Major Depression for Adults
$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.
- 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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