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Sustaining Remission From PTSD Using Tuned Vibroacoustic Stimulation (TVS) Following MDMA-Assisted Psychotherapy

NCT05274230 · Apollo Neuroscience, Inc.

Closed to entry
Status
Not accepting participants
Not applicable
Phase
200
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

The purpose of this research is to examine a wearable device called Apollo that emits gentle vibrations found to benefit mood, energy, and focus. We want to understand how it affects outcomes related to MDMA-assisted psychotherapy for PTSD including depression, anxiety and emotion regulation. This study will test whether regular use of the Apollo wearable improves rates of sustained symptom remission in PTSD following MDMA-assisted psychotherapy over the course of two years

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • PTSD Checklist for DSM-5 (PCL-5)

    Measured over Through study completion, an average of two years

  • Beck Depression Inventory II (BDI-II)

    Measured over Through study completion, an average of two years

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years
Ages
All
Sex
Accepted
Healthy volunteers
Inclusion Criteria: * Age 18 or over * Completion of the MAPS MDMA-Assisted Psychotherapy for PTSD clinical trial (treatment cohort) * completion of the MAPS MDMA-Assisted Psychotherapy for PTSD clinical trial (placebo cohort) * enrolled in the MAPS MDMA-Assisted Psychotherapy for PTSD clinical trial, but dropped out Exclusion Criteria: * Unable to give adequate informed consent * Have any current problem which, in the opinion of the investigator might interfere with participation * Are unable to complete questionnaires written in English

Where

1 study site

FacilityCityRegionCountry
Apollo Neuroscience, Inc.PittsburghPennsylvaniaUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT05274230 on ClinicalTrials.gov →

Last updated in the registry 2023-02-02. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Recruiting in