Clinical TrialDepressive DisordersTerminated

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

This parallel assignment interventional trial (n=34 planned; 1 enrolled per registry) assesses whether pre‑treatment presentation and a post‑treatment follow-up improve expectation and response to esketamine for depressive episodes.

Target Enrollment
1 participants
Study Type
Phase NA interventional
Design
Non-randomized, single Blind

Detailed Description

The study tests whether a positive presentation before the first esketamine treatment improves patients' expectation of improvement within 24 hours after the first treatment.

A second aim is to determine whether a post‑treatment follow‑up session providing encouragement and reassurance improves expectation and clinical response (MADRS) within 24 hours and by the end of the acute esketamine course.

Parallel design comparing TAU versus pre‑/post‑treatment presentations plus TAU; outcome assessors collecting MADRS are masked (single‑blind).

Study Protocol

Preparation

1 sessions

Dosing

sessions

Integration

1 sessions

Study Arms & Interventions

TAU

active comparator

Participants receive treatment as usual (TAU)

Intervention + TAU

experimental

Presentation prior to first esketamine treatment plus a follow-up session within 24 hours, in addition to TAU

Interventions

  • Compound
    via Other• single presentation + single follow-up

    Short presentation within 72 hours prior to first treatment emphasising effectiveness and encouragement; one follow-up session within 24 hours post-first treatment to provide encouragement and reassurance (delivered alongside TAU).

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:\n\n* Participants must be either male or female and at least 18 years old\n* Deemed clinically appropriate to receive esketamine by a Yale Interventional Psychiatry physician.\n* Written consent for the study procedures\n* 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

  • Exclusion Criteria:\n\n* Hearing or visual impairment to the degree that would interfere with ability to view the presentation\n* Difficulty in understanding spoken or written English\n* Unable to provide informed consent\n* Dementia or other cognitive disorder or intellectual disability that would impair the subject's ability to understand the presentation (per investigator judgment)\n* 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.\n* Previous Esketamine or ketamine treatment\n* Unable to give informed consent\n* Was previously enrolled/randomized into the trial

Study Details

  • Status
    Terminated
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Non-randomizedsingle Blind
  • Target Enrollment1 participants
  • Timeline
    Start: 2024-04-01
    End: 2025-07-31
  • Topic
    Depressive Disorders

Locations

Yale Psychiatry Hospital Interventional Psychiatry Services (IPS) unit — New Haven, Connecticut, United States

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