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
This trial does not accept healthy volunteersQualifiers
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
Design model
Factorial
Treatments tested in this trial
Psilocybin
DrugA psychedelic drug found in certain mushrooms. It will be in a capsule of 25mg psilocybin (COMP360).
Accelerated intermittent theta burst (aiTBS) rTMS treatment
DeviceA form of non-invasive brain stimulation that delivers a series of quick magnetic pulses to the scalp and a portion of the brain. It will be targeted to a functional magnetic resonance imaging (fMRI) functional connectivity-guided personalized left dorsolateral prefrontal cortex target using neuronavigation and delivered over 10 sessions daily for 5 consecutive days at 90% of coil-to-target depth-corrected resting motor threshold.
Low-dose psilocybin
DrugA psychedelic drug found in certain mushrooms. It will be in a low-dose form of the experimental dose as a 1mg capsule of psilocybin (COMP360).
Sham Accelerated intermittent theta burst (aiTBS) rTMS treatment
DeviceThe sham version is meant to look and feel like the active SAINT rTMS, but the main difference is that the brain is not being stimulated like the active condition.
Treatment groups
100 Participants
are divided into 4 treatment groupsGroup A: Full dose COMP360 with active aiTBS rTMSExperimental treatment 2 interventions
Group B: Full dose COMP360 with sham aiTBS rTMSActive comparator 2 interventions
Group C: Low dose comparator with active aiTBS rTMSActive comparator 2 interventions
Group D: Low dose comparator with sham aiTBS rTMSSham comparator 2 interventions
Trial outcomes
Primary outcomes
1
Montgomery Asberg Depression Rating Scale (MADRS)
A ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Scoring ranging from 0 to 60, with higher scores indicating greater depressive symptomology.
Time frame
12 months2
fMRI task-evoked brain activation
A method used in functional magnetic resonance imaging (fMRI) to observe different areas of the brain or other organs, which are found to be active at any given time.
Time frame
At both 1 week and 2 weeks3
fMRI resting state
A method aimed at examining intrinsic networks in the brain while no task is performed (rest) in order to estimate correlations between brain regions.
Time frame
At both 1 week and 2 weeks4
EEG functional connectivity change
A method aimed at examining intrinsic networks in the brain to estimate correlations between brain regions.
Time frame
At both 1 week and 2 weeksSecondary outcomes
1
Snaith Hamilton Pleasure Scale (SHAPS)
A self-report measure of anhedonia. Scoring range from 0 to 14, with lower scores indicating less anhedonia.
Time frame
12 months2
Quick Inventory of Depressive Symptom Self-Report (QIDS-SR)
A self report measure of depressive symptoms. Scores range from 0 to 48, with lower scores indicating less symptoms of depression.
Time frame
12 months3
World Health Organization Quality of Life Inventory-Brief subscale (WHO-QL-Brief)
A self-report measure of quality of life with four subscales: Physical Health, Psychological Health, Social Relationships, and Environment. Scores for each range from 4-20, with higher scores indicating better quality of life.
Time frame
12 months4
Beck Depression Inventory II (BDI II)
A self-report measure of positive and negative affect. There are scores for Positive Affect and Negative Affect, each of which is scored from 10-50. Higher scores indicate more of that particular type of affect.
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov