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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and within 24 hours post treatment 1
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and within 24 hours post treatment 1
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am unable to understand and give consent for treatment.I have been treated with Esketamine or ketamine before.I am at least 18 years old.I am unable to understand and agree to the study's procedures and risks.My hearing or vision problems won't stop me from seeing presentations.A Yale psychiatrist has approved me for esketamine treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention + TAU
- Group 2: Treatment as usual (TAU)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.