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Psychedelic

Psilocybin for Depression

Phase 2

Waitlist Available

Led By Scott Aaronson, MD

Research Sponsored by Sheppard Pratt Health System

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline (day -1) to three weeks post-dose.

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether psilocybin can help people with severe treatment-resistant depression.

Who is the study for?

This trial is specifically for veterans who have been diagnosed with moderate to severe Major Depressive Disorder (MDD) and haven't found relief from standard treatments. It's not suitable for individuals with other significant health conditions.

What is being tested?

The study is testing the effects of a single dose of psilocybin (25 mg), given in a supportive setting, on improving symptoms in participants with treatment-resistant depression.

What are the potential side effects?

Psilocybin can cause headache, nausea, dizziness, and psychological effects like changes in perception, mood swings, and hallucinations. These side effects are generally temporary.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline (day -1) to three weeks post-dose.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline (day -1) to three weeks post-dose.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (day -1) to three weeks post-dose. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Montgomery Asberg Depression Rating Scale (MADRS)

Side effects data

From 2021 Phase 2 trial • 95 Patients • NCT02061293

Nausea

Pain

Viral upper resp. tract infection

Back pain

Bronchitis

Diarrhea

Influenza

Headache

Sinus headache

Depressed mood

Depression

Insomnia

Suicidal Ideation

Lower resp. tract congestion

Oropharyngeal pain

Alcohol withdrawal syndrome

Migraine

Thrombocytosis

Constipation

Vomiting

Oedema

Peripheral swelling

Pyrexia

Dermatitis contact

Bronchitis bacterial

Eye infection

Fungal infection

Traumatic lung injury

Hyponatremia

Arthralgia

Musculoskeletal pain

Pain in extremity

Malignant melanoma

Dizziness

Hypoesthesia

Sedation

Anger

Anxiety

Restlessness

Cough

Rhinorrhea

Sinus congestion

Sexual abuse

Endodontic procedure

Mallory-Weiss Syndrom

Anemia

Influenza like Illness

Gingivitis

Arthoscopic surgery

100%

80%

60%

40%

20%

Study treatment Arm

Diphenhydramine

Psilocybin

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: PsilocybinExperimental Treatment1 Intervention

25mg of Psilocybin Note: CA site only is re-dosing participants with an exacerbation in depressive symptoms at a minimum of 12 months post-initial dosing.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Psilocybin

2021

Completed Phase 2

~530

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