NCT06518720招募中2 期
Treatment With Psilocybin for Chronic Neuropathic Pain and Depression (TRANSCEND): An Open-Label Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Percentage of participants recruited, enrolled and retained (feasibility) and the number of serious adverse events and serious adverse drug reactions associated with administration of 25 mg of psilocybin (safety).
研究概览
简要总结
Psilocybin, the chemical component of "magic mushrooms", has been administered with psychotherapy in several randomized clinical trials (RCTs) showing large and sustained antidepressant effects.
The purpose of this study is to assess the feasibility, tolerability, and preliminary efficacy of psilocybin therapy for adults with chronic neuropathic pain and co-morbid treatment resistant depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18 to 65 years old;
- •Are outpatients;
- •Must be deemed to have capacity to provide informed consent;
- •Must sign and date the informed consent form;
- •Stated willingness to comply with all study procedures;
- •Ability to read and communicate in English, such that their literacy and comprehension is sufficient for understanding the consent form and study questionnaires, as evaluated by study staff obtaining consent;
- •Primary DSM-5 diagnosis of non-psychotic MDD, single or recurrent, based on the Structured Clinical Interview for DSM-5 (SCID-5) administered at the first screening visit;
- •Participants diagnosed with treatment-resistant depression defined as individuals with a baseline HamD-17 score > 14 and that have not responded to two or more separate trials of antidepressants at an adequate dosage and duration (an antidepressant resistance rating score of three or more is considered an adequate trial) based on the Antidepressant Treatment History Form (ATHF) (Sackeim & Sackeim, 2001); there is no upper limit on the number of treatment failures;
- •Diagnosis of chronic neuropathic pain as determined by a pain specialist and confirmed with the standardized Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) questionnaire
- •Moderate-to-severe neuropathic pain determined by Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference score of ≥ 60, as well as mean pain intensity scores ≥ 5 on a numeric rating scale
- •Previous trials of at least two medications recommended in the Canadian consensus guidelines on the management of neuropathic pain with no self-reported meaningful improvement in symptoms
- •Ability to take oral medication;
- •Individuals with an eGFR above 40mL/min/1.73m² and all blood work on clinical laboratory tests assessed as not clinically significant by study delegate physician at Screening (V1)
- •Individuals who are capable of becoming pregnant: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation;
- •Individuals who are willing to taper off current antidepressant and antipsychotic medications for a minimum of 2-weeks (or more depending on the medication) prior to Baseline (V2) and for the duration of the study and whose physician confirms that it is safe for them to do so; and
- •Agreement to adhere to Lifestyle Considerations (section 4.5) throughout study duration.
排除标准
- •Pregnant as assessed by a urine pregnancy test at Screening (V1) or individuals that intend to become pregnant during the study or are breastfeeding;
- •Treatment with another investigational drug or other intervention within 30 days of Screening (V1);
- •Have initiated psychotherapy in the preceding 12 weeks prior to Screening (V1);
- •Have a DSM-5 diagnosis of substance use disorder (recreational use of tobacco, alcohol, cannabis and prescribed opioids are permitted) within the preceding 6 months;
- •Have active suicidal ideation with intent and plan as determined by item 3 of the HamD-17;
- •Any DSM-5 lifetime diagnosis of a schizophrenia-spectrum disorder; obsessive-compulsive disorder, psychotic disorder (unless substance induced or due to a medical condition), bipolar I or II disorder, paranoid personality disorder, borderline personality disorder, or neurocognitive disorder as determined by medical history and the SCID-5 clinical interview;
- •Any first-degree relative with a diagnosis of schizophrenia-spectrum disorder; psychotic disorder (unless substance-induced or due to a medical condition); or bipolar I or II disorder as determined by the family medical history form and discussions with the participant;
- •Presence of a relative or absolute contraindication to psilocybin, including a drug allergy, recent stroke history, uncontrolled hypertension, low or labile blood pressure, recent myocardial infarction, cardiac arrhythmic, severe coronary artery disease, or moderate to severe renal or hepatic impairment.
- •Presence of baseline prolonged QTc or Torsade de Pointes as measured by the ECG or a history of long QTc syndrome or related risk factors;
- •Individuals who are currently taking methadone, buprenorphine or > 100 milligrams of morphine (or morphine equivalents).
- •Any other clinically significant physical illness including chronic infectious diseases or any other major concurrent illness that, in the opinion of the investigator, may interfere with the interpretation of the study results or constitute a health risk for the participant if they take part in the study.
研究组 & 干预措施
Psilocybin (25 mg)
Experimental
One capsule of psilocybin 25 mg will be taken orally with a glass of water.
干预措施: Psilocybin 25 mg (Drug)
结局指标
主要结局
Percentage of participants recruited, enrolled and retained (feasibility) and the number of serious adverse events and serious adverse drug reactions associated with administration of 25 mg of psilocybin (safety).
时间窗: 24 Months
Percentage of participants recruited, enrolled and retained over 24 months. Number of serious adverse events and serious adverse drug reactions associated with psilocybin 25 mg.
次要结局
- Change in the Montgomery-Åsberg Depression Rating Scale (MADRS) from Baseline to 1-week post-treatment.(Baseline (Visit 2, Day 0) to 1-week post-treatment (Visit 4, Day 7).)
研究者
Ishrat Husain
Senior Scientist, Temerty Centre for Therapeutic Brain Intervention
Centre for Addiction and Mental Health
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Feasibility, Clinical Effects, and Safety of Psilocybin-assisted Psychotherapy for Treatment-resistant OCDObsessive-Compulsive DisorderNCT06299319Centre for Addiction and Mental Health10
已完成
2 期
Does Psilocybin Require Psychedelic Effects to Treat Depression?Treatment-resistant DepressionNCT05710237Centre for Addiction and Mental Health41
招募中
1 期
Psilocybin for hospitalized patients with treatment-resistant depressiotreatment-resistant depressionCTIS2022-501857-35-00niversitair Ziekenhuis Gent100
已完成
2 期
Psilocybin-assisted psychotherapy for the treatment of depression and anxiety associated with life-threatening illnessDepression in terminal illness (any palliative condition including malignant and non-malignant terminal illnesses)Anxiety in terminal illness (any palliative condition including malignant and non-malignan terminal illnesses)Mental Health - AnxietyMental Health - DepressionCancer - Any cancerACTRN12619001225101St. Vincent's Hospital Melbourne35
招募中
2 期
Psilocybin for Enhanced Analgesia in Chronic NEuropathic PAINChronic Neuropathic PainPain ManagementNCT06731335Unity Health Toronto30