  • Exclusion
  • Male or Female ages 19-64.
  • Currently meets diagnosis of MDD as diagnosed by SCID-5-CT, with symptoms that have been present for at least 4 week period.
  • Cognitive Behavioral Therapy is permitted as long as patient has been receiving therapy on a regular schedule for at least 60 days and maintains the schedule for the duration of the study.
  • CBT for insomnia is permitted as long as patient has been receiving the therapy for at least 28 days prior to screening.
  • Nonsedating antihistamines are permitted.
  • Patient does not need to fast prior screening.
  • Experiencing active psychosis or has a medical history of bipolar, schizophrenia, or schizoaffective disorder.
  • History of severe substance abuse (including benzodiazepines) in the past 12 months. Mild to moderate substance abuse in the past 6 months.
  • a suicide attempt associated with current major depressive episode.
  • Medical history of seizures.
  • History of sleep apnea.
  • Patient has treatment-resistant depression, defined as persistent depressive symptoms despite treatment with adequate doses of antidepressants within the current episode (excluding antipsychotics) from 2 different classes of at least 4 weeks of treatment.
  • Patient has vagus nerve stimulation, electroconvulsive therapy, or has taken ketamine within the current major depressive episode.
  • Psychostimulants (28 days washout) and antipsychotics (14 day washout) are not allowed.
  • Patient has been diagnosed or treated for any type of cancer (excluding basal cell carcinoma and melanoma is situ) within the past year.
  • Patient has had gastric bypass surgery, has  gastric sleeve or lap band, or has had any related procedures that interfere with gastrointestinal transit.
  • Patients expects to perform night shift work during the 14 day treatment period.
  • Patient has tested positive for hepatitis B,C or HIV.

 

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