What side effects are associated with this type of intervention?

Common treatments for depression, such as SSRIs, TCAs, and SNRIs, have a range of side effects. SSRIs, including fluoxetine and sertraline, often cause nausea, insomnia, sexual dysfunction, and weight gain. TCAs like amitriptyline and nortriptyline can lead to dry mouth, constipation, urinary retention, and sedation. SNRIs, such as venlafaxine and duloxetine, may result in increased blood pressure, dizziness, and sweating. Psilocybin, a serotonergic psychedelic, can cause transient anxiety, confusion, nausea, and perceptual changes.

What prior FDA approvals exist?

The FDA has approved several treatments for depression that act on the serotonin system, similar to psilocybin. Selective serotonin reuptake inhibitors (SSRIs) like escitalopram and fluoxetine are commonly prescribed and have shown efficacy in numerous clinical trials. Additionally, serotonin-norepinephrine reuptake inhibitors (SNRIs) such as duloxetine have also been approved for depression treatment. These medications work by increasing serotonin levels in the brain, which helps alleviate depressive symptoms. While psilocybin is still under investigation, its mechanism as a serotonin receptor agonist suggests potential similarities in therapeutic effects with these established treatments.

What other types of research exist?

Promising novel alternatives to Psilocybin for depression treatment in 2024 include: 1) Ayahuasca, which has shown efficacy in treatment-resistant depression; 2) Esketamine, a rapid-acting antidepressant approved for treatment-resistant depression; 3) Serotonin-norepinephrine reuptake inhibitors (SNRIs) like Duloxetine and Venlafaxine; 4) Bupropion, particularly for patients with fatigue or somnolence; 5) Secondary tricyclic antidepressants like Desipramine. Additionally, combining SSRIs or SNRIs with psychotherapy may offer enhanced benefits for some patients.

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Psychedelic

Psilocybin for Depression and Personality Disorders

Phase 2

Recruiting

Led By Jon E Grant, MD, JD, MPH

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

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

Must have

Diagnosed with current major depressive disorder

Age 18-65

Must not have

Current pregnancy or lactation, or inadequate contraception in women of childbearing potential

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 2 to week 5

Awards & highlights

No Placebo-Only Group

Summary

This trial tests psilocybin, a compound from certain mushrooms, on adults with major depressive disorder and borderline personality disorder. It aims to see if psilocybin can improve mood and reduce symptoms by affecting brain chemicals. Psilocybin has shown promise as a treatment for major depressive disorder and has been designated as a breakthrough therapy by the FDA.

Who is the study for?

This trial is for adults aged 18-65 with both major depressive disorder and borderline personality disorder, as indicated by specific scores on the MADRS and ZAN-BPD scales. Participants must understand and sign a consent form. Those with bipolar I, schizophrenia, active substance use disorders (except cannabis), or unstable medical conditions cannot join.

What is being tested?

The study aims to test the safety and effectiveness of psilocybin—a psychedelic compound—in treating individuals who have both major depressive disorder (MDD) and borderline personality disorder (BPD).

What are the potential side effects?

While not explicitly listed in the provided information, common side effects of psilocybin may include nausea, headache, increased heart rate, changes in sensory perception, mood alteration, anxiety or panic reactions.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with major depression.

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I am between 18 and 65 years old.

Exclusion Criteria

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

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I am not pregnant, breastfeeding, and I use effective birth control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 2 to week 5

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 2 to week 5

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 2 to week 5 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Borderline Personality Disorder Symptom Assessment Scale (BPD-SAS)

Montgomery-Asberg Depression Rating Scale (MADRS)

Secondary study objectives

Clinical Global Impression - Improvement scale (CGI-I)

Clinical Global Impression - Severity scale (CGI-S)

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: Experimental: PsilocybinExperimental Treatment1 Intervention

Single 25 mg capsule oral dose of psilocybin

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Psilocybin

Not yet FDA approved

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for depression include pharmacotherapy and psychotherapy. Pharmacological treatments often involve selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), which increase the levels of serotonin and norepinephrine in the brain by inhibiting their reuptake into neurons. Psilocybin, a serotonin receptor agonist, works by directly stimulating serotonin receptors, potentially leading to rapid and sustained antidepressant effects. Psychotherapeutic approaches like cognitive-behavioral therapy (CBT) and mindfulness-based cognitive therapy (MBCT) help patients reframe negative thought patterns and develop coping strategies. Understanding these mechanisms is crucial for patients as it informs them about how these treatments can alleviate symptoms, improve mood, and enhance overall quality of life.

Psilocybin as a New Approach to Treat Depression and Anxiety in the Context of Life-Threatening Diseases-A Systematic Review and Meta-Analysis of Clinical Trials.Psilocybin with psychological support for treatment-resistant depression: an open-label feasibility study.Bulimia nervosa : a review of therapy research.