Trial · NCT06989957
Psilocybin and Methylenedioxymethamphetamine (MDMA) for Post-traumatic Stress Disorder (PTSD)
NCT06989957, Phase 1, Recruiting, Johns Hopkins University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Psilocybin and Methylenedioxymethamphetamine (MDMA) for Post-traumatic Stress Disorder (PTSD). Trials, record NCT06989957. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06989957
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Psilocybin and Methylenedioxymethamphetamine (MDMA) for Post-traumatic Stress Disorder (PTSD)
- NCT number
- NCT06989957
- Status
- Recruiting
- Phases
- Phase 1
- Enrollment
- 40 participants, estimated
- Lead sponsor
- Johns Hopkins University
- Conditions
- Posttraumatic Stress Disorder
- Interventions
- Psilocybin, Psilocybin, MDMA, MDMA
- First posted
- 2025-05-25
- Last updated
- 2026-09-04
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Adverse Events | 30 weeks | Participants will be asked how the participant has been feeling since the last visit and will be asked about incidence of any adverse events (AEs) since the last visit. In addition to monitoring any spontaneously reported AEs at each study visit, participants will also be queried specifically if the participant has experienced any return of drug-like (i.e., MDMA or psilocybin) effects or other AEs the participant suspects to be drug-related at all meetings occurring after the first dosing session. A serious adverse event (SAE) will be defined as either: a death or a life-threatening occurrence, including hospitalization; incarceration; new onset of a significant medical disorder; or significant exacerbation of an existing medical disorder. All AEs and SAEs will be monitored closely by the study team to guide appropriate follow-up and all AEs and SAEs will be documented and followed to resolution. |
| Primary | The Columbia Suicide Severity Rating Scale (C-SSRS) | 33 weeks | The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess severity of suicide ideation during every study visit. Suicidal Ideation Intensity scale (0-25 score range summed from five items, with higher scores indicating more severe suicidal ideation). |
| Primary | Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual-5 (CAPS-5) | 33 weeks | The CAPS-5 assessment consists of 30 items that are designed to measure the frequency and intensity of PTSD symptoms, covering all 20 Diagnostic and Statistical Manual-5 (DSM-5) PTSD symptoms. Each item is scored on a 5-point scale (0, absent - 4, extreme/incapacitating). Score ranges from 0 to 80 with higher scores indicating higher symptom severity. |
| Primary | PTSD Checklist (PCL-5) | 33 weeks | The PTSD Checklist for DSM-5 is a self-report psychometric instrument widely employed in both clinical and research settings to assess the presence and severity of PTSD symptoms as outlined in the DSM-5. The PCL-5's 20 items correspond to the DSM-5 symptom criteria for PTSD. This version of the PCL-5 will assess symptoms within the preceding week. PCL-5 questionnaires will be administered to participants via email (not clinician-administered). It is scored by summing the responses to 20 items, each rated on a 5-point scale (0-4), resulting in a total score ranging from 0 to 80. A higher score indicates greater severity of PTSD symptoms. |
| Primary | World Health Organization Quality of Life- Brief version (WHOQOL-BREF) | 33 weeks | The World Health Organization Quality of Life (WHOQOL) Brief version scores on this subscales range from 0-30 with higher scores reflecting better quality of life. |
| Secondary | Clinical Global Impression (CGI-I) Scale | 9 weeks | The CGI-I scale ranges from 1 to 7 (1=very much improved; 2=much improved, 3=minimally Improved, 4=no change, 5=minimally worse, 6= much worse, and 7=very much worse). |
| Secondary | Patient global impression of improvement (PGI-I) | 9 weeks | The PGI-I was developed for use in National Institute of Mental Health sponsored clinical trials in order to broadly define participant progress/improvement. The PGI-I scale is a 7-point scale used to assess a patient's perception of condition's change, typically after a treatment or intervention. The scale ranges from 1 to 7, with 1 representing "very much improved" and 7 representing "very much worse." |
| Secondary | The Sheehan Disability (SDS) Scale | 33 weeks | The Sheehan Disability (SDS) Scale will be used to assess functional impairment in three domains of disability that can be impaired during depression: work/school, social, and family life. It uses a Likert scale from 0 to 10, with higher scores indicating greater functional impairment. The total SDS score ranges from 0 to 30. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06989957
GET https://conductscience.org/api/trials/v1/NCT06989957/registered