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NOT YET RECRUITING
NCT07824973
NA

Ketamine Treatment for Treatment-Resistant Depression - the Role of Framing

Sponsor: Valdemar Landgren

View on ClinicalTrials.gov

Summary

Ketamine is a medicine used in psychiatry for treatment-resistant depression. This study compares two ways of framing ketamine treatment: a psychedelic framing and a biomedical framing. The study will examine whether the framing affects depressive symptoms, treatment experience, tolerability, and longer-term outcomes.

Official title: A Single-center Open-label Randomized Parallel-group Superiority Trial to Compare the Efficacy of Psychedelic and Biomedical Framing of Intravenous Ketamine for Treatment-resistant Depression - the KetSet Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-09

Completion Date

2030-08

Last Updated

2026-09-17

Healthy Volunteers

No

Interventions

BEHAVIORAL

Psychedelic framing

The intervention includes: * Psychedelic framed patient information (video) * Psychedelic environment during infusions (mindfulness practice, music, eye mask) and psychological support provided towards engaging in the inner experience * Interview on the ketamine-induced experience

BEHAVIORAL

Biomedical framing

The intervention includes: * Biomedically framed patient information (video) * Psychological support provided during the infuion towards alleviating side effects such as dissociation * CADSS and BPRS

Locations (1)

Brain Stimulation Clinic, Skaraborg's Hospital

Skövde, Västra Götaland County, Sweden