Phase IIb Major Depression Trial
Recruitment Exclusively from Patient Database
Successful Outcome
· No advertisement used
· All study participants were recruited from PCRMG’s patient database
· Site was successful in meeting and exceeding enrollment expectations
Study Description
A 6-week, 3-arm, randomized, double-blind, placebo controlled study to investigate the safety and efficacy of XXXX in male and female patients with Major Depressive Disorder, aged 18 to 65 years. Approximately 324 patients were to be randomly assigned to 1 of 3 treatment arms, including placebo, 2.5 mg XXXX, or 5.0 mg XXXX, in a 2:1:1 ratio.
Criteria Summary
Patients must have undergone treatment with an antidepressant administered at an adequate dose and duration (at least 4 weeks, at the minimum therapeutic dose) in the past for the treatment of Major Depression.
Enrollment Metrics
Enrollment Goal: 9 Patients
Screened: 18 Patients
Randomized: 10 Patients