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

Yale University

Status: Terminated

Conditions: Depressive Episode

Treatments: Behavioral: Pre and Post Treatment Presentations

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05910775

2000034829

2UL1TR001863-06 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

Primary Objective:

To determine whether a positive presentation before first treatment improves expectation of improvement from treatment in patients receiving esketamine for a depressive episode within 24 hours after the first treatment.

Secondary Objectives:

To determine whether a post-treatment follow up session to provide encouragement and reassurance improves expectation of improvement from treatment in patients receiving esketamine for a depressive episode within 24 hours after the first treatment.

To determine whether a positive presentation results in an improved response from treatment in patients receiving esketamine for a depressive episode as measured by MADRS score within 24 hours after the first treatment.

To determine whether a positive presentation before first treatment, combined with a posttreatment follow up session after first treatment, result in an improved response from treatment in patients receiving esketamine for a depressive episode as measured by MADRS score by the end of the acute course of esketamine treatment.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants must be either male or female and at least 18 years old
• Deemed clinically appropriate to receive esketamine by a Yale Interventional Psychiatry physician.
• 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

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Parallel Assignment

Masking: Single Blind

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1 participants in 2 patient groups

Treatment as usual (TAU)

No Intervention group

Description:

Participants receive TAU

Intervention + TAU

Experimental group

Description:

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

Treatment:

Behavioral: Pre and Post Treatment Presentations