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

Primary Purpose

Depressive Episode

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pre and Post Treatment Presentations
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Depressive Episode

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Yale Psychiatry Hospital Interventional Psychiatry Services (IPS) unit

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Treatment as usual (TAU)

Intervention + TAU

Arm Description

Participants receive TAU

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

Outcomes

Primary Outcome Measures

Group difference in change in question 6 score on Treatment Credibility and Expectancy Scale (CEQ-6)
Participants' expectations will be assessed by the change in the group score of item 6 of the CEQ-6 at baseline and after the presentation (before treatment 1). Item 6 is scored from 0% (not at all) to 100% (very much). Higher scores indicates expectations have been met.

Secondary Outcome Measures

Group difference in change in Montgomery-Åsberg Depression Rating Scale (MADRS) score
MADRS score will be used to assess whether a positive presentation results in an improved response from treatment in participants receiving esketamine for a depressive episode within 24 hours after the first treatment. MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes. Each item is rated on a 0-6 scale, resulting in a maximum total score of 60 points, with higher scores indicative of greater depressive symptomology.

Full Information

First Posted
June 6, 2023
Last Updated
October 12, 2023
Sponsor
Yale University
Collaborators
National Center for Advancing Translational Sciences (NCATS)
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1. Study Identification

Unique Protocol Identification Number
NCT05910775
Brief Title
Role Of Non-Specific Effects in The Treatment of Depression With Esketamine
Acronym
ROSETTE
Official Title
Role Of Non-Specific Effects in The Treatment of Depression With Esketamine
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Center for Advancing Translational Sciences (NCATS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Episode

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients who are deemed clinically appropriate for esketamine will be approached for participation in the study.
Masking
Outcomes Assessor
Masking Description
Only outcome assessors collecting MADRS are masked.
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment as usual (TAU)
Arm Type
No Intervention
Arm Description
Participants receive TAU
Arm Title
Intervention + TAU
Arm Type
Experimental
Arm 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
Intervention Type
Behavioral
Intervention Name(s)
Pre and Post Treatment Presentations
Intervention Description
A short presentation provided to the participants within 72 hours prior to the first treatment of the acute course. The presentation will emphasize the effectiveness of the treatment, and provide notable encouragement and reassurance. The intervention group will additionally receive a follow up session within 24 hours after the first treatment to provide encouragement and reassurance
Primary Outcome Measure Information:
Title
Group difference in change in question 6 score on Treatment Credibility and Expectancy Scale (CEQ-6)
Description
Participants' expectations will be assessed by the change in the group score of item 6 of the CEQ-6 at baseline and after the presentation (before treatment 1). Item 6 is scored from 0% (not at all) to 100% (very much). Higher scores indicates expectations have been met.
Time Frame
baseline and after presentation (before treatment 1), up to 30 days
Secondary Outcome Measure Information:
Title
Group difference in change in Montgomery-Åsberg Depression Rating Scale (MADRS) score
Description
MADRS score will be used to assess whether a positive presentation results in an improved response from treatment in participants receiving esketamine for a depressive episode within 24 hours after the first treatment. MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes. Each item is rated on a 0-6 scale, resulting in a maximum total score of 60 points, with higher scores indicative of greater depressive symptomology.
Time Frame
baseline and within 24 hours post treatment 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sina Nikayin, MD
Phone
203-688-9719
Email
sina.nikayin@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sina Nikayin, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale Psychiatry Hospital Interventional Psychiatry Services (IPS) unit
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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