NL-OMON52408已完成2 期
Safety and efficacy of repeated low dose D-lysergic acid diethylamide (LSD) D-tartrate (MM-120) as treatment for ADHD in adults: a multi-center, randomized, double- blind, placebo-controlled Phase 2a Proof of Concept Trial - Safety and efficacy of low dose MM120 in ADHD
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 26
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
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Ability and willingness to provide written, informed consent prior to
- •initiation of any
- •study-related procedures and to adhere to all study requirements.
- •NOTE: The subject (i.e., not a legally authorized representative) must be
- •cognitively
- •able to understand the requirements of the study and provide the informed
- •2. Age >= 18 and <= 65 years at screening.
- •3. Subjects with the diagnosis of Diagnostic and Statistical Manual of Mental
- •Disorders-
- •5 (DSM-5) ADHD, as determined by clinical evaluation and confirmed by structured
- •interview (MINI).
- •4. AISRS total score of >=26 at screening.
- •5. CGI-S score of >=4 at screening.
- •6. Must be willing to receive IMP dose twice weekly. On Day 1, the subject will
- •the clinic and must be willing to take a taxi or public transportation home or
- •accompanied by a caregiver and not drive a car, use heavy equipment, or
- •participate in
- •any other dangerous activity for the remainder of the day after receiving IMP
- •at any protocol visit after Day 1 dosing, dosing visits may occur at the
- •subject*s home
- •at the discretion of the PI, conducted by one of the study investigators or
- •delegate and
- •administered under supervision followed by the performance of the same
- •done at the clinic including safety monitoring. If early withdrawal is
- •considered due to
- •any safety issue identified, the Sponsor*s medical monitor should be notified.
- •remote visit is conducted due to any reason related to the COVID-19 pandemic,
- •notification must be sent to the Medical Monitor*s dedicated email address and
- •Safety Measures as outlined in this protocol must be followed.)
- •7. Must be willing to refrain from more than 6 standard alcoholic drinks per
- •(1 standard drink corresponds to 0.1 L wine, 0.3 L beer, or 4 cL liquor), more
- •cigarettes a day, and more than 2 cups of coffee a day throughout the study
- •period (6 weeks) and until the last study visit is complete (EoS or ET).
排除标准
- •1. Past or present diagnosis of a primary psychotic disorder or first-degree
- •relative with a
- •psychotic disorder.
- •2. Past or present bipolar disorder (DSM-5).
- •3. Other current psychiatric disorders that, in the opinion of the Investigator
- •supervisor, may confound the results of the study (e.g., obsessive-compulsive
- •dysthymic disorder, panic disorder, dissociative disorder, anorexia nervosa or
- •4. Subjects with past (> 1 month prior to the screening visit) or present
- •substance use
- •disorder (except nicotine, provided subject does not smoke more than 10
- •cigarettes a
- •5. Somatic disorders including Central Nervous System (CNS) involvement of
- •severe cardiovascular disease, untreated hypertension, severe liver disease
- •enzyme increase by more than 3x the upper limit of normal except unconjugated
- •hyperbilirubinemia due to Gilbert*s Disease, per Investigator), severely
- •impaired renal
- •function (estimated creatinine clearance < 50 mL/min by CKD-EPI formula), or
- •anything else that, in the judgment of the Investigator or medical supervisor,
- •great a potential for side effects.
- •6. Any lifetime history of suicide attempt; or recent (within 6 months prior to
- •the screening
- •visit) active suicidal thoughts or ideation (defined as a suicidal ideation
- •score of 2 or
- •greater in the Columbia-Suicide Severity Rating Scale [C-SSRS]); or endorsement
- •any suicidal behavior on the C-SSRS within the past 6 months prior to the
- •7. Likely to require psychiatric hospitalization during the course of the study.
- •8. Once consent is signed, subject not willing or able to stop any prescription
- •or nonprescription
- •ADHD medications during screening and prior to the baseline visit through
- •final study visit (EoS or ET). A list of prohibited medications is provided in
- •Appendix 1.
- •9. Plan to start, stop, or alter the use of any medications, supplements, or
- •other therapeutics
- •from Baseline until EoS or ET (see Appendix 1 for list of prohibited
- •medications).
- •10. Plan to start, stop or alter the use of psychotherapy, massage, meditation,
- •acupuncture,
- •hypnosis, yoga, or other similar therapy/activity from the time of providing
- •consent until EoS or ET.
- •11. Use of potent CYP2D6 inhibitors; moderate CYP2D6 inhibitors by Investigator
- •discretion (see Section 5.5.1.1 and Appendix 3).
- •12. Likely to need use of any psychiatric medications with the potential to
- •interpretation of study results or impact safety, at the discretion of the
- •Investigator, in
- •the 10 weeks following Baseline up to EoS or ET (see Appendix 1 for list of
- •medications).
- •13. Use of investigational medication/treatment in the past 30 days prior to
- •the screening
- •14. Subjects with a positive urine drug screen (with the exception of THC or
- •metabolites)
- 另有 9 项未显示
研究者
相似试验
进行中（未招募）
1 期
Safety and efficacy of low dose MM-120 in ADHDEUCTR2020-001098-55-NLMind Medicine, Inc.52
已完成
不适用
The efficacy of continuous administration of low-dose ketamine during elective on-pump cardiac surgery on hospital length of stay. A Randomised Controlled TrialValvular heart disease and ischaemic heart diseaseJPRN-UMIN000035517Saitama Cardiovascular and Respiratory Centre70
已完成
不适用
Evaluation of the safety and efficacy of low dose transgenic rice containing peptides from Japanese cedar pollen allergens.JPRN-UMIN000016078The Jikei University, School of Medicine21
尚未招募
3 期
Evaluation of the effectiveness of low-dose ketamine (Sub dissociative) with dexmedetomidine in controlling pain in patients with limb trauma referred to emergency departmentIRCT20220120053770N1Tehran University of Medical Sciences258
招募中
4 期
Comparison of use of Drotaverine Hydrochloride and Mefenamic Acid vs Mefenamic Acid in mensturating femalesCTRI/2015/05/005796Walter Bushnell Private Limited280