Trial Outcomes & Findings for MDMA-Assisted Psychotherapy in People With Posttraumatic Stress Disorder (NCT NCT00090064)

Last Updated: 2025-06-06

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

23 participants

Primary outcome timeframe

Baseline to 2 months post second experimental session

Results posted on

2025-06-06

Participant Flow

Participants were recruited via letters to psychotherapists and internet advertisements.

Participant milestones

Participant milestones
Measure	MDMA-assisted Therapy Participants will receive 125 mg MDMA followed 2 to 2.5 hours later by 62.5 mg MDMA during two 8-hour long blinded therapy sessions.	Placebo With Therapy Participants will receive an initial dose of 125 mg placebo orally followed 2 to 2.5 hours later by a second dose of 62.5 mg placebo during two 8-hour long blinded therapy sessions.
Overall Study STARTED	15	8
Overall Study COMPLETED	13	8
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

MDMA-Assisted Psychotherapy in People With Posttraumatic Stress Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MDMA-assisted Therapy n=15 Participants Participants will receive 125 mg MDMA followed 2 to 2.5 hours later by 62.5 mg MDMA during two 8-hour long blinded therapy sessions.	Placebo With Therapy n=8 Participants Participants will receive an initial dose of 125 mg placebo orally followed 2 to 2.5 hours later by a second dose of 62.5 mg placebo during two 8-hour long blinded therapy sessions.	Total n=23 Participants Total of all reporting groups
Age, Continuous	40.5 years STANDARD_DEVIATION 7.4 • n=5 Participants	40.8 years STANDARD_DEVIATION 7.0 • n=7 Participants	40.6 years STANDARD_DEVIATION 70.1 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	7 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	14 Participants n=5 Participants	8 Participants n=7 Participants	22 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 2 months post second experimental session

Population: Intent-to-treat

Outcome measures

Outcome measures
Measure	MDMA-assisted Therapy n=12 Participants Participants will receive an initial dose of 125 mg MDMA orally followed 2 to 2.5 hours later by a second dose of 62.5 mg MDMA during two 8-hour long blinded therapy sessions. 3,4-methylenedioxymethamphetamine: 125 mg MDMA followed by a supplemental half-dose of 62.5 mg MDMA Therapy: Non-directive therapy provided by a team of two co-therapists	Placebo With Therapy n=8 Participants Participants will receive an initial dose of 125 mg placebo orally followed 2 to 2.5 hours later by a second dose of 62.5 mg placebo during two 8-hour long blinded therapy sessions. Lactose placebo pill: 125 mg placebo followed by a supplemental half-dose of 62.5 mg placebo Therapy: Non-directive therapy provided by a team of two co-therapists
Change in Clinician-Administered PTSD Scale (CAPS-IV) From Baseline to 2-month Follow-up	-55.2 score on a scale Standard Deviation 33.54	-20.5 score on a scale Standard Deviation 20.47

SECONDARY outcome

Timeframe: Baseline to 2 months post second experimental session

Population: Intent-to-treat

The Impact of Events Scale Revised (IES-R) is a 22-item self-report measure (for DSM-IV) designed to measure the extent to which a given stressful life event produces subjective distress. Each item corresponds directly to 14 of the 17 DSM-IV symptoms of PTSD and is rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely") for the extent to which the item was true for the participant during the past seven days. The IES-R yields a total score ranging from 0 to 88 with higher scores indicated greater distress.

Outcome measures

Outcome measures
Measure	MDMA-assisted Therapy n=13 Participants Participants will receive an initial dose of 125 mg MDMA orally followed 2 to 2.5 hours later by a second dose of 62.5 mg MDMA during two 8-hour long blinded therapy sessions. 3,4-methylenedioxymethamphetamine: 125 mg MDMA followed by a supplemental half-dose of 62.5 mg MDMA Therapy: Non-directive therapy provided by a team of two co-therapists	Placebo With Therapy n=7 Participants Participants will receive an initial dose of 125 mg placebo orally followed 2 to 2.5 hours later by a second dose of 62.5 mg placebo during two 8-hour long blinded therapy sessions. Lactose placebo pill: 125 mg placebo followed by a supplemental half-dose of 62.5 mg placebo Therapy: Non-directive therapy provided by a team of two co-therapists
Change in Impact of Events Scale Revised (IES-R) From Baseline to 2-month Follow-up	-29.7 score on a scale Standard Deviation 21.3	-12.9 score on a scale Standard Deviation 15.00

Adverse Events

MDMA-assisted Therapy

Serious events: 2 serious events

Other events: 13 other events

Deaths: 0 deaths

Placebo With Therapy

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

SRRs: MDMA-assisted Therapy

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

SRRs: Placebo With Therapy

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MDMA-assisted Therapy n=15 participants at risk Participants will receive 125 mg MDMA followed 2 to 2.5 hours later by 62.5 mg MDMA during two 8-hour long blinded therapy sessions.	Placebo With Therapy n=8 participants at risk Participants will receive an initial dose of 125 mg placebo orally followed 2 to 2.5 hours later by a second dose of 62.5 mg placebo during two 8-hour long blinded therapy sessions.	SRRs: MDMA-assisted Therapy n=15 participants at risk Spontaneously reported reactions (SRRs) collected on the day of experimental sessions and 7 days after.	SRRs: Placebo With Therapy n=8 participants at risk Spontaneously reported reactions (SRRs) collected on the day of experimental sessions and 7 days after.
Musculoskeletal and connective tissue disorders Clavicle fracture	6.7% 1/15 • On or after first day of study intervention through to follow-up visit (approximately 7 months)	0.00% 0/8 • On or after first day of study intervention through to follow-up visit (approximately 7 months)	0.00% 0/15 • On or after first day of study intervention through to follow-up visit (approximately 7 months)	0.00% 0/8 • On or after first day of study intervention through to follow-up visit (approximately 7 months)
Nervous system disorders Syncope	6.7% 1/15 • On or after first day of study intervention through to follow-up visit (approximately 7 months)	0.00% 0/8 • On or after first day of study intervention through to follow-up visit (approximately 7 months)	0.00% 0/15 • On or after first day of study intervention through to follow-up visit (approximately 7 months)	0.00% 0/8 • On or after first day of study intervention through to follow-up visit (approximately 7 months)

Other adverse events

Additional Information

Study Director

Lykos Therapeutics

Phone: 877-627-7722

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place