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    Summary
    EudraCT Number:2021-000805-26
    Sponsor's Protocol Code Number:PSYKFORSK_MAT-MDD
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-08-04
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNorway - NOMA
    A.2EudraCT number2021-000805-26
    A.3Full title of the trial
    An Open-Label, Phase 2, Feasibility Study of Manualized MDMA-Assisted Psychotherapy in Subjects with Major Depressive Disorder
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    MDMA-Assisted Psychotherapy for the Treatment of Depression
    A.4.1Sponsor's protocol code numberPSYKFORSK_MAT-MDD
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorØstfold Hospital Trust
    B.1.3.4CountryNorway
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSouth-Eastern Norway Regional Health Authority
    B.4.2CountryNorway
    B.4.1Name of organisation providing supportMAPS PBC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationØstfold Hospital Trust
    B.5.2Functional name of contact pointTor-Morten Kvam
    B.5.3 Address:
    B.5.3.1Street AddressPeer Gynts vei 72
    B.5.3.2Town/ cityMoss
    B.5.3.4CountryNorway
    B.5.6E-mailtor-morten.kvam@so-hf.no
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product name3,4-methylenedioxymethamphetamine hydrochloride/MDMA HCl /Capsule Active substance: 42542-10-9/3,4-M
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Major Depressive Disorder
    E.1.1.1Medical condition in easily understood language
    Depression
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to evaluate the effect of MDMA-assisted psychotherapy for MDD in clinician-rated depression scores, as measured by the mean change in MADRS scores from Visit 4 (Baseline) to Visit 13 (approximately 12 weeks post Baseline). The 10-item MADRS measures severity of depression and each item is rated on a 7-point scale from 0 (no symptoms) to 6 (severe symptoms)
    E.2.2Secondary objectives of the trial
    The secondary objective of this study is to measure the feasibility of MDMA-assisted psychotherapy for treatment of MDD, as measured by the Subjective Effects scale (SE). Subjective effects on 15 items (negative mood, body perception changes, confusion, difficulty concentrating, compassion for self, compassion for others, euphoria, positive mood, intellectual efficiency, social, calmness, talkative, open to new experiences, meaningful experience, emotional distress) will be collected using a Visual Analog Scale (VAS) at three time points: initial dose of MDMA, prior to supplemental dose of MDMA and at the end of the experimental session. The subjective effects chosen for the scales are based on literature reviews of subjective effects of MDMA among healthy volunteers in controlled studies. The study is considered feasible if there is observed a significant mean change in overall SE from initial dose of MDMA to prior to supplemental dose.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Potential participants are eligible to enroll in the protocol if they:

    1. Are at least 18 years old.
    2. Are fluent in speaking and reading Norwegian.
    3. Are able to swallow pills.
    4. Agree to have study visits 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 conditions 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, implanted, intravaginal, or transdermal 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 4.1 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.

    Medical History

    10. At Screening, meet DSM-5 criteria for current MDD with a symptom duration of more than 12 weeks and less than 2 years.
    11. 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. May have asymptomatic Hepatitis C virus (HCV) that has previously undergone evaluation and treatment as needed.
    13. At Baseline, have at least moderate MDD per MADRS and symptoms in the last month constituting a MADRS Total Severity Score of 20 or greater.
    14. May have current mild alcohol or cannabis use disorder (meets 3 of 11 diagnostic criteria per DSM-5) or moderate alcohol or cannabis use disorder in early remission for the 3 months prior to enrollment (meets 5 of 11 diagnostic criteria per DSM-5).
    15. May have a history of or current Diabetes Mellitus (Type 2) if additional screening measures rule out underlying cardiovascular disease, if the condition is judged to be stable on effective management, and with approval by the Medical Monitor.
    16. May have hypothyroidism if taking adequate and stable thyroid replacement medication.
    17. May have a history of, or current, glaucoma if approval for study participation is received from an ophthalmologist.
    E.4Principal exclusion criteria
    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 MDD or any other psychiatric disorders.
    3. Are likely, in the investigator’s opinion and via observation during the Preparatory Period, to lack social support or 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
    6. Have received Electroconvulsive Therapy (ECT) within 12 weeks of enrollment.
    7. Have a history of or a current primary psychotic disorder, bipolar disorder 1 assessed via MINI and clinical interview.
    8. Have a current eating disorder with active purging assessed via MINI and clinical interview.
    9. Have current major depressive disorder with psychotic features assessed via MINI.
    10. Have a current moderate (not in early remission in the 3 months prior to enrollment; meets 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).
    11. Have an active illicit (other than cannabis) or prescription drug substance use disorder at any severity within 12 months prior to enrollment.
    12. Have current Personality Disorders assessed via SCID-5-PD.
    13. 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. Any participant presenting with the following on the Baseline C-SSRS will be excluded:
    a. Suicidal ideation score of 4 or greater within the last month of the assessment at a frequency of once a week or more
    b. Suicidal ideation score of 5 within the last 6 months of the assessment
    c. Any suicidal behavior, including suicide attempts or preparatory acts, within the last 6 months of the assessment.
    14. Would present a serious risk to others as established through clinical interview and contact with treating psychiatrist.
    15. Require ongoing concomitant therapy with a psychiatric medication with exceptions described in Protocol Section 11.0: Concomitant Medications.

    Medical History

    16. Have a history of any medical condition that could make receiving a sympathomimetic drug harmful because of increases in blood pressure and heart rate. Participants with other mild, stable chronic medical problems may be enrolled if the site physician, CI, and Medical Monitor agree the condition would not significantly increase the risk of MDMA administration or be likely to produce significant symptoms during the study that could interfere with study participation or be confused with side effects of the IMP.
    17. Have uncontrolled essential hypertension using the standard criteria of the American Heart Association (values of 140/90 milligrams of Mercury [mmHg] or higher assessed on three separate occasions).
    18. Have a history of ventricular arrhythmia at any time, other than occasional premature ventricular contractions (PVCs) in the absence of ischemic heart disease.
    19. Have Wolff-Parkinson-White syndrome or any other accessory pathway that has not been successfully eliminated by ablation.
    20. Have a history of arrhythmia, other than occasional PVCs in the absence of ischemic heart disease, within 12 months of screening. Participants with a history of atrial fibrillation, atrial tachycardia, atrial flutter or paroxysmal supraventricular tachycardia or any other arrhythmia associated with a bypass tract may be enrolled only if they have been successfully treated with ablation and have not had recurrent arrhythmia for at least one year off all antiarrhythmic drugs, and confirmed by a cardiologist.
    21. Have a marked Baseline prolongation of QT/QTc interval
    22. Have a history of additional risk factors for Torsade de pointes
    23. Require use of concomitant medications that prolong the QT/QTc interval during Experimental Sessions.
    24. Have symptomatic liver disease or have significant liver enzyme elevations.
    25. Have history of hyponatremia or hyperthermia.
    26. Weigh less than 48 kilograms (kg).
    27. Are pregnant or nursing, or are of childbearing potential and are not practicing an effective means of birth control.
    28. Have engaged in ketamine-assisted therapy or used ketamine within 12 weeks of enrollment.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Outcome Montgomery and Asberg Depression Rating Scale (MADRS).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Within 12 weeks (+/-3 weeks) of Baseline and 4 weeks (+/-2 weeks) after Experimental Session 2 (Visit 9).
    E.5.2Secondary end point(s)
    The secondary objective of this study is to measure the feasibility of MDMA-assisted psychotherapy for treatment of MDD, as measured by the Subjective Effects scale (SE). Subjective effects on 15 items (negative mood, body perception changes, confusion, difficulty concentrating, compassion for self, compassion for others, euphoria, positive mood, intellectual efficiency, social, calmness, talkative, open to new experiences, meaningful experience, emotional distress) will be collected using a Visual Analog Scale (VAS). VAS items are rated on a series of 100 mm long lines, marked from ‘not at all’ on the left to ‘extremely’ on the right. The subjective effects chosen for the scales are based on literature reviews of subjective effects of MDMA among healthy volunteers in controlled studies. The study is considered feasible if there is observed a significant mean change in overall SE from initial dose of MDMA to prior to supplemental dose.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Subjective effects on 15 items will be collected using a Visual Analog Scale (VAS) at three time points: initial dose of MDMA, prior to supplemental dose of MDMA and at the end of the experimental session.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    To measure the feasibility of MDMA-assisted psychotherapy for treatment of MDD
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Study Termination (Visit 14) will take place 2 (-1/+7) days after the final MADRS assessment (Visit 13). Participants who have withdrawn from treatment but have continued for follow-up will also complete this assessment immediately upon withdrawal.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    At Study Termination, participants will be provided with an Exit Plan. This Exit Plan will summarize treatments completed, current medications, and contact information for more information about the study if needed. Participants may request a referral for further therapeutic or medical care if appropriate. Enrolled participants who terminate the study early will be provided an Exit Plan at their last contact. Screen Failures will be provided a referral if requested.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-11-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-25
    P. End of Trial
    P.End of Trial StatusOngoing
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