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

This parallel assignment interventional trial (n=34) is sponsored by Yale University and aims to assess the impact of non-specific effects in the treatment of depressive episodes with esketamine.

Led by Sina Nikayin, MD, the study seeks to determine whether positive presentations before the first treatment improve patients’ expectations of improvement from esketamine treatment within 24 hours after the first session. Secondary objectives include evaluating the effect of post-treatment follow-up sessions on patients’ expectations and assessing the response to treatment as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) score.

The trial will enrol approximately 34 participants, aged 18 or older, who are clinically appropriate to receive esketamine according to Yale Interventional Psychiatry physicians. Eligible participants must provide written consent and be able to comprehend English. Exclusions include hearing or visual impairment, previous esketamine or ketamine treatment, and cognitive disorders impairing understanding.

Participants will be assigned to either the treatment as usual (TAU) group or the intervention group receiving a presentation before the first treatment and a follow-up session. The presentation aims to emphasise treatment effectiveness and provide encouragement, while the follow-up session offers further reassurance. Outcome measures include changes in the Treatment Credibility and Expectancy Scale (CEQ-6) and MADRS scores.

The study is expected to start in April 2024 and conclude by July 2025. Recruitment takes place at the Yale Psychiatry Hospital Interventional Psychiatry Services (IPS) unit in New Haven, Connecticut, United States.

Trial Details

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.

NCT Number NCT05910775

Data attribution

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