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Talking Therapies + Esketamine for Depression (ROSETTE Trial)

N/A

Recruiting

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

ROSETTE Trial 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.Check my eligibility

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.See study design

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.

ROSETTE Trial 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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Group difference in change in question 6 score on Treatment Credibility and Expectancy Scale (CEQ-6)

Secondary outcome measures

Group difference in change in Montgomery-Åsberg Depression Rating Scale (MADRS) score

ROSETTE 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Center for Advancing Translational Sciences (NCATS)NIH

322 Previous Clinical Trials

401,485 Total Patients Enrolled

Yale UniversityLead Sponsor

1,853 Previous Clinical Trials

2,738,527 Total Patients Enrolled

1 Trials studying Major Depressive Episode

40 Patients Enrolled for Major Depressive Episode

Sina Nikayin, MDPrincipal InvestigatorYale University

1 Previous Clinical Trials

10 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

Frequently Asked Questions

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

Is this experiment currently searching for participants?

"This treatment is not presently looking for patients, as the last update to clinicaltrials.gov was made on June 6th 2023. Yet, there are 1,204 other trials actively recruiting individuals at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Role Of Non-Specific Effects in The Treatment of Depression With Esketamine

2024. "Role Of Non-Specific Effects in The Treatment of Depression With Esketamine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05910775.

All > Depression New York