An interventional study of Psychedelic framing and Biomedical framing in Treatment Resistant Depression (TRD), sponsored by Valdemar Landgren. Not yet recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Valdemar Landgren · Not applicable, Interventional, and Treatment
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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.
Ketamine is increasingly used in the treatment of treatment-resistant depression. In this study, ketamine is administered in the same clinical manner in both groups, but the treatment context differs. One group receives a psychedelic framing that presents subjective ketamine experiences as potentially meaningful and therapeutically relevant, while the other group receives a biomedical framing that presents ketamine as a pharmacological treatment and subjective effects as side effects. The study compares the effects of these two framings on depressive symptoms, treatment experience, tolerability, and selected longer-term outcomes measured through follow-up assessments and national registers.
448 studies on the registry are indexed under Depressive Disorder, Treatment-Resistant; 147 are open to participants now.
This study's planned enrollment of 120 is above the median of 59 across 372 interventional studies indexed under Depressive Disorder, Treatment-Resistant.
Browse Depressive Disorder, Treatment-Resistant studies →This is the only study on the registry with Valdemar Landgren as lead sponsor.
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Exclusion Criteria:
- Patients who do not meet the inclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants view a brief video presenting ketamine treatment from a biomedical perspective, emphasizing its pharmacological antidepressant effects. Potential side effects are described, and participants are informed that clinical support will be provided throughout treatment with the aim of alleviating these effects. A healthcare professional is present during all six ketamine infusions. The staff member provides psychological support, helps reduce anxiety, and assists the participant in managing or distracting from side effects such as distressing dissociation. Infusions may be paused if needed. After each infusion, participants are assessed for side effects using the Clinician-Administered Dissociative States Scale (CADSS) and the Brief Psychiatric Rating Scale (BPRS). Participants may choose to use music and/or an eye mask during the infusion if they wish, but these are not actively provided or encouraged by the treatment staff.
Behavioral: Biomedical framing
Participants view a brief video presenting ketamine treatment from a psychedelic perspective, in which the subjective psychoactive effects are described as potentially meaningful and therapeutically relevant. Participants are informed that supportive presence will be provided throughout the session. A healthcare professional is present during all six ketamine infusions. The staff member provides psychological support, encourages participants to engage with their inner experience, and offers reassurance when needed. Infusions may be paused if needed. The treatment setting includes optional supportive elements such as a short mindfulness practice, music and eye mask to facilitate inward focus. After each infusion, participants are invited to reflect on their experience through a semi-structured interview, with clinician time matched to the CADSS and BPRS assessments conducted in the comparator arm.
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
Also known as: Contextual framing, Treatment setting
The intervention includes: * Biomedically framed patient information (video) * Psychological support provided during the infuion towards alleviating side effects such as dissociation * CADSS and BPRS
Also known as: Contextual framing, Treatment setting
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.
Time frame: Baseline to week 12
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.
Time frame: Week 12
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.
Time frame: Baseline, weeks 2, 3, 4, 5, 8, 12, and month 6
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 frame: Baseline, weeks 2, 3, 4, 5, 8, 12, and month 6
Time to hospitalization
Time from baseline to first hospitalization due to depression during follow-up
Time frame: Baseline to 12 months
Adverse events and treatment discontinuation
Incidence of adverse events (mild, moderate, severe) and time to treatment discontinuation for any reason.
Time frame: Baseline to week 12
Ketamine-related adverse effects (Modified KSET)
Ketamine-related adverse effects measured with a modified version of the Ketamine Side Effect Tool (KSET), a 20-item patient-rated scale (0-3 per item; higher scores indicate greater side effect burden).
Time frame: Week 1 and week 4
Quality of life and health (VAS)
Change in self-rated quality of life and health measured with a visual analogue scale from 0 to 100, where higher scores indicate better perceived quality of life and health.
Time frame: Baseline, weeks 2, 3, 4, 5, 8, 12, and months 6 and 12
Satisfaction with life
Life satisfaction measured with the Satisfaction With Life Scale (SWLS). The SWLS has 5 items rated on a 7-point scale, with total scores ranging from 5 to 35. Higher scores indicate greater life satisfaction.
Time frame: Baseline to week 12
Subjective sleep quality
Subjective sleep quality measured with the Brief Pittsburgh Sleep Quality Index (B-PSQI). The questionnaire asks about sleep habits during the previous month and includes bedtime, sleep latency, wake time, sleep duration, nighttime sleep problems, overall sleep quality, and use of sleep medication. Higher scores indicate worse sleep quality.
Time frame: Baseline to week 12
Perceived social support
Perceived social support measured with the Social Provisions Scale-5 (SPS-5). The scale has 5 items rated on a 4-point scale from 1 to 4, with total scores ranging from 5 to 20. Higher scores indicate greater perceived social support.
Time frame: Baseline to week 12
Loneliness
Loneliness measured with the UCLA Loneliness Scale, 3-item version. The scale has 3 items rated from 1 to 3, with total scores ranging from 3 to 9. Higher scores indicate greater loneliness.
Time frame: Baseline to week 12
Screen time
Screen time measured with the Screen Time questionnaire (ScrT), which assesses average daily time spent on social media, gaming, TV/streaming, and background TV/streaming use. Higher response categories indicate more screen exposure.
Time frame: Baseline to week 12
Absorption
Trait absorption measured with the Modified Tellegen Absorption Questionnaire (MODTAS). The questionnaire assesses tendency to become fully absorbed in sensory, imaginative, or experiential activities; higher scores indicate greater absorption.
Time frame: Baseline to week 12
Trait anxiety
Trait anxiety measured with the State-Trait Anxiety Inventory short form (STAI-SF). Higher scores indicate greater anxiety-proneness.
Time frame: Baseline to week 12
Cognitive fusion
Cognitive fusion measured with the Cognitive Fusion Questionnaire (CFQ-7). The questionnaire has 7 items rated on a 7-point scale; total scores range from 7 to 49. Higher scores indicate greater cognitive fusion, meaning more entanglement with thoughts and less psychological flexibility.
Time frame: Baseline to week 12
Goal attainment for behavioral activation
Goal attainment measured with the Goal Attainment Scale for Depression (GAS-D). Individual goals are rated on a 5-point scale from -2 to +2, where 0 reflects expected goal attainment and higher scores indicate better-than-expected attainment.
Time frame: Week 1, 2, 3, 4, 5, 6, 8 and 12
Therapeutic alliance
Therapeutic alliance measured with the Working Alliance Inventory - Short Revised (WAI-SR) completed by participants and the Working Alliance Inventory - Short form (WAI-SRT) completed by clinicians. The instruments assess the quality of the working relationship across goal agreement, task agreement, and bond. Higher scores indicate a stronger therapeutic alliance.
Time frame: baseline, week 2, 6 and 12
Acute mystical and challenging experiences
Acute ketamine-related subjective experiences measured after each infusion with the Mystical Experience Questionnaire short form (MEQ-4) and the Challenging Experience Questionnaire short form (CEQ-7). The MEQ-4 is a 4-item self-report measure of mystical-type experience, scored 0 to 5 per item, with higher scores indicating a stronger mystical experience. The CEQ-7 is a 7-item self-report measure of challenging experience, scored 0 to 5 per item, with higher scores indicating a more difficult or distressing experience.
Time frame: Immediately after each of 6 infusions during weeks 1 to 4
Mystical experience
Mystical experience measured with the Mystical Experience Questionnaire (MEQ-30). The MEQ-30 is a 30-item self-report questionnaire scored on a 0 to 5 scale and assesses mystical-type experience across domains such as unity, sacredness, positive mood, transcendence of time and space, and ineffability. Higher scores indicate a stronger mystical experience.
Time frame: Week 5
Expectancy
Treatment expectation measured with patient- and clinician-rated treatment expectation questionnaires. The patient questionnaire and clinician questionnaire assess expected benefit from treatment and perceived treatment credibility. Higher scores indicate greater treatment expectancy.
Time frame: Baseline, week 1 and 2
Drug liking and perceived drug effects
Acute drug effects measured with the Drug Effect Questionnaire (DEQ). The DEQ uses 0 to 100 visual analogue ratings to assess perceived drug effect, feeling high, liking and disliking effects, and desire for more drug. Higher scores indicate stronger perceived drug effects and greater drug liking or desire for more drug, depending on the item.
Time frame: Immediately after infusion 2 and infusion 6 during weeks 1 and 4
Altered states of consciousness
Altered states of consciousness measured with the 5-Dimensional Altered States of Consciousness Scale (5D-ASC). The 5D-ASC assesses five dimensions of altered consciousness; higher scores indicate a more intense altered state in the relevant dimension.
Time frame: Week 5
Psychological insight
Psychological insight measured with the Psychological Insight Scale (PIS). The PIS contains 7 items rated from 0 to 100 and assesses new insight into one's past, self, lifestyle, and behavior change. Higher scores indicate greater psychological insight.
Time frame: Week 5
Treatment evaluation
Treatment evaluation measured with patient- and clinician-rated treatment evaluation questionnaires. These questionnaires assess overall appraisal of the treatment experience and perceived usefulness of the intervention. Higher scores indicate a more positive treatment evaluation.
Time frame: Week 6
Personality traits
Personality measured with the Ten-Item Personality Inventory (TIPI). The TIPI is a 10-item self-report measure of the Big Five personality traits: extraversion, emotional stability, agreeableness, conscientiousness, and openness to experience. It is administered as a baseline covariate; higher trait scores indicate more of the relevant personality dimension.
Time frame: Baseline
Substance-related convictions or diagnoses
Occurrence of a drug-related conviction or substance use disorder diagnosis during follow-up.
Time frame: 12 months
Work ability and social transfers
Employment-related income and social transfer dependence during follow-up, assessed as income net of social transfers.
Time frame: 12 months
Psychotropic medication use
Average daily defined dose of prescribed psychotropic medication during follow-up.
Time frame: 12 months
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.
Time frame: After infusion 1, infusion 3, and infusion 6 during weeks 1, 2, and 4
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.
Time frame: After each of 6 infusions during weeks 1 to 4
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.
Time frame: After each of 6 infusions during weeks 1 to 4
Incremental costs associated with psychedelic versus biomedical framing
Incremental intervention-related and healthcare costs associated with psychedelic framing compared with biomedical framing.
Time frame: Baseline to 12 months
Plan to share: Yes — De-identified individual participant data will be shared after publication of the main results. Data will include participant-level clinical and outcome data used in the analyses. Supporting documentation such as the study protocol, statistical analysis plan, and analytic code will also be shared.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: Available beginning 12 months after publication of the primary results and remaining available indefinitely, or for the period specified on OSF.
Access criteria: De-identified IPD and supporting documents will be made available via OSF. Access by request.
Data sharing details ↗ · osf.io
Start is estimated for Sep 2026; primary completion for Dec 2029, 39 months later.
Of 136 non-industry interventional studies with no phase under Depressive Disorder, Treatment-Resistant, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 79. This study's planned 39 months is close to that.
Counting every sponsor, half of 140 studies reached it within 50 months; a quarter within 22 and three quarters within 88.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Depressive Disorder, Treatment-Resistant →