ISRCTN31103960进行中（未招募）2 期
An adaptive-design, phase IIa/IIb, open-label, multiple-ascending-dose, dose-finding study to assess the safety, cardiovascular effects, pharmacokinetics and pharmacodynamic profile of 30 mg, 50 mg, and 70 mg of MSP-1014.OX in major depressive disorder (MDD) patients with partial or no response to SSRIs followed by a double-blind, randomised, placebo-controlled, proof-of-concept, efficacy and safety study of the selected dose of MSP-1014.OX in MDD patients with partial or no response to SSRIs
Clerkenwell Health0 个研究点目标入组 70 人开始时间: 2023年6月28日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
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. Aged 18 years and above
- •2. Male or female
- •3. DSM-5 defined MDD with partial response SSRI monotherapy (HAM-D score >17) or no response
- •4. Able to communicate well in English and follow study procedures
- •5. Any history of suicide attempts/suicidal ideation; the subject scores 'yes' on item 4 or 5 of the Suicidal Ideation section of the Columbia Suicidality Scale Scoring if this ideation occurred in the past 12 months, or 'yes' on any item of the Suicidal Behaviour Section, and the opinion of the investigator
- •6. Medically suitable as determined by screening including a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and blood tests
- •7. Currently taking a first course of SSRI antidepressant treatment for at least 8 weeks
排除标准
- •1. Treatment with any other antidepressant medication other than the currently prescribed SSRI antidepressant
- •2. Current or past diagnosis of schizophrenia, psychotic disorder, bipolar disorder I and II, delusional disorder, paranoid personality disorder, schizoaffective disorder, borderline personality disorder, or judged to be incompatible with establishment of rapport or safe exposure to psilocybin, as assessed through medical history and the Mini International Neuropsychiatric Inventory (MINI)
- •3. Family history of schizophrenia, schizoaffective disorder, or bipolar affective disorder
- •4. Anyone on a research study of an investigational drug or who has been on a clinical trial within 1 month of enrollment
- •5. Scores from the screener and baseline Columbia Suicide Severity Rating Scale (C-SSRS) that indicate that the participant is of clinically significant risk of suicide. A decision will be formed based on C-SSRS scores and used in combination with other clinically significant data at screening and baseline.
- •Judged to be of high suicide or self-harm risk following psychological assessment at screening or baseline.
- •6. Currently receiving psychotherapy other than that which forms far this study
- •7. Current (<1 year) alcohol or drug abuse identified as moderate or severe during screening in accordance with ICD-11 criteria, through the MINI 7.0.2
- •8. Any other reason that might compromise safe exposure to psilocin and the development of a therapeutic relationship necessary for psychological support
- •9. Previous use of psychedelics in lifetime
- •Medical Exclusion Criteria:
- •1. Females who are pregnant, breastfeeding or of childbearing potential who are unwilling or unable to use an effective form of contraception (or abstinence) for the duration of the study. Women will be required to conduct a serum pregnancy test at the in-person screening visit and a urine test prior to dosing at the drug-assisted therapy session. Male participants who do not agree to use contraception for 2 weeks following each dosing session to mitigate the risk of pregnancy will also be excluded.
- •2. A diagnosis of epilepsy or at significant risk of seizures based on medical history
- •3. Cardiovascular conditions including stroke (less than 1 year before providing informed consent [IC]), myocardial infarction (<1 year from IC), uncontrolled hypertension (blood pressure >140/90 mmHg) or clinically significant arrhythmia within 1 year of IC
- •4. Anyone who, at screening, has clinically significant findings on physical examination, including vital signs (HR below 60 or above 100 bpm, blood pressure below 90/60 or above 140/90), ECG (ST greater than 450 msec), and positive alcohol breath test
- •5. An estimated glomerular filtration rate (eGFR) of <45 ml/min/1.73 m²
- •6. Results falling above 2.5 times the upper reference level on alanine aminotransferase 0-45 IU/L, aspartate aminotransferase 0-50 IU/L, gamma-glutamyl transferase 0-70 IU/L (male), 0-40 IU/L (female)
- •7. Results falling above 1.5 times the upper reference level on bilirubin 3-20 µmol/L
- •8. Results falling above 1.0 times the upper reference level on conjugated bilirubin 0-14 µmol/L
- •9. Results falling above 1.0 times the upper reference level on alkaline phosphatase 90-300 IU/L
- •10. Any clinically significant renal, pulmonary, gastrointestinal, hepatic, or other illness that could affect the interpretation of results or be a potential health risk for the person if they were to be included in the study
- •11. Below 16 or above
研究者
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