A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder
Trial Parameters
Brief Summary
The goal of this clinical trial is to learn if zelquistinel works to treat depression in adults. It will also learn about the safety of zelquistinel. The main questions it aims to answer are: Does zelquistinel reduce depression scores in participants compared to participants who take a placebo (a look-alike tablet that contains no zelquistinel1)? What medical problems are observed in participants who take zelquistinel? Participants will take one tablet of zelquistinel or placebo every week for 6 weeks. Participants will visit the clinic every week of the 6 week period to have the severity of their depression evaluated.
Eligibility Criteria
Inclusion Criteria: * Male or female subject. * Aged 18 to 64 years, inclusive. * Subject has a first episode or recurrent episode diagnosis of MDD, defined by the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), ≥3 weeks and ≤18 months. The diagnosis of MDD will be made by a central rater using the Structured Clinical Interview for DSM-5 Clinical Trials version (SCID-5-CT). * Subject has a HDRS-17 total score of ≥18 at the Screening Visit (V1) and Baseline Visit (V2) as assessed by a central rater, with no more than a 25% change from the Screening Visit (V1) to the Baseline Visit (V2) * Subject has HARS total score ≥15 at the Screening Visit (V1) and predose at the Baseline Visit (V2), AND * Subject has ISI total score ≥10 at the Screening Visit (V1) and predose at the Baseline Visit (V2). * Female subjects must meet 1 of the following: * Surgically sterile or at least 2 years menopausal (ie, postmenopausal is defined as a woman with the absence of menses f