Clinical TrialMajor Depressive Disorder (MDD)MDMACompleted

An Open-Label, Phase 2, Feasibility Study of Manualized MDMA-Assisted Psychotherapy in Subjects with Major Depressive Disorder

Open-label Phase II feasibility study (n=12) of manualized MDMA-assisted psychotherapy for moderate-to-severe MDD, with up to two experimental oral MDMA sessions (supplemental dose allowed) and clinician-rated MADRS change at ~12 weeks as primary outcome.

Target Enrollment
12 participants
Study Type
Phase II interventional
Design
Non-randomized

Detailed Description

Open-label, single-site Phase 2 feasibility trial in Norway testing manualized MDMA-assisted psychotherapy in adults with current major depressive disorder (MADRS ≥20). Twelve participants receive preparatory psychotherapy, up to two experimental oral MDMA sessions (with a possible supplemental dose), and integration sessions.

Primary endpoint is change in MADRS from baseline to approximately 12 weeks; secondary outcomes assess feasibility and subjective effects using a 15-item Visual Analogue Scale at baseline, prior to supplemental dose, and at session end. Safety procedures include medical screening, overnight observation and exclusion of participants at significant suicide risk.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Therapeutic Protocol

maps

Study Arms & Interventions

MDMA-assisted psychotherapy

experimental

Open-label manualized MDMA-assisted psychotherapy with up to two experimental sessions and possible supplemental dose.

Interventions

  • MDMA
    via Oral• single session; supplemental dose allowed

    MDMA HCl capsules per protocol; psychotherapy provided during sessions.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Are at least 18 years old; fluent in Norwegian; able to swallow pills; agree to have study visits recorded (including Experimental Sessions, Independent Rater assessments, and non-drug psychotherapy sessions); provide a contact person reachable if participant becomes suicidal or unreachable; agree to inform investigators within 48 hours of any medical conditions/procedures; if of childbearing potential have negative pregnancy test at entry and prior to each Experimental Session and agree to use adequate contraception through 10 days after last Experimental Session (two forms required with barrier methods); agree to lifestyle modifications (fasting, medication restrictions), remain overnight after Experimental Sessions and be driven home; meet DSM-5 criteria for current MDD with symptom duration >12 weeks and <2 years; may have well-controlled hypertension if cleared by screening; may have asymptomatic HCV if evaluated/treated; at Baseline have MADRS total ≥20; may have current mild alcohol or cannabis use disorder or moderate alcohol/cannabis use disorder in early remission; may have history/current type 2 diabetes if stable and cleared; may have stable hypothyroidism on replacement therapy; may have history/current glaucoma if ophthalmologist approval obtained.

Exclusion Criteria

  • Unable to give adequate informed consent; engaged in compensation litigation related to prolonged symptoms; lack social support or stable living situation; used Ecstasy/MDMA >10 times in last 10 years or any in last 6 months or previously participated in a MAPS-sponsored MDMA trial; any condition that might interfere with participation in investigator/Medical Monitor opinion; ECT within 12 weeks; history/current primary psychotic disorder or bipolar I; current eating disorder with active purging; current MDD with psychotic features; current moderate/severe alcohol or cannabis use disorder (not in early remission) within 12 months; active illicit (other than cannabis) or prescription drug SUD within 12 months; current Personality Disorders per SCID-5-PD; current serious suicide risk (see suicidalityDetails) (history of attempts not exclusion unless recent/high risk); presenting serious risk to others; require ongoing concomitant psychiatric medication (exceptions per protocol); medical conditions increasing risk from sympathomimetic effects (e.g., uncontrolled cardiovascular disease); uncontrolled essential hypertension; history of ventricular arrhythmia (other than occasional PVCs) or WPW unless ablated and stable; marked baseline QT/QTc prolongation or additional risk factors for Torsade de pointes; require medications that prolong QT/QTc during Experimental Sessions; symptomatic liver disease or significant liver enzyme elevations; history of hyponatraemia or hyperthermia; weigh <48 kg; pregnant or nursing or of childbearing potential not using effective contraception; engaged in ketamine-assisted therapy or used ketamine within 12 weeks.

Study Details

  • Status
    Completed
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment12 participants
  • Timeline
    Start: 2021-11-19
    End: 2023-12-12
  • Compound
    MDMA
  • Topic
    Major Depressive Disorder (MDD)

Locations

Norway

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