Psilocybin rTMS for Treatment Resistant Depression

This Phase II clinical trial, sponsored by the University of Texas at Austin, aims to assess the safety, feasibility, and efficacy of combining psilocybin (25mg) therapy with accelerated intermittent theta burst (aiTBS) repetitive transcranial magnetic stimulation (rTMS) in individuals with treatment-resistant major depressive disorder (TRD).

The study will involve 100 participants aged 22-65 with treatment-resistant MDD who will be randomly assigned to receive either 25mg of COMP360 (psilocybin) or a low-dose comparator along with active or sham aiTBS rTMS treatment. This will be followed by a series of sessions over two weeks involving psilocybin therapy, integration sessions, and neurobiological assessments, along with 10 sessions of active or sham aiTBS rTMS.

The primary aim is to determine the safety, feasibility, and efficacy of this treatment approach in individuals with treatment-resistant MDD. Additionally, the study aims to evaluate neurobiological changes following the combination treatment and investigate how psychedelic treatment may impact blood biomarkers of inflammation and functional genetic polymorphisms.

The study will assess various outcome measures including the Montgomery Asberg Depression Rating Scale (MADRS), fMRI task-evoked brain activation, EEG functional connectivity change, and other secondary measures related to depression, anxiety, quality of life, and psychological factors.

Recruitment for the study is not yet underway, with an estimated study start date of January 2024 and estimated completion in May 2027.

Topic Treatment-Resistant Depression Depression
Compound Psilocybin
Country United States of America
Visit trial
Status Not yet recruiting
Results Published No
Start date 01 January 2024
End date 15 May 2027
Phase Phase II
Design Open
Type Interventional
Generation Second
Participants 100
Sex All
Age 22- 65
Therapy Yes

Trial Details

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.

Trial Number NCT06132178

Sponsors & Collaborators

University of Texas at Austin
The Centre for Psychedelic Research and Therapy at UTA will explore the use of psycedelics for treating a number of mental disorders. The research team are focusing on PTSD in veterans and those who've experienced early childhood trauma.

Data attribution

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