What side effects are associated with this type of intervention?

Common treatments for depression, such as SSRIs (e.g., fluoxetine, escitalopram) and SNRIs (e.g., duloxetine), often have side effects including nausea, headache, sexual dysfunction, insomnia, and dry mouth. Psilocybin, a serotonin receptor agonist, has been studied for its potential antidepressant effects and may cause transient side effects such as nausea, dizziness, and perceptual changes. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for depression, primarily focusing on selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine, escitalopram, and sertraline. These medications work by increasing serotonin levels in the brain, similar to the mechanism of action of psilocybin, which is a serotonin receptor agonist. Other related drugs include serotonin-norepinephrine reuptake inhibitors (SNRIs) like duloxetine and venlafaxine. These treatments have been shown to be effective in managing depressive symptoms, although their efficacy can vary among individuals.

What other types of research exist?

Promising novel alternatives to Psilocybin for depression treatment include: 1) Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) such as venlafaxine and desvenlafaxine, which have shown efficacy in clinical trials. 2) Selective Serotonin Reuptake Inhibitors (SSRIs) like paroxetine, which is FDA-approved for hot flashes and has demonstrated benefits for depression. 3) Secondary tricyclic antidepressants such as desipramine, which can be considered if other options are poorly tolerated. 4) Bupropion, particularly for patients with co-occurring fatigue or somnolence, though it should be avoided in those at risk for seizures. 5) Glucocorticoids, which may be useful for cancer-related depression but require careful risk-to-benefit analysis. 6) Non-inhaled medical cannabis or cannabinoids like dronabinol or nabilone for refractory pain and associated depressive symptoms.

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Psilocybin for Depression and Alcoholism (PsiloMDDAUD Trial)

Phase 2

Recruiting

Led By Frederick S Barrett, PhD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

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

Must have

Have a confirmed DSM-5 diagnosis of Major Depressive Disorder and currently experiencing a major depressive episode

Have a confirmed DSM-5 diagnosis of Major Depressive Disorder and currently experiencing a major depressive episode.

Must not have

Currently taking medications for the treatment of depression or alcohol use disorder

Have a first or second-degree relative with schizophrenia spectrum or other psychotic disorders (except substance/medication-induced or due to another medical condition)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1 week, 1 month, and 3 month post-drug-session visits; 6 and 12 month follow-ups after the second experimental drug administration session

Summary

This trial is testing if psilocybin can help people with both depression and alcohol problems. The drug might improve mood and reduce drinking by changing brain activity. The study involves giving psilocybin to see if it helps. Psilocybin is a naturally occurring psychedelic that has shown promise in treating mood and substance use disorders.

Who is the study for?

Adults aged 21-65 with both Major Depressive Disorder and Alcohol Use Disorder, not currently on antidepressants or medications for alcohol dependency. Participants must have a history of depression therapy, limited use of hallucinogens, be medically stable, at low risk for suicide, agree to contraception if applicable, and refrain from certain substances before sessions.

What is being tested?

The trial is testing the effectiveness of psilocybin versus a placebo in reducing symptoms of depression and alcohol consumption in patients with co-occurring MDD and AUD. It aims to see if this hallucinogenic drug can help where standard treatments haven't been started or are no longer desired.

What are the potential side effects?

Psilocybin may cause temporary changes in perception, sense of time and space, increased heart rate, nausea, headache, dizziness. Psychological effects include anxiety or distress during the experience (often referred to as a 'bad trip').

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 Depressive Disorder and am currently having a depressive episode.

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I have been diagnosed with Major Depressive Disorder and am currently having a depressive episode.

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I am between 21 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 currently on medication for depression or alcohol use.

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A close family member has schizophrenia or a similar condition.

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I am not pregnant, nursing, or at risk of becoming pregnant due to ineffective contraception.

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I take prescribed mental health medication daily.

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I smoke or use nicotine equivalent to more than 10 cigarettes daily.

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Electroconvulsive therapy didn't improve my current depression.

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I have not had serious heart issues or strokes in the past year.

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I have epilepsy with a history of seizures.

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I use insulin for my diabetes and haven't had low blood sugar with pills.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1 week, 1 month, and 3 month post-drug-session visits; 6 and 12 month follow-ups after the second experimental drug administration session

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1 week, 1 month, and 3 month post-drug-session visits; 6 and 12 month follow-ups after the second experimental drug administration session

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 week, 1 month, and 3 month post-drug-session visits; 6 and 12 month follow-ups after the second experimental drug administration session for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change from baseline in gamma-glutamyl transferase (GGT)

Change from baseline in grid-version of the Hamilton Depression Rating Scale (GRID-HAMD) score

Change from baseline in percentage of days abstinent as measured by the Time Line Follow Back (TLFB) assessment

+2 more

Secondary study objectives

Change from baseline in %CDT

Change from baseline in AST/ALT ratio

Change from baseline in GGT

+4 more

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

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Psilocybin TreatmentExperimental Treatment1 Intervention

Participants will be administered 25mg of psilocybin in a clinical setting. Psilocybin is administered orally as a capsule and taken with water.

Group II: PlaceboPlacebo Group1 Intervention

Participants will be administered placebo in a clinical setting. Placebo is administered orally as a capsule taken with water.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Psilocybin

2021

Completed Phase 2

~530

0 / 12Eligibility 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 SSRIs, SNRIs, tricyclic antidepressants, and psychostimulants. SSRIs (Selective Serotonin Reuptake Inhibitors) work by increasing serotonin levels in the brain by inhibiting its reuptake into neurons, which helps improve mood and emotional stability. SNRIs (Serotonin-Norepinephrine Reuptake Inhibitors) increase both serotonin and norepinephrine levels, providing a broader range of symptom relief. Tricyclic antidepressants also increase serotonin and norepinephrine but have more side effects due to their broader mechanism of action. Psychostimulants like methylphenidate increase dopamine and norepinephrine levels, which can help with energy and focus. Psilocybin, a serotonin receptor agonist, directly stimulates serotonin receptors, potentially offering rapid and sustained antidepressant effects. Understanding these mechanisms is crucial for depression patients as it helps tailor treatments to individual needs, potentially improving efficacy and reducing side effects.

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