SYF7b80a75853f648cba548f481346af915

Not Yet RecruitingPhase 2

A Randomized, Delayed-Treatment Controlled, Phase 2 Pilot St...

Ostfold Hospital Trust Source

Ostfold Hospital Trust

CTIS (EMA)

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Study Type

interventional

Reported enrollment (type unavailable)

N/A

Locations

1 country

Sites

1

Brief Summary

The primary objective of this randomized delayed-treatment controlled pilot study is to evaluate the feasibility and safety of MDMA-assisted therapy with individualized flexible dosing in participants aged 18–25 years with chronic treatment-resistant MDD.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: not yet recruiting
Reported enrollment (type unavailable): Not reported
Study completion date: Not reported
Date not reported
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
May 27, 2026
Actual (reported)

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (2)

Recruitment and retention
Moderate to severe adverse events, Adverse event of special interest and Serious adverse events

Secondary Outcomes (2)

Between-group difference in depression severity
Between-group difference in functional impairment severity

Interventions

MidomafetamineType not reported

Eligibility Criteria

Sexall

Age GroupsAdult (18-64)

You may qualify if:

Are 18 – 25 years old
Are fluent in speaking and reading Norwegian. This criterion is based on the need to ensure effective communication and the development of a strong therapeutic alliance. Limited language proficiency may hinder the therapist’s ability to provide adequate support during and after the MDMA-assisted sessions.

Sponsors & Collaborators

Ostfold Hospital Trust
Type not reportedlead

Study Sites (1)

Sykehuset Ostfold HF

Graalum, 1714, Norway

Ole Andreassen+4799038893 ole.andreassen@medisin.uio.no

Central Study Contacts

Tor-Morten Kvam

+4799033605 Tor-Morten.Kvam@so-hf.no

Study Design

Study Type: interventional
Phase: phase 2

Study Record Dates

First Submitted

May 27, 2026

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2024-520319-42-01
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-30 06:08:33 UTC

Documents

D5_Clinician facing material Maudsley EMPATHY

NCT06836063

Study to Evaluate Efficacy and Safety of Ropanicant in MDD Patients

Phase 2Completed

NCT00048204

A Study Of A New Medicine (GW597599B) For The Treatment Of Major Depressive Disorder

Phase 2Completed

NCT00057213

An 8 Week Study Of Depression In Adults Diagnosed With Major Depressive Disorder

Phase 2Completed

NCT03642964

A Study in Patients With Major Depressive Disorder

Phase 2Unknown

NCT06126497

Study Evaluating Safety and Efficacy of Ropanicant in MDD Patients

Phase 2Completed

NCT00413023

Study Of The Effects Of A New Antidepressant Therapy In Patients With Major Depressive Disorder (MDD)

Phase 2Completed

Are able to swallow pills

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.

Must agree to inform the investigators within 48 hours of any medical conditions and procedures.

Women of childbearing potential (WOCBP) as defined in Section 10.4.1 must have a negative pregnancy test at study entry and prior to each Dosing Session and must agree to use adequate birth control through 30 days after the last Dosing Session. Only highly effective contraception methods are permitted in this trial. See section 10.4.2 for a list of these methods.

Agree to the following lifestyle modifications (described in more detail in Section 5.3 Lifestyle Modifications): comply with requirements for fasting and refraining from certain medications prior to Dosing Sessions, not participate in any other interventional clinical trials during the duration of the study, and be driven home after the Dosing sessions, and commit to medication dosing, therapy, and study procedures. Must provide a contact (relative, spouse, close friend or other support person) who is willing to fill out relevant questionnaires.

At Screening, meet DSM-5 criteria for moderate to severe MDD without psychotic features (MADRS ≥ 20) that presents as chronic depression (persistent symptoms for ≥ 2 years). The participant must have experienced failure of at least two distinct therapeutic interventions for depression over their lifetime, including both pharmacological treatments (antidepressant medications) and psychotherapy. At least one of the failed treatments must have been a course of psychotherapy. Additionally, at least one treatment failure must be related to the current depressive episode. Only treatments administered at an adequate dose, frequency, and duration—provided they were tolerable—will be considered valid. Notably, a psychotherapy course lasting 2 years or longer will be counted as two separate therapeutic approaches.

You may not qualify if:

Are not able to give adequate informed consent
Clinically significant dissociative symptomatology
CYP2D6 poor metabolizer
Are currently engaged in compensation litigation whereby financial gain would be achieved from prolonged symptoms of MDD or any other psychiatric disorders
Are likely, in the investigator’s opinion and via observation during screening and preparatory period to lack sufficient internal and/or external resources and/or an ability to form a therapeutic alliance. This includes, but is not limited to, an understanding of and willingness to allow and explore inner states, enough social support and a reasonable stable living situation.
Have used MDMA/ecstasy previously
Have any current problem which, in the opinion of the investigator or Site physician, might interfere with participation
Previous treatment with Electroconvulsive Therapy (ECT) or ketamine
Previous experience with psychedelic-assisted therapy
Have a history of or a current primary psychotic disorder, or bipolar disorder 1 assessed via MINI and clinical interview
Autism spectrum disorder
Have a current eating disorder with active purging assessed via MINI (at screening) and clinical interview.
Have 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).
Have a history of ventricular arrhythmia at any time, other than occasional premature ventricular contractions (PVCs) in the absence of ischemic heart disease.
Have Wolff-Parkinson-White syndrome or any other accessory pathway that has not been successfully eliminated by ablation
+21 more criteria

Contact the study team to confirm eligibility.

D4_Subject facing material Bergen insomnia scale EMPATHY

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D4_Subject facing material EBI EMPATHY

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D4_Subject facing material GAD-7 EMPATHY

D5_Clinician facing material MADRS EMPATHY

D4_Subject facing material IHI-2D-VAS baseline versjon

D4_Subject facing material WEMWBS EMPATHY

D4_Subject facing material LTFU V1 22apr2025_EMPATHY

D4_Subject facing material SDS_27Feb2018_EMPATHY

D4_Subject facing material BDI-II MAT-MDD

D4_Subject facing material NEQ-20_25Oct2017_EMPATHY

D4_Subject facing material EQ-5D-5L EMPATHY

D4_Subject facing material WAI-T EMPATHY

D4_Subject facing material 10-item VAS EMPATHY V1_12Feb2026

D4_Subject facing material IMI_norsk_05mar2025 EMPATHY

D4_Subject facing material PIS EMPATHY

D4_Subject facing material Modified Scale for Suicidal Ideation _MSSI_1991_EMPATHY

D5_Clinician facing material C-SSRS-Baseline-Screening EMPATHY

D4_Subject facing material MPFI-24 EMPATHY

D4_Subject facing material SCS EMPATHY

D4_Subject facing material TAS_21MAR2013 NO_EMPATHY

D5_Clinician facing material MINI 13Aug2018_EMPATHY

D4_Subject facing material DES EMPATHY

D1_Protocol_2024-520319-42-01_Redacted

D1_Protocol synopsis_2024-520319-42-01

K1_Recruitement arrangements

L1_Main ICF

L1_Optional sub-study ICF

Locations

NO(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations