High-Intensity Inpatient MDMA-Assisted Psychotherapy for Treatment-Refractory Posttraumatic Stress Disorder: An Open-Label Pilot Study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Arq National Psychotrauma Centre

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Psychiatry and Psychology [F] - Mental Disorders [F03]

Trial duration

16 May 2025 → ongoing

Decision date (initial)

2024-04-18

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

MAPS Publication Benefit Corporation (rebranded to Lykos Therapeutics)

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Others, Efficacy, Therapy

The primary objective of this study is to evaluate the effect of MDMA-assisted therapy on PTSD symptoms.

Secondary objectives 2

1. Evaluate the effect of MDMA-assisted therapy for PTSD on clinician-rated functional impairment.
2. Evaluate the feasibilty of a high-intensity inpatient approach to MDMA-assisted therapy.

Conditions and MedDRA coding

posttraumatic stress disorder

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Are at least 18 years, at the time of signing the informed consent.
2. At Screening meet DSM-5 criteria for current PTSD with a symptom duration of at least 6 months.
3. At Screening, have a PCL-5 score of 40 or greater (i.e., moderate to severe PTSD).
4. 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 10

1. Have a current Personality Disorder (except for avoidant personality disorder due to the significant overlap with PTSD)
2. Have a current eating disorder with compensatory behaviors
3. Have current major depressive disorder with psychotic features.
4. Have a history of, or a current primary psychotic disorder or bipolar affective disorder type 1
5. 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).
6. Have an active illicit drug (other than cannabis) or prescription drug substance use disorder at any severity within 12 months prior to enrollment.
7. 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.
8. Have a marked baseline QTcF interval >450 ms demonstrated on repeated ECG assessments.
9. 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.
10. Have a diagnosis of uncontrolled hypertension, defined as repeated blood pressure readings of ≥140 mmHg systolic or ≥90 mmHg diastolic.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Mean change in CAPS-5-R Total Severity Score from Baseline (Visit 4) to 12 weeks post Baseline (Visit 23).

Secondary endpoints 2

1. Mean change in Sheehan Disability Scale (SDS) scores from Visit 4 (Baseline) to Visit 23 (12 weeks post Baseline).
2. Number, percentage and reasons for Screen Failure and Dropout.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Arq National Psychotrauma Centre

Sponsor organisation

Arq National Psychotrauma Centre

Address

Nienoord 5

City

Diemen

Postcode

1112 XE

Country

Netherlands

Scientific contact point

Organisation

Arq National Psychotrauma Centre

Contact name

Erwin Krediet

Public contact point

Organisation

Arq National Psychotrauma Centre

Contact name

Erwin Krediet

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Unexpected events 1 · Art. 53 CTR

Note: SUSARs are reported via EudraVigilance, not CTIS — events shown here are CTIS-public notifications only.

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 28 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications