RecruitingTreatment Resistant DepressionMDDMajor Depressive Disorder
Psilocybin rTMS for Treatment Resistant Depression
Eligible age
22–65 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: University of Texas at Austin
You may qualify if…
- ✓ 1. Adults, ages 22-65.
- ✓ 2. English language comprehension suitable to understand experimenter instructions and to communicate to study personnel/staff reasonably easily.
- ✓ 3. 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).
- ✓ 4. Montgomery Asberg Depression Rating Scale (MADRS) score of 20 or greater at baseline assessment (at least moderate severity).
- ✓ 5. 1\. Treatment-resistant MDD, defined as either: a) failure to respond to an adequate dose and duration of two or more pharmacological treatments, with at least one failed medication trial occurring in the current major depressive episode; or b) failure to respond to an adequate dose and duration of 2 or more pharmacological treatments of different pharmacological classes in one or more past major depressive episodes. Adequate treatment dose and duration will be determined through the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH-ATRQ). Augmentation, where an add-on medication is used, will be counted as a second treatment, provided it is approved as an adjunctive treatment of MDD in the country where prescribed.
- ✓ 6. Willingness and ability to attend daily, full-day visits to the research site for a period of \~2 weeks and to participate in all study procedures (clinical assessments, treatments, and neurobiological assessments).
- ✓ 7. If currently taking an antidepressant medication (an SSRI, SNRI, or atypical antidepressant), antipsychotic, and/or other augmenting medication (e.g., lithium), willingness to discontinue medication(s) over a 2-8 week period with the assistance of study staff and maintain at least a 2-5 week period (5-week period for fluoxetine) off of medications prior to the baseline visit AND willingness to remain off medications for a period of 1 month following the end of the treatment course (approximately 6-8 weeks after the baseline visit).
You may not qualify if…
- ✕ 1. 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).
- ✕ 2. Current diagnosis of posttraumatic stress disorder, acute stress disorder, obsessive-compulsive disorder, anorexia nervosa, bulimia nervosa, or alcohol or substance-use disorder.
- ✕ 3. Having met criteria for an alcohol or substance-use disorder within the past year.
- ✕ 4. Use of electroconvulsive therapy, deep brain stimulation, or vagus nerve stimulation during the current major depressive episode.
- ✕ 5. Any prior rTMS treatment (10Hz, 5Hz, 1Hz, or conventional intermittent theta burst).
- ✕ 6. Current participation in an evidence-based psychotherapy for major depression (e.g., cognitive behavioral therapy, behavioral activation). Ongoing supportive psychotherapy is allowable if maintained at the same frequency throughout the duration of the short-term follow-up clinical endpoint (1 month after treatment cessation) of the study and if no recent change in therapy type or frequency for 1 month prior to enrollment.
- ✕ 7. Exhibiting significant suicide risk within the past 12 months, at screening, or at baseline, as evidenced by: a) suicidal ideation with some intent to act but no specific plan (item #4 from the Columbia Suicide Severity Rating Scale57; C-SSRS); b) suicidal ideation with intent to act and a specific plan (item #5 from the C-SSRS); c) suicide attempt or non-suicidal self-injury requiring medical attention in the past 12 months; or d) self-report of significant suicidal ideation with intent or significant non-suicidal self-injury during screening or baseline clinical interview.
- ✕ 8. Major depressive episode that is secondary to a medication or a general medical condition, as judged by investigators.
Where it's recruiting
Texas
Austin
Source: ClinicalTrials.gov · NCT06132178 · last updated 2025-11-26