post-traumatic stress disorder (PTSD)
Conditions
Interventions
Product Name: 3,4-methylenedioxymethamphetamine hydrochloride
Product Code: MDMA HCl
Pharmaceutical Form: Capsule
INN or Proposed INN: Midomafetamine
CAS Number: 42542-10-9
Current Sponsor code: MDMA
Sponsors
MAPS Europe B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Are at least 18 years old - Are fluent in speaking and reading the predominantly used orrecognized language of the study site - Are able to swallow pills - Agree to have study visits video-recorded, including ExperimentalSessions, Independent Rater assessments, and non-drug psychotherapysessions - Must provide a contact (relative, spouse, close friend or other supportperson) who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable - Must agree to inform the investigators within 48 hours of any medicaltreatments and procedures - People able to become pregnant (PABP) (i.e.,assigned female at birth,fertile, following menarche and until becoming post-menopausal unless permanently sterile), must havea highly sensitive negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate birth control through 10 daysafter the last Experimental Session. Adequate birth control methods include intrauterine device (IUD), injected or implanted hormonal methods, abstinence, oral hormones plus a barrier contraception,vasectomized sole partner. Not of childbearing potential is defined as permanent sterilization or assigned male at birth. - Agree to the following lifestyle modifications: comply withrequirements for fasting and refraining from certain medications prior to Experimental Sessions, not enroll in any other interventional clinicaltrials during the duration of the study, remain overnight at the study siteafter each Experimental Session and be driven home after, and commit to medication dosing, therapy, and study procedures. - At Screening, meet DSM-5 criteria for current PTSD - May have well-controlled hypertension that has been successfully treated with anti-hypertensive medicines, if they pass additional screening to rule out underlying cardiovascular disease - May have asymptomatic Hepatitis C virus (HCV) that has previously undergone evaluation and treatment as needed. 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 32 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: - Are not able to give adequate informed consent - Have any current problem which, in the opinion of the investigator orMedical Monitor, might interfere with participation - Would present a serious risk to others as established through clinicalinterview and contact with treating psychiatrist - Require ongoing concomitant therapy with a psychiatric medicationwith exceptions described in the protocol. - Weigh less than 48 kilograms (kg) - Are pregnant or nursing or are of childbearing potential and are notpracticing an effective means of birth control.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The overall objective of this study is to use standard clinical measures to explore the safety and effects of open-label manualized MDMA-assisted psychotherapy with a flexible dose of MDMA in participants with severe PTSD, and to serve as an opportunity for supervision of therapy teams selected to conduct Phase 3 MDMA-assisted psychotherapy research. The primary objective of this study is to evaluate the effect of MDMA-assisted psychotherapy on PTSD, as measured by the estimand of change in CAPS-5 Total Severity Score from Baseline to 13 weeks post Baseline. ;Secondary Objective: The secondary objective is to evaluate the effectiveness of MDMA-assisted psychotherapy for PTSD in clinician-rated functional impairment, as measured by the mean change in Sheehan Disability Scale (SDS) item scores from Baseline) to 13 weeks post-baseline. Safety Objective The overall safety objective is to assess severity, incidence and frequency of AEs, AEs of Special Interest (AESIs), and Serious Adverse Events (SAEs), concomitant medication use, suicidal ideation and behavior, and vital signs to support the package insert for MDMA-assisted psychotherapy. ;Primary end point(s): The primary objective of this study is to evaluate the effectiveness of MDMA-assisted psychotherapy for treatment of PTSD, as measured by the estimand of change in CAPS-5 Total Severity Score from Baseline to 13 weeks post Baseline. ;Timepoint(s) of evaluation of this end point: 13 weeks post baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary objective is to evaluate the effectiveness of MDMA-assisted psychotherapy for PTSD in clinician-rated functional impairment, as measured by the mean change in Sheehan Disability Scale (SDS) item scores from Baseline) to 13 weeks post baseline. ;Timepoint(s) of evaluation of this end point: 13 weeks post baseline | — |
Countries
Czechia, Czech Republic, Germany, Netherlands, Norway, Portugal, Spain, United Kingdom
Contacts
Public ContactFabiana da Silva Alves
MAPS Europe B.V.
Outcome results
None listed