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Behavioural Intervention

Psilocybin + rTMS for Depression (PSILOBSD Trial)

Phase 2

Waitlist Available

Led By Gregory A Fonzo, Ph.D.

Research Sponsored by University of Texas at Austin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults, ages 22-65

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)

Must not have

Use of electroconvulsive therapy, deep brain stimulation, or vagus nerve stimulation during the current major depressive episode

Uncontrolled hypertension (resting blood pressure > 140/90 mm hg)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Summary

This trial is exploring if psilocybin therapy combined with a short brain stimulation technique can help people with treatment-resistant depression.

Who is the study for?

Adults aged 22-65 with treatment-resistant major depressive disorder, who have had at least two unsuccessful treatments for their current episode. Participants must be off certain medications before and during the trial, able to attend daily visits for about two weeks, and not have a history of psychotic disorders, substance abuse within the last year, or significant suicide risk recently.

What is being tested?

The study is testing if combining psilocybin therapy with an accelerated form of brain stimulation (aiTBS) is safe and works for people whose depression hasn't improved with other treatments. Some will get real aiTBS plus psilocybin while others will receive sham aiTBS (a fake version) with low-dose psilocybin.

What are the potential side effects?

Possible side effects include headache, nausea, emotional discomfort related to revisiting past experiences during the psychedelic experience. The brain stimulation could cause scalp discomfort or a mild headache.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 22 and 65 years old.

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I have been diagnosed with a major depressive episode lasting at least 3 months.

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I have depression that hasn't improved after trying at least two different antidepressants.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have used treatments like ECT, DBS, or VNS for my current depression episode.

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My blood pressure is not higher than 140/90 mm Hg.

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I have not had serious heart conditions or abnormal heart tests recently.

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I have used psychedelics like LSD or psilocybin in the past year or more than 5 times in my life.

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I've had a severe head injury or was unconscious for over 30 minutes due to a head injury.

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My depression is caused by medication or another health condition.

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I have a neurological disorder or history of brain surgery.

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I have previously undergone rTMS treatment.

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I have a history of seizures or epilepsy.

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I have never been diagnosed with a psychotic, bipolar, or personality disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

EEG functional connectivity change

Montgomery Asberg Depression Rating Scale (MADRS)

fMRI resting state

+1 more

Secondary study objectives

Acceptance and Action Questionnaire II (AAQ II)

Anger Attacks Questionnaire (AAQ)

Anxiety Sensitivity Index 3 (ASI-3)

+18 more

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Full dose COMP360 with active aiTBS rTMSExperimental Treatment2 Interventions

25mg of COMP360 with the active accelerated intermittent theta burst (aiTBS) rTMS treatment known as Stanford Neuromodulation Therapy (SNT) and/or Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT) delivered over 10 sessions daily for 5 consecutive days.

Group II: Full dose COMP360 with sham aiTBS rTMSActive Control2 Interventions

25mg of COMP360 with sham iTBS delivered over 10 sessions daily for 5 consecutive days.

Group III: Low dose comparator with active aiTBS rTMSActive Control2 Interventions

1mg of COMP360 with the active accelerated intermittent theta burst (aiTBS) rTMS treatment known as Stanford Neuromodulation Therapy (SNT) and/or Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT) delivered over 10 sessions daily for 5 consecutive days.

Group IV: Low dose comparator with sham aiTBS rTMSPlacebo Group2 Interventions

1mg of COMP360 with with sham iTBS delivered over 10 sessions daily for 5 consecutive days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Psilocybin

2021

Completed Phase 2

~750

0 / 13Eligibility criteria met