EUCTR2021-006233-19-IE招募中1 期
Efficacy and safety of COMP360 psilocybin therapy in anorexia nervosa: a proof-of-concept study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Signed ICF.
- •2. Any sex and aged 18 years or above at screening.
- •3. Meeting criteria for AN either restrictive or binge-purging type, according to the DSM-5, based on medical records, clinical assessment, BMI, documented completion of MINI 7.0.2, and EDE at screening.
- •4. Have successfully discontinued all prohibited medications for a period of at least two weeks prior to baseline. For fluoxetine (Prozac), immediate cessation at screening period visit 1a followed by at least four weeks of washout will be required prior to baseline.
- •5. Has a history of disordered eating with duration of at least 3 years prior to screening, that is consistent with AN.
- •6.BMI =15 kg/m2 and =20 kg/m2. For participants with a BMI <16 kg/m2 and >18.5 kg/m2 at screening, the approval from the Medical Monitor will be required. Any participant with a BMI >18.5 kg/m2 must meet all of criteria for AN except that, despite significant weight loss, the individual’s weight is within or above the normal range.
- •7. Have a CGI-S score=4, corresponding to at least moderately ill, at both screening and baseline.
- •8. Being otherwise medically stable at screening determined by clinical interview, clinical laboratory values, vital signs, ECG, and medical history.
- •9. Have at least one documented prior attempt at treatment in the past 3 years.
- •10. Agree to have the study team maintain contact with an identified companion for the duration of the study.
- •11. Able to complete all protocol required assessment tools without any assistance or alteration to the copyrighted assessments, and to comply with all study visits.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 48
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •Exclusion of potentially confounding psychiatric diseases and therapies:
- •1. Prior or ongoing bipolar disorder, any psychotic disorder, including schizophrenia, schizophreniform disorder, schizoaffective disorder, brief psychotic disorder, antisocial personality disorder, or any serious psychiatric comorbidity as assessed by medical history and a structured clinical interview (MINI 7.0.2).
- •2. Prior or ongoing paranoid, schizoid, schizotypal, histrionic, narcissistic personality disorder based on medical history and clinical judgment.
- •3. Prior psychotic episode (including substance induced or due to a medical condition) as documented in medical history, reported by the participant, or determined according to clinical judgment.
- •4. Family history of psychosis in a biological first-degree relative, as reported by the participant
- •5. Borderline personality disorder as demonstrated by medical history, the MINI Plus — BPD and clinical judgment.
- •6. Significant suicide risk as defined by (1) suicidal ideation as endorsed on items 4 or 5 on the C-SSRS within the past year, at screening or at baseline, or; (2) suicidal behaviours within the past year or; (3) clinical assessment of significant suicidal risk during participant interview.
- •7. Current (within last year) alcohol or substance use disorder as informed by the DSM-5 assessed via the MINI 7.0.2, and urine toxicology at screening.
- •8. Other personal circumstances and behaviour judged to be incompatible with establishment of rapport or safe exposure to psilocybin.
- •9. Exposure to psilocybin, or any other psychedelics, such as ayahuasca, mescaline, LSD, or peyote within the past year.
- •General medical exclusion criteria:
- •1. A participant reported average weight loss (>1 kg per week) in the 4 weeks prior to screening.
- •2. Significant weight loss (>1 kg per week) measured between screening and baseline.
- •3. Clinically significant abnormal findings, on the physical examination at screening and baseline.
- •4. A participant who is pregnant, nursing, or planning to conceive. Males and females who engage in sexual intercourse which could result in pregnancy, must agree to use a highly effective contraceptive method (as listed in Protocol Section 10.1.2) throughout their participation in the study. Participants of childbearing potential must have a negative serum pregnancy test at screening, and negative urine pregnancy test at baseline. Participants should be informed not to donate sperm during the study period or for at least three months after COMP360 administration.
- •5. Clinically significant laboratory test abnormalities at screening including full blood count (hemoglobin <10 g/dL), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) = 3 × upper limit of normal (ULN), total bilirubin = 1.5 × ULN or alkaline phosphatase = 2.5 × ULN, reduced glomerular filtration rate (GFR< 60) or creatinine > 1.5 × ULN.
- •6. Abnormal serum potassium levels (<3.6 mmol/L) at screening to exclude risk of hypokalaemia.
- •7. Gilbert’s syndrome.
- •8. Cardiovascular conditions: recent stroke (<1 year prior to signing ICF), recent myocardial infarction (<1 year prior to signing ICF), uncontrolled hypertension (blood pressure >140/90 mmHg), bradycardia (<50 beats per minute [bpm]), elongated corrected QT interval by Fredericia (QTcF; >450 ms for men and >470 ms for women), clinically significant arrhythmia (<1 year prior to signing the ICF) based on vital signs and ECG measurement at screening and baseline and medical h
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