Talking Therapies + Esketamine for Depression

(ROSETTE Trial)

Overseen By Sina Nikayin, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Must be taking: Esketamine

Disqualifiers: Dementia, Cognitive disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 30 days

Trial Summary

What is the purpose of this trial?

The investigators aim to examine the magnitude of non-specific effects in the treatment of depressive episodes with esketamine, by providing patients in the intervention group with a pretreatment presentation and post-treatment follow up session, to assess whether nonspecific effects can be used effectively to improve the effectiveness of treatment with esketamine.

Research Team

Sina Nikayin, MD

Principal Investigator

Yale University

Eligibility Criteria

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.

Inclusion Criteria

A Yale psychiatrist has approved me for esketamine treatment.

Written consent for the study procedures

Ability and willingness, in the investigator's judgement, to comply with the study schedule, treatment plan, and other trial requirements for the duration of the study.

Exclusion Criteria

I am unable to understand and give consent for treatment.

Any other medical or psychiatric comorbidity that the investigator judges would put the participant at additional undue risk due to study participation or would impair subject's ability to participate in the study

I have been treated with Esketamine or ketamine before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive esketamine treatment for depressive episodes, including a positive presentation before the first treatment and a follow-up session within 24 hours after the first treatment

Up to 30 days

Multiple visits including pre-treatment presentation and post-treatment follow-up

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a focus on changes in MADRS and CEQ-6 scores

4 weeks

Treatment Details

Interventions

• Pre and Post Treatment Presentations

Trial Overview The study is testing if non-specific effects, like pretreatment presentations and post-treatment follow-ups, can boost esketamine's effectiveness in treating depression.

Participant Groups

Group I: Intervention + TAU Experimental Treatment 1 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 Control 1 Intervention

Participants receive TAU

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+