Major Depressive Disorder Research Studies
Depression Study Details - Click Here
Researchers will look at the long-term effectiveness and safety of an investigational medication (given as a nasal spray) in patients who have not responded to prior treatment with at least two antidepressants. This is a randomized, double-blind, active-controlled, multicenter study in male and female adult subjects with TRD to assess the efficacy, safety, and tolerability of fixed dosed intranasal esketamine (56 mg or 84 mg) plus a newly initiated oral antidepressant compared with a newly initiated oral antidepressant (active comparator) plus intranasal placebo. Approximately 348 subjects will be randomly assigned at a 1:1:1 ratio to receive double-blind intranasaltreatment with either esketamine 56 mg, esketamine 84 mg, or placebo. The intranasal treatment sessions (esketamine or placebo) will occur twice weekly. In addition, all subjects will initiate a new open-label oral antidepressant on Day 1 that will be taken daily for the duration of this phase. At the end of the induction phase, subjects who are responders (defined as ³50% reduction in the MADRS total score from baseline [Day 1 pre-randomization] to the end of the 4 week double-blind induction phase) may be eligible to participate in the subsequent study ESKETINTRD3003 if they meet all other study entry criteria (ESKETINTRD3003 is a longer-term efficacy maintenance study involving repeated treatment sessions of intranasal esketamine).
To be considered for the study, you must be:
- 18 years of age or older
- Diagnosed with depression
- Experiencing depression symptoms despite having taken at least two antidepressant medications in the past 2 years.
- Comfortable with using a nasal spray
- Able to provide written informed consent
The study doctor will discuss additional requirements for being in the study.
If you are eligible for this study and choose to participate, you will receive all study visits and study-related medical care at no cost to you. Compensation for your time and travel expenses may also be provided.
Interested in participating in this study?
Completing this form in no way obligates you to participate in a clinical trial, but may result in a research member contacting you by phone or email to assess your qualification into one of our research studies.