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

NCT ID: NCT05910775

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-13
• Study Completion Date: 2024-12-31

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.

Conditions

Depressive Episode

Study Design

• Allocation Method: NA
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Treatment as usual (TAU)

Participants receive TAU

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention + 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

Group Type: EXPERIMENTAL

Pre and Post Treatment Presentations

Intervention Type: 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

Interventions

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sina Nikayin, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale Psychiatry Hospital Interventional Psychiatry Services (IPS) unit

New Haven, Connecticut, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2UL1TR001863-06

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000034829

Identifier Type: -

Identifier Source: org_study_id