NCT01458327

Additional MDMA-assisted Therapy for People Who Relapsed After MDMA-assisted Therapy Trial

Completed Phase 2 Results posted Last updated 24 January 2024

What this trial tests

Phase 2 trial testing Midomafetamine in Posttraumatic Stress Disorder in 3 participants. Completed in 27 June 2014.

Timeline

15 December 2010

Primary endpoint
27 June 2014

27 June 2014

Quick facts

Lead sponsor	Lykos Therapeutics
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	3
Start date	15 December 2010
Primary completion	27 June 2014
Estimated completion	27 June 2014
Sites	1 location across United States

Drugs / interventions tested

• Midomafetamine — full drug profile →
• Therapy

Conditions studied

• Posttraumatic Stress Disorder — all drugs for Posttraumatic Stress Disorder →

Sponsor

Lykos Therapeutics — full company profile →

Who can join

18 and older, any sex, with Posttraumatic Stress Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Baseline Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) Primary · Less than 4 weeks before first experimental session

The CAPS-IV is a structured clinical interview designed to assess the symptoms and severity of PTSD. The CAPS-IV provides a means to evaluate the frequency and intensity dimensions of each symptom, the impact of symptoms on the patient's social and occupational functioning, the overall severity of the symptom complex, global improvement since baseline, and the validity of the ratings obtained. Total severity scores range from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.

Group	Value	95% CI
3,4-methylenedoxymethamphetamine (MDMA)-Assisted Therapy	93.3	± 1.53

Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) at 2-month Follow-up Primary · 2 months post experimental session

The CAPS-IV is a structured clinical interview designed to assess the symptoms and severity of PTSD. The CAPS-IV provides a means to evaluate the frequency and intensity dimensions of each symptom, the impact of symptoms on the patient's social and occupational functioning, the overall severity of the symptom complex, global improvement since baseline, and the validity of the ratings obtained. Total severity scores range from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.

Group	Value	95% CI
3,4-methylenedoxymethamphetamine (MDMA)-Assisted Therapy	31.3	± 12.01

Clinician-Administered PTSD Scale (CAPS-IV)) at 12-month Follow-up Primary · 12 months post experimental session

The Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-IV. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.

Group	Value	95% CI
3,4-methylenedoxymethamphetamine (MDMA)-Assisted Therapy	52.7	± 39.63

Change in Clinician-Administered PTSD Scale (CAPS-IV) From Baseline to 2-month Follow-up Primary · Baseline to 2 months post experimental session

The Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-IV. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.

Group	Value	95% CI
3,4-methylenedoxymethamphetamine (MDMA)-Assisted Therapy	-62.0	± 12.53

Change in Clinician-Administered PTSD Scale (CAPS-IV) From Baseline to 12-month Follow-up Primary · Baseline to 12 months post experimental session

The Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-IV. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.

Group	Value	95% CI
3,4-methylenedoxymethamphetamine (MDMA)-Assisted Therapy	-40.7	± 40.27

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse Events were collected throughout the study for approximately 12 months during Experimental Session (Visit 2), Integrative Sessions (Visit 3-5), 2-month Follow-up (Visit 6), and 12-month Follow-up (Visit7). AE's that occurred prior to date of first experimental dose were not reported.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

3,4-methylenedoxymethamphetamine (MDMA)-Assisted Therapy

Serious: 1/3 (33%)

Deaths: 0/3

Serious adverse events (1 terms)

Reaction	System	3,4-methylenedoxymethamphe…
Suicidal ideation	Psychiatric disorders	—

Other adverse events (4 terms — click to expand)

Reaction	System	3,4-methylenedoxymethamphe…
Major depression	Psychiatric disorders	—
Drug abuse	Psychiatric disorders	—
Dissociation	Psychiatric disorders	—
Upper respiratory tract infection	Infections and infestations	—

Most-reported serious reactions: Suicidal ideation.

Data from ClinicalTrials.gov NCT01458327 adverse events section.

Sponsor's own description

This study will consist of a single session of MDMA-assisted therapy with a full dose of MDMA for people who took part in a study of MDMA-assisted therapy in people with posttraumatic stress disorder (PTSD) whose PTSD symptoms returned to higher levels at least a year after the first MDMA sessions. The single session will be performed by the same pair of therapists who performed the sessions in the first study. People will have a preparatory session, the MDMA-assisted session and three non-drug sessions afterward. Their PTSD symptoms and symptoms of depression will be measured at the start of this study and two and 12 months after the session.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.