2024-512911-34-00招募中2 期
Efficacy of psilocybin and trazodone combination in treatment-resistant depression: a randomized controlled proof-of-concept study (PSILOTRAZ)
Groupe Hospitalier Universitaire Paris Psychiatrie & Neuroscience1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2025年6月13日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- The efficacy of the single administration of the psilocybin + trazodone 30 mg combination at 1 month will be assessed by the mean difference of Montgomery-Åsberg Depression Rating Scale (MADRS) scores between M1 (V6) and Baseline (V2), between the following groups: psilocybin + trazodone 30 mg (Group 3) and placebo + trazodone (Group 4).
研究概览
简要总结
To evaluate the efficacy of a single administration of the combination of psilocybin 25 mg + trazodone 30 mg (compared to placebo), administered with psychotherapeutic support in adult patients with TRD, in improving symptoms of depression at 1 month.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old
- •Patient with major depressive episode without psychotic features according to DSM-5 criteria
- •MADRS score ≥ 20
- •Treatment-resistant depressive episode, i.e. failure to respond to at least two lines of antidepressant medication at an adequate dose and for a sufficient period of time (6 weeks according to the MGH-ATRQ)
- •Free, informed and prior written consent of the patient
- •Persons covered by the social security system
排除标准
- •Bipolar disorder
- •Uncontrolled thyroid disorder
- •Significant suicide risk, as defined by: (a) suicidal ideation as indicated by items 4 or 5 on the C-SSRS within the past six months, at Screening, during the Screening Period, or at Baseline (b) demonstrating suicidal behaviors in the past six months, or; (c) clinical assessment of significant suicidal risk or risk of self-injury during participant interview
- •Contraindications to MRI: Implants (mechanical or electronic: cochlear implants, pacemakers, infusion pumps, magnetic clips, etc.) incompatible with the magnetic field; Metallic foreign bodies in the eye or nervous system; Claustrophobia; Non-removable dental removable braces
- •5-HT2A antagonist treatment (including quetiapine, olanzapine, aripiprazole)
- •Lithium treatment
- •Treatment with buprenorphine or opioids
- •Use of psychedelics (psilocybin, lysergic acid, ayahuasca, mescaline and derivatives) during current episode
- •Persons deprived of their liberty by judicial or administrative decision, persons under compulsory psychiatric care
- •Persons under legal protection or unable to give consent
- •Any clinical event that, in the opinion of the investigator, may interfere with the interpretation of study results or constitute a health risk to the participant if he or she participates in the study
- •Schizophrenia and psychosis
- •Patient with a psychiatric decompensation following a previous use of psychedelic substance like LSD
- •Parkinson’s disease treated by selegiline or levodopa
- •HIV treated by ritonavir and indinavir
- •Active infection treated by erythromycin
- •Fungal infection treated by ketoconazole and itraconazole
- •Concomitant therapies
- •Legal status
- •Other: Any clinical manifestation which, in the opinion of the investigator, may interfere with the interpretation of study results or constitute a health risk to the participant if he or she participates in the study
- •Personal or family history of psychotic disorder
- •History of personality disorder
- •Post-traumatic stress disorder, obsessive-compulsive disorder, eating disorders
- •Alcohol or substance use disorder in past 12 months or positive urine toxins at time of assessment
- •Pregnancy and breastfeeding women
- •Cardiovascular history (myocardial infarction, stroke, heart rhythm disorder, uncontrolled hypertension, QT interval prolongation, tachycardia and poor cardiovascular health)
- •Uncontrolled diabetes
结局指标
主要结局
The efficacy of the single administration of the psilocybin + trazodone 30 mg combination at 1 month will be assessed by the mean difference of Montgomery-Åsberg Depression Rating Scale (MADRS) scores between M1 (V6) and Baseline (V2), between the following groups: psilocybin + trazodone 30 mg (Group 3) and placebo + trazodone (Group 4).
The efficacy of the single administration of the psilocybin + trazodone 30 mg combination at 1 month will be assessed by the mean difference of Montgomery-Åsberg Depression Rating Scale (MADRS) scores between M1 (V6) and Baseline (V2), between the following groups: psilocybin + trazodone 30 mg (Group 3) and placebo + trazodone (Group 4).
次要结局
- MADRS scores at Baseline (V2) and M1 (V6) in the groups not tested in the primary endpoint (Group 1, 2 and 4)
- MADRS scores at Inclusion (V1), Baseline (V2), H7 (V3), D1 (V4), D7 (V5), M2 (V7) and M3 (V8) in each group (Group 1, 2, 3 and 4)
- Beck Depression Inventory (BDI) questionnaire scores at Inclusion (V1), Baseline (V2), H7 (V3), D1 (V4), D7 (V5), M1 (V6), M2 (V7) and M3 (V8) in each group
- C-SSRS scores at Inclusion (V1), Baseline (V2), H7 (V3), D1 (V4), D7 (V5), M1 (V6), M2 (V7) and M3 (V8) in each group
- The response rate, defined as the proportion of patients with 50% reduction in MADRS score in each group at D7 (V5), M1 (V6), M2 (V7) and M3 (V8)
- The remission rate defined as the proportion of patients with remission (i.e. MADRS score <10) in each group at D7 (V5), M1 (V6), M2 (V7) and M3 (V8)
- Side effects in all groups between study drug administration at D0 (V3), D1 (V4), D7 (V5), M1 (V6), M2 (V7) and M3 (V8) including vital signs worsening and biological adverse events (AE) (laboratory exams worsening)
- YMRS scores at Inclusion (V1), Baseline (V2), H7 (V3), D1 (V4), D7 (V5), M1 (V6), M2 (V7) and M3 (V8) in each group
- Proportion of patients with an introduction of a new antidepressant after study treatment administration (D0) in each group
- Correlation degree between maximal 5D-ASC and Mystical Experience Questionnaire (MEQ30) scores recorded during study drug administration (D0) and therapeutic efficacy assessed by MADRS score at M1 (V6)
- Stanford Expectations of Treatment Scale (SETS) score and the Credibility/Expectancy Questionnaire (CEQ) score at Baseline (V2) according to MADRS score at D7 (V5), M1 (V6), M2 (V7) and M3 (V8)
- Quality of Life in Depression Scale (QLDS) score at Inclusion (V1), Baseline (V2), D7 (V5), M1 (V6), M2 (V7) and M3 (V8)
- Cognitive task performance measured before (Baseline (V2)), during (D0 (V3)) and after study treatment administration (D7 (V5), M1 (V6) and M3 (V8)) by accuracy, reaction time and EEG signals
- Brain activity measured by resting EEG before (Baseline (V2)), during (D0 (V3)) and after study treatment administration (D7 (V5), M1 (V6) and M3 (V8))
- Immune and neuroplasticity biomarkers dosage before (Baseline (V2)) and after study treatment administration (D1 (V4), D7 (V5), M1 (V6) and M3 (V8))
- Independent factors and clinical response obtained during the study, defined as a 50% reduction in MADRS score
- Brain structure and activity measured by Magnetic Resonance Imaging (MRI) and EEG in the Group 4 during the open-label extension phase (if applicable). MRI + EEG will be recorded at rest and during the performance of cognitive tasks, before psilocybin administration (V2) and after administration (D7 ± 1 day (V5) and M1 ± 3 days (V6))
- MADRS scores at Baseline (V2) and M1 (V6) in the Group 4 and 4C (receiving psilocybin 25 mg in the open-label extension phase) as within-subject measures of psilocybin efficacy
- MADRS scores at Baseline (V2) and M1 (V6) in the Group 1 and 4C (receiving psilocybin 25 mg in the open-label extension phase) as within-subject measures of efficacy and in the Group 1 and 4C to assess the influence of blindness
研究者
Sylla
Scientific
Groupe Hospitalier Universitaire Paris Psychiatrie & Neuroscience
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Psilocybin in alcohol use disorder with comorbid depression - Randomized double-blind controlled pilot study.alcohol use disorder2023-506647-42-00Centre Hospitalier Universitaire De Nimes, Centre Hospitalier Universitaire De Nimes30
招募中
1 期
RCT of Psilocybin-assisted CBT for DepressionMajor Depressive DiorderNCT07281352University of California, Los Angeles50
招募中
1 期
Psilocybin's effects on anhedoniaMajor Depressive Disorder2024-519265-22-00Medical University Of Vienna65
进行中（未招募）
1 期
Safety and Preliminary Efficacy of Organic Whole Psilocybin-Containing Mushrooms to Treat Patients Suffering From PTSDPTSDNCT07275970Scottsdale Research Institute24
招募中
2 期
Efficacy of Psilocybin and Trazodone Combination in Treatment-resistant Depression: a Randomized Controlled Proof-of-concept Study (PSILOTRAZ)Depression - Major Depressive DisorderTreatment-resistant Depression (TRD)NCT07210112Centre Hospitalier St Anne112