Treatment Resistant Depression (TRD)KetSetNCT07824973
Ketamine Treatment for Treatment-Resistant Depression - the Role of Framing
A study testing Psychedelic framing and Biomedical framing in people with Treatment Resistant Depression (TRD), run by Valdemar Landgren at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treatment Resistant Depression (TRD)
- What is being tested?
- Psychedelic framing and Biomedical framing
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2026to Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prescribed ketamine treatment for depression
- Able to understand study information and provide informed consent
Who cannot join
- Patients who do not meet the inclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
Brain Stimulation Clinic, Skaraborg's Hospital
Skövde, Västra Götaland County, 54160
Alexandra Leinonen, MD, +46706371348, alexandra.leinonen@gu.se
About this study
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
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.
Read the detailed description
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.
- Conditions
- Treatment Resistant Depression (TRD)
- Being tested
- Psychedelic framing, Biomedical framing
- Keywords
- ketamine, psychological framing, psychedelic
- Medical subject headings
- Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychedelic framingBehavioural
Also called Contextual framing, Treatment setting
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
Biomedical framingBehavioural
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| Biomedical framing of ketamine treatment | Active comparator | 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. Receives: Behavioral: Biomedical framing |
| Psychedelic framing of ketamine treatment | Experimental | 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. Receives: Behavioral: Psychedelic framing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to week 12
Secondary outcomes (28)
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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: Baseline to 12 months
Adverse events and treatment discontinuation
Incidence of adverse events (mild, moderate, severe) and time to treatment discontinuation for any reason.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Substance-related convictions or diagnoses
Occurrence of a drug-related conviction or substance use disorder diagnosis during follow-up.
Measured: 12 months
Work ability and social transfers
Employment-related income and social transfer dependence during follow-up, assessed as income net of social transfers.
Measured: 12 months
Psychotropic medication use
Average daily defined dose of prescribed psychotropic medication during follow-up.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Resistant Depression (TRD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized 1:1 to receive ketamine treatment with either psychedelic framing or biomedical framing. The ketamine dosing and infusion schedule are identical in both groups; only the framing and supporting context differ.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Valdemar Landgren
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Valdemar Landgren, Vastra Gotaland Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07824973
- Sponsor's protocol ID
- 2025-07756-01
- Other IDs
- 2025
- Acronym
- KetSet
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07824973
- Acronym / sponsor ID
- KetSet / 2025-07756-01
- Conditions
- Treatment Resistant Depression (TRD)
- Keywords
- ketamine, psychological framing, psychedelic
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Valdemar LandgrenOther government
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomized 1:1 to receive ketamine treatment with either psychedelic framing or biomedical framing. The ketamine dosing and infusion schedule are identical in both groups; only the framing and supporting context differ.
| Arm | Type | Receives |
|---|---|---|
| Biomedical framing of ketamine treatment | Active comparator | Behavioral: Biomedical framingParticipants 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. |
| Psychedelic framing of ketamine treatment | Experimental | Behavioral: Psychedelic framingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Prescribed ketamine treatment for depression
- Able to understand study information and provide informed consent
Key exclusion criteria (1 listed)
- Patients who do not meet the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychedelic framingAlso: Contextual framing, Treatment settingThe 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 | Behavioural | Psychedelic framing of ketamine treatment |
| Biomedical framingAlso: Contextual framing, Treatment settingThe intervention includes: * Biomedically framed patient information (video) * Psychological support provided during the infuion towards alleviating side effects such as dissociation * CADSS and BPRS | Behavioural | Biomedical framing of ketamine treatment |
Primary outcome
Change in depressive symptoms (MADRS total score)
Time frame: Baseline to week 12
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.
28 secondary outcomes
MADRS response and remission
Time frame: Week 12
Self-reported depressive symptoms (MADRS-S)
Time frame: Baseline, weeks 2, 3, 4, 5, 8, 12, and month 6
Suicidal ideation (MADRS-S item 9)
Time frame: Baseline, weeks 2, 3, 4, 5, 8, 12, and month 6
Time to hospitalization
Time frame: Baseline to 12 months
Adverse events and treatment discontinuation
Time frame: Baseline to week 12
Ketamine-related adverse effects (Modified KSET)
Time frame: Week 1 and week 4
Quality of life and health (VAS)
Time frame: Baseline, weeks 2, 3, 4, 5, 8, 12, and months 6 and 12
Satisfaction with life
Time frame: Baseline to week 12
Subjective sleep quality
Time frame: Baseline to week 12
Perceived social support
Time frame: Baseline to week 12
Loneliness
Time frame: Baseline to week 12
Screen time
Time frame: Baseline to week 12
Absorption
Time frame: Baseline to week 12
Trait anxiety
Time frame: Baseline to week 12
Cognitive fusion
Time frame: Baseline to week 12
Goal attainment for behavioral activation
Time frame: Week 1, 2, 3, 4, 5, 6, 8 and 12
Therapeutic alliance
Time frame: baseline, week 2, 6 and 12
Acute mystical and challenging experiences
Time frame: Immediately after each of 6 infusions during weeks 1 to 4
Mystical experience
Time frame: Week 5
Expectancy
Time frame: Baseline, week 1 and 2
Drug liking and perceived drug effects
Time frame: Immediately after infusion 2 and infusion 6 during weeks 1 and 4
Altered states of consciousness
Time frame: Week 5
Psychological insight
Time frame: Week 5
Treatment evaluation
Time frame: Week 6
Personality traits
Time frame: Baseline
Substance-related convictions or diagnoses
Time frame: 12 months
Work ability and social transfers
Time frame: 12 months
Psychotropic medication use
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychedelic framing and Biomedical framing in people with Treatment Resistant Depression (TRD), run by Valdemar Landgren at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandra Leinonen, MD (+46706371348, alexandra.leinonen@gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depressive symptoms (MADRS total score) (time frame: Baseline to week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.