midomafetamine hydrochloride for Post-traumatic stress disorder|Treatment-refractory post-traumatic stress disorder

Inclusion criteria

• {"criterion_text":"- Are at least 18 years, at the time of signing the informed consent.\n- At Screening meet DSM-5 criteria for current PTSD with a symptom duration of at least 6 months.\n- At Screening, have a PCL-5 score of 40 or greater (i.e., moderate to severe PTSD).\n- At screening, meet criteria for treatment-refractory PTSD, defined as having had at least two evidence-based trauma focused psychotherapies of at least 10 sessions per therapy."}

Exclusion criteria

• {"criterion_text":"- Have a current Personality Disorder (except for avoidant personality disorder due to the significant overlap with PTSD)\n- Have a diagnosis of uncontrolled hypertension, defined as repeated blood pressure readings of ≥140 mmHg systolic or ≥90 mmHg diastolic.\n- Have a current eating disorder with compensatory behaviors\n- Have current major depressive disorder with psychotic features.\n- Have a history of, or a current primary psychotic disorder or bipolar affective disorder type 1\n- Have a current moderate (not in early remission in the 3 months prior to enrollment and meets at least 5 of 11 diagnostic criteria per DSM-5) or severe alcohol or cannabis use disorder within the 12 months prior to enrollment (meets at least 6 of 11 diagnostic criteria per DSM-5).\n- Have an active illicit drug (other than cannabis) or prescription drug substance use disorder at any severity within 12 months prior to enrollment.\n- Any participant presenting current serious suicide risk, as determined through psychiatric interview, responses to C-SSRS, and clinical judgment of the investigator will be excluded; however, history of suicide attempts is not an exclusion.\n- Have a marked baseline QTcF interval >450 ms demonstrated on repeated ECG assessments.\n- Have a history of any medical condition that could make receiving a sympathomimetic drug harmful because of increases in blood pressure and heart rate. This includes, but is not limited to, a history of myocardial infarction, cerebrovascular accident, heart failure, severe coronary artery disease, or aneurysm."}

Primary endpoints

• {"endpoint_text":"- Mean change in CAPS-5-R Total Severity Score from Baseline (Visit 4) to 12 weeks post Baseline (Visit 23).","definition_or_measurement_approach":"Mean change in CAPS-5-R Total Severity Score from Baseline (Visit 4) to 12 weeks post Baseline (Visit 23)."}

Secondary endpoints

• {"endpoint_text":"- Mean change in Sheehan Disability Scale (SDS) scores from Visit 4 (Baseline) to Visit 23 (12 weeks post Baseline).\n- Number, percentage and reasons for Screen Failure and Dropout.","definition_or_measurement_approach":"Mean change in SDS from Visit 4 (Baseline) to Visit 23 (12 weeks post Baseline).; Number, percentage and reasons will be reported for screen failure and dropout (counts, percentages and reasons)."}

Netherlands

Earliest CTIS Part Ii Submission Date

25-03-2024

Latest Decision Or Authorization Date

18-04-2024

Processing Time Days

24

Number Of Sites

1

Number Of Participants

20

Primary sponsor

Full Name

Arq National Psychotrauma Centre

Organisation Type

Patient organisation/association

Country Of Registered Address

Netherlands

Third parties

• {"country":"","full_name":"MAPS Publication Benefit Corporation (rebranded to Lykos Therapeutics)","duties_or_roles":"Monetary support","organisation_type":""}