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

NCT05910775 | Terminated Results

• 2 other identifiers: 20000348292UL1TR001863-06
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Episode

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Group Difference in Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Score

  baseline and within 24 hours post treatment 1

Study Arms (2)

Treatment as usual (TAU)

NO INTERVENTION

Participants receive TAU

Intervention + TAU

EXPERIMENTAL

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

Behavioral: Pre and Post Treatment Presentations

Interventions

Pre and Post Treatment Presentations BEHAVIORAL

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

Intervention + TAU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Center for Advancing Translational Sciences (NCATS): collaborator
• Yale University: lead

Study Sites (1)

Yale Psychiatry Hospital Interventional Psychiatry Services (IPS) unit

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Interventions

Lead

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Metals

Results Point of Contact

• Title: Sina Nikayin, MD
• Organization: Yale University

sina.nikayin@yale.edu

203-688-9719

Study Officials

• Sina Nikayin, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Only outcome assessors collecting MADRS are masked.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients who are deemed clinically appropriate for esketamine will be approached for participation in the study.

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: June 20, 2023
• Study Start: July 13, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 14, 2026
• Results First Posted: January 14, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)