Esketamine- 4005: Research Study for Treatment Resistant Depression

Study Information

The purpose of this study is to understand whether esketamine effectively treats treatment-resistant depression (TRD) as a monotherapy. Esketamine is currently FDA approved to treat TRD when it is administered with an oral antidepressant. This study aims to determine whether esketamine is effective when taken without an oral antidepressant.

Participation involves a Screening Phase, during which eligibility will be assessed through various study procedures including assessments and physical exams/labs If a subject passes the screening requirements, they will be instructed to taper off medications used for depression. All subjects must be antidepressant free for 2 weeks prior to dosing. The Screening Phase is followed by a 4 week Double Blind Phase, during which subjects will receive either active esketamine or a placebo twice weekly.

After the Double Blind Phase, subjects can opt to participate in the Open-Label Phase for up to 12 weeks. Subjects may choose to receive esketamine treatment during this phase, regardless of whether they received a placebo or esketamine in the Double Blind Phase.

Subjects will be compensated for in-person visits, and transportation for all dosing visits is covered. Subjects must be available during working hours (9-5 M-F).

Eligibility Requirements

This study is for adults (18 and older) with treatment resistant depression (i.e., non-response to at least 2 oral antidepressant treatments in the current episode of depression). For more information regarding eligibility, contact the Neuromodulation Research Program at 401-680-4143 or submit your information via out contact form above.

Fill out the form below or call (401) 680-4143 to contact our research team.

 

Organization
Butler Hospital

Area of Study
Mood Disorders

Recruitment Status
Open