What side effects are associated with this type of intervention?

Common treatments for suicidal thoughts include SSRIs (Selective Serotonin Reuptake Inhibitors) and other serotonergic agents. SSRIs, such as fluoxetine and sertraline, can cause side effects like nausea, insomnia, dizziness, weight gain, and sexual dysfunction. Psilocybin, a serotonin receptor agonist, is being studied for its potential benefits in treatment-resistant depression and suicidal ideation. Known side effects of psilocybin include transient anxiety, confusion, nausea, and increased blood pressure. It is important to discuss these options and their side effects with a healthcare provider to determine the most appropriate treatment.

What prior FDA approvals exist?

Currently, there are no FDA-approved treatments specifically for suicidal thoughts that are serotonin receptor agonists like psilocybin. However, some antidepressants, such as SSRIs (e.g., fluoxetine, sertraline), which also act on serotonin receptors, are used to manage depression and associated suicidal ideation. Esketamine, a nasal spray approved by the FDA, is used for treatment-resistant depression and has shown efficacy in reducing suicidal thoughts. Psilocybin is still under investigation for its potential benefits in treating depression and suicidal ideation.

What other types of research exist?

Promising novel alternatives to psilocybin for treating suicidal thoughts include: 1) Esketamine (intranasal) - shown to rapidly reduce symptoms of depression and suicidality. 2) Lithium augmentation - effective in treatment-resistant depression and reducing suicidal ideation. 3) Ketamine (IV) - provides rapid relief of depressive symptoms and suicidal thoughts. 4) Electroconvulsive Therapy (ECT) - effective for severe depression and acute suicidality. 5) Transcranial Magnetic Stimulation (TMS) - non-invasive and effective for treatment-resistant depression.

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Psychedelic

Psilocybin for Depression

Phase 2

Recruiting

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 baseline (v2) to day 1 (v4), week 1 (v5), week 2 (v6), week 3 (v7), week 6 (v8), week 9 (v9) and week 12 (v10)

Awards & highlights

No Placebo-Only Group

Summary

This trial explores the safety of a single 25mg dose of psilocybin given to adults with depression that hasn't improved with other treatments and who have ongoing suicidal thoughts. Psilocybin works by changing brain cell communication to improve mood and reduce negative thoughts. Psilocybin has shown promise in treating depression, anxiety, and other mental health conditions in recent studies.

Who is the study for?

This trial is for adults aged 18-65 with Major Depressive Disorder who haven't improved after trying at least two medications and have ongoing suicidal thoughts but no immediate intent to harm themselves. It's not open to those with schizophrenia, bipolar disorder, borderline personality disorder, or current substance abuse issues.

What is being tested?

The study tests the safety and effects of a single dose of Psilocybin (25mg) given in a supportive setting to see if it can help people with treatment-resistant depression and chronic thoughts of suicide.

What are the potential side effects?

Possible side effects may include temporary changes in perception, mood swings, dizziness, nausea, headache or fatigue. Long-term psychological effects are also possible but will be closely monitored.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (v2) to day 1 (v4), week 1 (v5), week 2 (v6), week 3 (v7), week 6 (v8), week 9 (v9) and week 12 (v10)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (v2) to day 1 (v4), week 1 (v5), week 2 (v6), week 3 (v7), week 6 (v8), week 9 (v9) and week 12 (v10)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (v2) to day 1 (v4), week 1 (v5), week 2 (v6), week 3 (v7), week 6 (v8), week 9 (v9) and week 12 (v10) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Columbia-Suicide Severity Rating Scale (C-SSRS)

Secondary study objectives

Clinical Global Impression - Modified for Depression (CGI-D)

Feeling suicidal (finding)

Concise Health Risk Tracking Self Report 12 Items (CHRT-SR)

+1 more

Other study objectives

Modified Scale for Suicidal Ideation (MSSI)

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 suicidal thoughts often target the brain's serotonin system. Psilocybin, a serotonin receptor agonist, acts on 5-HT2A receptors, potentially 'resetting' dysfunctional neural circuits associated with depression and suicidal ideation. SSRIs, another common treatment, increase serotonin levels by inhibiting its reuptake, thereby improving mood and reducing suicidal thoughts. Cognitive-behavioral therapy (CBT) helps patients reframe negative thought patterns, addressing the cognitive aspects of suicidal ideation. Understanding these mechanisms is crucial as they highlight the importance of targeting specific neurochemical pathways and cognitive processes to alleviate symptoms and improve mental health.

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.