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

Depressive Episode Clinical Trial

— ROSETTE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05910775
• Other study ID #: 2000034829
• Secondary ID: 2UL1TR001863-06
• Status: Recruiting
• Phase: N/A
• Start date: May 3, 2024
• Est. completion date: July 2025

Study information

• Verified date: May 2024
• Source: Yale University
• Contact: Sina Nikayin, MD
• Phone: 203-688-9719
• Email: sina.nikayin[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Episode

Intervention

Behavioral:
• Pre and Post Treatment Presentations
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

Locations

Country	Name	City	State
United States	Yale Psychiatry Hospital Interventional Psychiatry Services (IPS) unit	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline and after presentation (before treatment 1), up to 30 days
Secondary	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.	baseline and within 24 hours post treatment 1