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Talking Therapies + Esketamine for Depression (ROSETTE Trial)

N/A
Waitlist Available
Led By Sina Nikayin, MD
Research Sponsored by Yale University
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 baseline and within 24 hours post treatment 1
Awards & highlights
No Placebo-Only Group

Summary

This trial will assess if talking therapies can make esketamine more effective in treating depression.

Who is the study for?
This trial is for adults over 18 who are suitable for esketamine treatment as determined by a Yale Interventional Psychiatry physician. Participants must consent to the study and be able to follow the trial's schedule and requirements.
What is being tested?
The study is testing if non-specific effects, like pretreatment presentations and post-treatment follow-ups, can boost esketamine's effectiveness in treating depression.
What are the potential side effects?
While not specified here, esketamine may cause side effects such as dizziness, nausea, sedation, dissociation (feeling disconnected), increased blood pressure, and euphoria.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and within 24 hours post treatment 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and within 24 hours post treatment 1 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Group difference in change in question 6 score on Treatment Credibility and Expectancy Scale (CEQ-6)
Secondary study objectives
Group difference in change in Montgomery-Åsberg Depression Rating Scale (MADRS) score

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention + TAUExperimental Treatment1 Intervention
Participants receive a presentation prior to the first treatment and receive a "follow up" session within 24 hours after the first treatment in addition to treatment as usual
Group II: Treatment as usual (TAU)Active Control1 Intervention
Participants receive TAU

Find a Location

Who is running the clinical trial?

National Center for Advancing Translational Sciences (NCATS)NIH
378 Previous Clinical Trials
413,036 Total Patients Enrolled
Yale UniversityLead Sponsor
1,930 Previous Clinical Trials
3,033,440 Total Patients Enrolled
1 Trials studying Major Depressive Episode
40 Patients Enrolled for Major Depressive Episode
Sina Nikayin, MDPrincipal InvestigatorYale University
2 Previous Clinical Trials
15 Total Patients Enrolled

Media Library

Intervention + TAU Clinical Trial Eligibility Overview. Trial Name: NCT05910775 — N/A
Major Depressive Episode Research Study Groups: Intervention + TAU, Treatment as usual (TAU)
Major Depressive Episode Clinical Trial 2023: Intervention + TAU Highlights & Side Effects. Trial Name: NCT05910775 — N/A
Intervention + TAU 2023 Treatment Timeline for Medical Study. Trial Name: NCT05910775 — N/A
~15 spots leftby Jul 2025