NCT06132178 Psilocybin rTMS for Treatment Resistant Depression
| NCT ID | NCT06132178 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Texas at Austin |
| Condition | Treatment Resistant Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-01-10 |
| Primary Completion | 2029-12-31 |
Trial Parameters
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Brief Summary
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
Inclusion Criteria: 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
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