What side effects are associated with this type of intervention?

Common treatments for depression, such as selective serotonin reuptake inhibitors (SSRIs), often have side effects including nausea, headache, sexual dysfunction, insomnia, and weight gain. Psilocybin, a serotonin receptor agonist, has been studied for its potential antidepressant effects and may cause transient side effects such as altered perception, emotional variability, and, in some cases, anxiety or paranoia. Both SSRIs and psilocybin require careful monitoring by healthcare providers to manage these side effects effectively.

What prior FDA approvals exist?

The FDA has approved several classes of drugs for the treatment of depression, including selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine, escitalopram, and sertraline, which increase serotonin levels in the brain. Additionally, serotonin-norepinephrine reuptake inhibitors (SNRIs) like duloxetine and venlafaxine are also approved. While psilocybin, a serotonin receptor agonist, is not yet FDA-approved for depression, it is being studied for its potential benefits in treatment-resistant major depressive disorder. These studies are part of a broader interest in serotonergic psychedelics for mood disorders.

What other types of research exist?

Promising novel alternatives to Psilocybin for depression treatment include: 1) Esketamine, a rapid-acting nasal spray approved for treatment-resistant depression. 2) Brexanolone, specifically for postpartum depression. 3) Serotonin-norepinephrine reuptake inhibitors (SNRIs) like Duloxetine and Venlafaxine. 4) Secondary tricyclic antidepressants such as Desipramine. 5) Bupropion, particularly if depression is accompanied by fatigue or somnolence. These alternatives have shown efficacy in clinical trials and are considered viable options for patients seeking novel treatments in 2024.

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Psychedelic

Psilocybin for Depression

Phase 2

Waitlist Available

Led By Sharmin Ghaznavi, MD, PhD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, the day before psilocybin administration and at 1 day, 1 week, 2 weeks, 3 weeks, 6 weeks, 9 weeks and 12 weeks after psilocybin administration.

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how a single dose of psilocybin affects negative thinking and brain activity in people with depression that doesn't improve with standard treatments. Psilocybin is a classic psychedelic compound that has shown potential in treating mood and substance use disorders.

Who is the study for?

This trial is for adults aged 18-55 with treatment-resistant major depressive disorder (MDD), who have not improved after trying multiple antidepressants. Participants must be right-handed, able to read well, and have stopped all antidepressant medications at least two weeks before the study starts. They should also be under ongoing mental health care.

What is being tested?

The study tests how a single dose of psilocybin affects self-focused thought patterns in people with MDD resistant to standard treatments. It involves brain scans (fMRI) to see changes in brain activity related to these thought processes.

What are the potential side effects?

Psilocybin can cause headaches, nausea, increased heart rate and blood pressure, psychological distress or confusion during the experience ('bad trip'), and potential temporary changes in perception or mood.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, the day before psilocybin administration and at 1 day, 1 week, 2 weeks, 3 weeks, 6 weeks, 9 weeks and 12 weeks after psilocybin administration.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, the day before psilocybin administration and at 1 day, 1 week, 2 weeks, 3 weeks, 6 weeks, 9 weeks and 12 weeks after psilocybin administration.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, the day before psilocybin administration and at 1 day, 1 week, 2 weeks, 3 weeks, 6 weeks, 9 weeks and 12 weeks after psilocybin administration. 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 in Massachusetts General Hospital Rumination Questionnaire (MGH-RQ)

Change in Resting-State Functional Connectivity

Change in Self-Attribution Task performance

+1 more

Secondary study objectives

Change in Behavior Rating Inventory of Executive Function - Adult Version (BRIEF)

Change in Cognitive Flexibility Inventory (CFI)

Change in Depression Implicit Attitudes Task (IAT)

+9 more

Other study objectives

Change in Brief Fear of Negative Evaluation Scale - Second Version (BFNE-II)

Change in Personal Space Task

Change in Self-Consciousness Scale (SCS)

+3 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

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Psilocybin

Not yet FDA approved

Do I qualify?Apply below to find out

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 antidepressants such as SSRIs (Selective Serotonin Reuptake Inhibitors), SNRIs (Serotonin-Norepinephrine Reuptake Inhibitors), and tricyclic antidepressants, which work by increasing the levels of neurotransmitters like serotonin and norepinephrine in the brain. Psilocybin, a serotonin receptor agonist, binds to serotonin receptors, potentially leading to rapid and sustained antidepressant effects. Psychotherapeutic approaches like Cognitive Behavioral Therapy (CBT) and Interpersonal Therapy (IPT) focus on altering negative thought patterns and improving interpersonal relationships. Understanding these mechanisms helps patients and clinicians choose the most appropriate treatment, potentially leading to better outcomes and personalized care.

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