What side effects are associated with this type of intervention?

Common treatments for anxiety, particularly serotonergic medications like SSRIs, can cause side effects such as nausea, headache, sleep disturbances, sexual dysfunction, and initial increased anxiety. Psilocybin, a serotonin receptor agonist under study, has shown side effects including transient anxiety, nausea, and perceptual changes during the acute phase of treatment. Both require careful monitoring for adverse effects.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of anxiety, primarily focusing on selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs). These include paroxetine, sertraline, citalopram, escitalopram, venlafaxine, and duloxetine. These drugs increase serotonin and/or norepinephrine levels in the brain to help improve mood and reduce anxiety. Benzodiazepines like lorazepam and alprazolam are also approved for short-term use but are less favored due to their potential for dependence.

What other types of research exist?

Promising novel alternatives to psilocybin for anxiety treatment include kava extracts (such as WS1490), which have shown effectiveness in treating non-psychotic anxiety disorders. Additionally, traditional pharmacotherapies like SSRIs (e.g., escitalopram) and SNRIs (e.g., venlafaxine) remain viable options. For patients with generalized anxiety disorder, hydroxyzine has also been noted for its efficacy. These alternatives provide a range of options for patients seeking treatment for anxiety in 2024.

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Psychedelic

Psilocybin therapy for Anxiety (PDP1 Trial)

Phase 2

Waitlist Available

Research Sponsored by Joshua Woolley, MD, PhD

Eligibility Criteria Checklist

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

Must have

Age 40 to 75

Be older than 18 years old

Must not have

Significant cognitive impairment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 3 months following last drug dose

Awards & highlights

Summary

This trial tests if psilocybin, a substance from mushrooms, can safely help people with early-stage Parkinson's Disease who have depression or anxiety. It works by changing how the brain processes emotions. Psilocybin has been studied for its potential to reduce anxiety and depression in patients with serious illnesses, showing significant decreases in symptoms.

Who is the study for?

This trial is for English-speaking adults aged 40-75 with early-stage Parkinson's Disease (stages 1-3) who are experiencing depression or anxiety. Participants must be able to attend visits at UCSF, have a support person, and an established healthcare provider. Those with severe health conditions, cognitive impairments, psychotic symptoms, or on certain medications like dopamine agonists and MAO inhibitors cannot join.

What is being tested?

The study is examining the safety and effectiveness of psilocybin therapy as a treatment for depression and anxiety in individuals with Parkinson's disease. It aims to understand if this therapy can be tolerated well by patients and how feasible it is as a treatment option.

What are the potential side effects?

While not explicitly listed here, potential side effects may include temporary changes in perception, mood swings, dizziness, nausea or headaches during the immediate period following psilocybin administration.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 40 and 75 years old.

Exclusion Criteria

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

Select...

I have significant difficulties with my memory or thinking.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 3 months following last drug dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 3 months following last drug dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 3 months following last drug 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

Caregiver/support person-reported distress

Cognitive Safety

Parkinson's Disease (PD) symptom severity

+7 more

Secondary study objectives

Effects of psilocybin therapy on self-reported Cognitive Function (exploratory)

Effects of psilocybin therapy on self-reported Concern with Death and Dying (exploratory)

Fatigue

+6 more

Other study objectives

Cognitive Flexibility

Effects of psilocybin therapy on anxiety in people with PD (exploratory)

Effects of psilocybin therapy on depression in people with PD (exploratory)

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Psilocybin therapyExperimental Treatment1 Intervention

Participants will receive one or two doses of psilocybin in a monitored setting approximately two weeks apart, with preparation sessions before and integration sessions after.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Psilocybin

Not yet FDA approved

0 / 2Eligibility 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 anxiety include selective serotonin reuptake inhibitors (SSRIs), benzodiazepines, and serotonin receptor agonists like psilocybin. SSRIs, such as sertraline, work by increasing the levels of serotonin in the brain by inhibiting its reuptake into neurons, which helps improve mood and reduce anxiety. Benzodiazepines, like diazepam, enhance the effect of the neurotransmitter GABA, producing a calming effect. Psilocybin, a serotonin receptor agonist, directly stimulates serotonin receptors, particularly the 5-HT2A receptor, which can lead to altered perception and mood improvements. Understanding these mechanisms is crucial for anxiety patients as it helps in selecting the most appropriate treatment based on how these medications modulate brain chemistry to alleviate anxiety symptoms.

Treatments for Anxiety Disorders in Malaysia.