Psilocybin rTMS for Treatment Resistant Depression
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age22-65
SponsorUniversity of Texas at Austin
About this trial
The purpose of this study is to determine the safety and feasibility of sequencing psilocybin therapy with a short-duration, aiTBS protocol (Stanford Accelerated Intelligent Neuromodulation Therapy, or SAINT) in individuals with treatment-resistant major depressive disorder.
Eligibility criteria
Qualifiers
Adults, ages 22-65.
English language comprehension suitable to understand experimenter instructions and to communicate to study personnel/staff reasonably easily.
Current major depressive episode (without psychotic features), either as part of recurrent major depressive disorder (MDD) or single episode MDD with current episode present for at least the past 3 months (as determined by the Structured Clinical Interview for DSM-5; SCID-5).
Montgomery Asberg Depression Rating Scale (MADRS) score of 20 or greater at baseline assessment (at least moderate severity).
Disqualifiers
Prior history or current diagnosis of a psychotic disorder (including MDD with psychotic features), bipolar disorder, or personality disorder (based on medical history, clinician judgement, SCID-5 and/or SCID for Personality Disorders).
Current diagnosis of posttraumatic stress disorder, acute stress disorder, obsessive-compulsive disorder, anorexia nervosa, bulimia nervosa, or alcohol or substance-use disorder.
Having met criteria for an alcohol or substance-use disorder within the past year.
Use of electroconvulsive therapy, deep brain stimulation, or vagus nerve stimulation during the current major depressive episode.
Trial design
Treatments tested in this trial
- Psilocybin
- Accelerated intermittent theta burst (aiTBS) rTMS treatment
- Low-dose psilocybin
- Sham Accelerated intermittent theta burst (aiTBS) rTMS treatment
Treatment groups
100 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov