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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in depressive symptoms (MADRS total score)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prescribed ketamine treatment for depression
- •Able to understand study information and provide informed consent
排除标准
- •- Patients who do not meet the inclusion criteria
研究组 & 干预措施
Biomedical framing of ketamine treatment
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.
干预措施: Biomedical framing (Behavioral)
Psychedelic framing of ketamine treatment
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.
干预措施: Psychedelic framing (Behavioral)
结局指标
主要结局
Change in depressive symptoms (MADRS total score)
时间窗: 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.
次要结局
- MADRS response and remission(Week 12)
- Self-reported depressive symptoms (MADRS-S)(Baseline, weeks 2, 3, 4, 5, 8, 12, and month 6)
- Suicidal ideation (MADRS-S item 9)(Baseline, weeks 2, 3, 4, 5, 8, 12, and month 6)
- Time to hospitalization(Baseline to 12 months)
- Adverse events and treatment discontinuation(Baseline to week 12)
- Ketamine-related adverse effects (Modified KSET)(Week 1 and week 4)
- Quality of life and health (VAS)(Baseline, weeks 2, 3, 4, 5, 8, 12, and months 6 and 12)
- Satisfaction with life(Baseline to week 12)
- Subjective sleep quality(Baseline to week 12)
- Perceived social support(Baseline to week 12)
- Loneliness(Baseline to week 12)
- Screen time(Baseline to week 12)
- Absorption(Baseline to week 12)
- Trait anxiety(Baseline to week 12)
- Cognitive fusion(Baseline to week 12)
- Goal attainment for behavioral activation(Week 1, 2, 3, 4, 5, 6, 8 and 12)
- Therapeutic alliance(baseline, week 2, 6 and 12)
- Acute mystical and challenging experiences(Immediately after each of 6 infusions during weeks 1 to 4)
- Treatment evaluation(Week 6)
- Mystical experience(Week 5)
- Expectancy(Baseline, week 1 and 2)
- Drug liking and perceived drug effects(Immediately after infusion 2 and infusion 6 during weeks 1 and 4)
- Altered states of consciousness(Week 5)
- Psychological insight(Week 5)
- Personality traits(Baseline)
- Substance-related convictions or diagnoses(12 months)
- Work ability and social transfers(12 months)
- Psychotropic medication use(12 months)
研究者
Valdemar Landgren
PhD, psychiatrist
Vastra Gotaland Region