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Clinical Trial Details
A Randomized, Double-blind, Multicenter, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Esketamine Nasal Spray, Administered as Monotherapy, in Adult Participants with Treatment-resistant Depression (ESKTRD4005)
Clinical Trial ( IRB ) #: O21-071-2
Title: A Randomized, Double-blind, Multicenter, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Esketamine Nasal Spray, Administered as Monotherapy, in Adult Participants with Treatment-resistant Depression (ESKTRD4005)
Principal Investigator: Dr. Jayesh Kamath
Description: This is a clinical research study of an investigational medication for adults with treatment-resistant depression (TRD). The purpose of this study is to evaluate the effectiveness, safety, and tolerability of the investigational medication when it is used alone in adults with TRD. Study participation will last up to 24 weeks and includes a screening phase, a double-blind phase, an open-label/observation phase, and a follow-up phase. Qualified participants may receive investigational study medication and some study-required medical care at no cost.
Classification:
  Psychiatry - General Adult/Mental Health (Depression, Anxiety, Etc.)
Eligibility Criteria: Adults 18 years of age or older; have been diagnosed with treatment-resistant depression; have not adequately responded to at least 2 different antidepressant treatments; for additional eligibility criteria, check with study contact
How to Contact: Galina Prpich. Telephone: 860-679-7539 Email: prpich@uchc.edu
Enrollment Status/Comments: Enrolling/recruiting