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NMDA receptor antagonist

Esketamine for Depression

Phase 1
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 14 months
Awards & highlights

Study Summary

The purpose of this study is to explore feasibility of combining clinician-directed cognitive behavioral therapy (CBT) supplemented with the Mindset app with esketamine therapy in participants with Treatment-resistant Depression.

Eligible Conditions
  • Depression

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 14 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 14 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
CBT Therapist Assessment of Completion of Action Plan
Clinician Feedback
Exit Survey
+11 more
Secondary outcome measures
Clinical Global Assessment of Discharge Readiness (CGADR) Score
Clinician Administered Dissociative States Scale (CADSS) Score
Columbia Suicide Severity Rating (C-SSRS) Score
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: EsketamineExperimental Treatment3 Interventions
Participants will receive esketamine nasal spray (Dose 1 or Dose 2) twice weekly for 4 weeks (Induction Phase), followed by once a week dose (Dose 1 or Dose 2) for 8 weeks (Maintenance Phase), in conjunction with an oral antidepressant. Clinician-directed cognitive behavioral therapy (CBT) supplemented with the Mindset app will be administered by a clinician following esketamine dosing once the participants is considered ready to engage in therapy, based on the clinician judgement of CBT readiness.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Behavioral Therapy (CBT)
2008
Completed Phase 4
~3620
Esketamine
2015
Completed Phase 3
~2520
Antidepressant
2017
Completed Phase 3
~158930

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,384,308 Total Patients Enrolled
44 Trials studying Depression
11,783 Patients Enrolled for Depression
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,905 Total Patients Enrolled
36 Trials studying Depression
10,312 Patients Enrolled for Depression

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Ohio
Maryland
How old are they?
18 - 65
What site did they apply to?
Sheppard Pratt Health System
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Assess Feasibility of Using Clinician-directed and Digital Application Supported Cognitive Behavior Therapy (CBT) in Conjunction With Esketamine in Participants With Treatment-resistant Depression
2022. "A Study to Assess Feasibility of Using Clinician-directed and Digital Application Supported Cognitive Behavior Therapy (CBT) in Conjunction With Esketamine in Participants With Treatment-resistant Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05268497.
~0 spots leftby Apr 2025
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