NCT05910775

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-07-13
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2023-06-20
• Last updated: 2026-01-14
• Results posted: 2026-01-14

Locations

1 site across 1 country: United States