An Open- Label, Phase 2, Multicenter Feasibility Study if Manualized MDMA-Assisted Psychotherapy with an fMRI sub-study Assessing Changes in Brain Activity in Subjects with Post-Traumatic Stress Disorder
- Conditions
- TraumaPosttraumatic Stress Disorder10037173
- Registration Number
- NL-OMON56347
- Lead Sponsor
- MAPS Europe B.V.
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 8
1. Are at least 18 years old
2. Are fluent in speaking and reading the predominantly used or recognized
language of the study site
3. Are able to swallow pills
4. Agree to have study visits video-recorded, including Experimental Sessions,
Independent Rater assessments, and non-drug psychotherapy sessions
5. Must provide a contact (relative, spouse, close friend or other support
person) who is willing and able to be reached by the investigators in the event
of a participant becoming suicidal or unreachable
6. Must agree to inform the investigators within 48 hours of any medical
treatments and procedures
7. If of childbearing potential, must have a negative pregnancy test at study
entry and prior to each Experimental Session, and must agree to use adequate
birth control through 10 days after 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 or double barrier contraception. Two forms of
contraception are required with any barrier method or oral hormones (i.e.
condom plus diaphragm, condom or diaphragm plus spermicide, oral hormonal
contraceptives plus spermicide or condom). Not of childbearing potential is
defined as permanent sterilization, postmenopausal, or assigned male at birth.
8. Agree to the following lifestyle modifications (described in more detail in
Section 4.3 Lifestyle Modifications): comply with requirements for fasting and
refraining from certain medications prior to Experimental Sessions, not
participate in any other interventional clinical trials during the duration of
the study, remain overnight at the study site after each Experimental Session
and be driven home after, and commit to medication dosing, therapy, and study
procedures
9. At Screening, meet DSM-5 criteria for current PTSD with a symptom duration
of 6 months or longer
10. At Screening, have at least severe PTSD symptoms in the last month based on
PCL-5 total score of 50 or greater
11. At Screening, 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
12. At Screening, may have asymptomatic Hepatitis C virus (HCV) that has
previously undergone evaluation and treatment as needed
13. At Baseline, have a confirmed diagnosis of PTSD per CAPS-5 and at least
severe symptoms in the last month constituting a CAPS-5 Total Severity Score of
35 or greater.
14. Absence of Traumatic Brain Injury
15. Absence of metal implants or metal fragments in the body
16. PTSD must be of non-dissociative sub-type
17. Absence of claustrophobia
18. Absence of tattoos in the head/neck or permanent eye makeup
1. Are not able to give adequate informed consent
2. Are currently engaged in compensation litigation whereby financial gain
would be achieved from prolonged symptoms of PTSD or any other psychiatric
disorders
3. Are likely, in the investigator*s opinion and via observation during the
Preparatory Period, to be re-exposed to their index trauma or other significant
trauma, lack social support, or lack a stable living situation
4. Have used Ecstasy (material represented as containing MDMA) more than 10
times within the last 10 years or at least once within 6 months of the first
Experimental Session; or have previously participated in a MAPS-sponsored MDMA
clinical trial
5. Have any current problem which, in the opinion of the investigator or
Medical Monitor, might interfere with participation, Psychiatric History, 1.
Have received Electroconvulsive Therapy (ECT) within 12 weeks of enrollment
2. Have a history of, or a current primary psychotic disorder, bipolar
affective disorder type 1 assessed via MINI or dissociative identity disorder
assessed via DDIS
3. Have Dissociative Subtype of PTSD assessed via CAPS-5
4. Have a current eating disorder with active purging assessed via MINI
5. Have current major depressive disorder with psychotic features assessed via
MINI
6. Meet DSM-5 criteria for current substance use disorder for alcohol or
substance use disorder other than caffeine or nicotine assessed via MINI,
AUDIT, DUDIT, drug test, and blood %carbohydrate-deficient transferrin (%CDT)
7.Have current Personality Disorders (paranoid, schizoid, antisocial,
borderline, histrionic, narcissistic, avoidant, dependent,
obsessive-compulsive) assessed via CIPD. Diagnoses will be confirmed via
clinical interview
8. 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. Any participant who is likely to require hospitalization related
to suicidal ideation and behavior, in the judgment of the investigator, will
not be enrolled
9. Would present a serious risk to others as established through clinical
interview and contact with treating psychiatrist
10. Require ongoing concomitant therapy with a psychiatric medication with
exceptions described in Section 12.0: Concomitant Medications., Medical
History, 1. Have evidence on clinical examination or history of significant
(controlled or uncontrolled) hematological, endocrine, cerebrovascular,
traumatic brain injury (TBI) with residual neurological signs or symptoms on
the physical exam, cardiovascular, coronary artery disease (using the New York
Heart Association criteria) cerebral or peripheral vascular disease, pulmonary,
renal, hepatic disease with abnormal liver enzymes (outside of the normal
clinical range), gastrointestinal, immunocompromising, or neurological disease,
including seizure disorder, or any other medical disorder judged by the
investigator to significantly increase the risk of MDMA administration
(participants with hypothyroidism who are on adequate and stable thyroid
replacement will not be excluded). Note: if participants present with a history
of glaucoma, enrollment would be allowed only with the approval of their
oph
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method