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.
Prescribed ketamine treatment for depression
Able to understand study information and provide informed consent
None
Parallel
Psychedelic framing
BehavioralThe 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
Biomedical framing
BehavioralThe intervention includes: * Biomedically framed patient information (video) * Psychological support provided during the infuion towards alleviating side effects such as dissociation * CADSS and BPRS
Change in depressive symptoms (MADRS total score)
Mean change from baseline to week 12 in depressive symptoms measured with the Montgomery-Åsberg Depression Rating Scale (MADRS). The MADRS is a clinician-rated 10-item scale (0-6 per item; total score range 0-60), with higher scores indicating more severe depression.
MADRS response and remission
Proportion of participants achieving response and remission at week 12 based on MADRS total score. Response is defined as ≥50% reduction from baseline. Remission is defined as MADRS \<11.
Self-reported depressive symptoms (MADRS-S)
Change over time in self-reported depressive symptoms measured with the Montgomery-Åsberg Depression Rating Scale - Self-rated (MADRS-S). The MADRS-S is a 9-item scale (0-6 per item; total score range 0-54), with higher scores indicating more severe depression.
Suicidal ideation (MADRS-S item 9)
Change over time in self-reported suicidal ideation measured by item 9 of the MADRS-S (score 0-6; higher scores indicate greater severity).
Time to hospitalization
Time from baseline to first hospitalization due to depression during follow-up
Subjective ketamine experience interview
Subjective ketamine experience assessed with a semi-structured post-infusion interview in the psychedelic treatment group only. The interview explores sensory experiences, emotions, thought control, self-body experience, space, time, mystical or spiritual experiences, changes in meaning, and post-session insight. Interview reports will be transcribed and content-analyzed to derive quantitative and thematic results.
Acute dissociative symptoms
Dissociative symptoms measured with the Clinician Administered Dissociative States Scale (CADSS) in the biomedical treatment group only. The CADSS is a clinician-administered scale with 23 items rated 0 to 4, assessing experiences such as depersonalization, derealization, altered body perception, altered sense of time, and memory gaps. Higher scores indicate greater dissociation.
Acute psychiatric symptoms
Acute psychiatric symptoms measured with the Brief Psychiatric Rating Scale (BPRS) in the biomedical treatment group only. The BPRS is a clinician-rated interview scale assessing symptoms such as anxiety, depression, hostility, unusual thought content, hallucinations, and disorganization. Higher scores indicate greater psychiatric symptom severity.
Incremental costs associated with psychedelic versus biomedical framing
Incremental intervention-related and healthcare costs associated with psychedelic framing compared with biomedical framing.
Click on the lead sponsor to view all of their trials.
Valdemar Landgren
Lead sponsor
Vastra Gotaland Region
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
