Clinical trial NCT05910775: Role Of Non-Specific Effects in The Treatment of Depression With Esketamine
Official title: Role Of Non-Specific Effects in The Treatment of Depression With Esketamine
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Depressive Episode
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2023-06-20
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Intervention model description: Patients who are deemed clinically appropriate for esketamine will be approached for participation in the study.
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Group difference in change in question 6 score on Treatment Credibility and Expectancy Scale (CEQ-6)
timeFrame: baseline and after presentation (before treatment 1), up to 30 days
Secondary outcomes:
measure: Group difference in change in Montgomery-Åsberg Depression Rating Scale (MADRS) score
timeFrame: baseline and within 24 hours post treatment 1
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Psychiatry Hospital Interventional Psychiatry Services (IPS) unit
state: Connecticut
Study officials:
affiliation: Yale University
name: Sina Nikayin, MD
role: PRINCIPAL_INVESTIGATOR
References: