Psilocybin + Cognitive Behavioral Therapy for Depression

Age: 18 - 65
Sex: Any
Trial Phase: Phase 2
Sponsor: University of California, Los Angeles
Must be taking: Anti-hypertensives
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding psilocybin, a compound found in certain mushrooms, to group cognitive-behavioral therapy can help people with major depression. The goal is to determine if this combination effectively reduces depressive symptoms and improves daily life. Participants will take psilocybin in a group setting and attend therapy sessions together. This trial may suit individuals with major depression, active symptoms, and a supportive person to assist with transportation after sessions. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to important early-stage findings.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications. The trial excludes participants currently using antidepressants, other serotonergic substances, lithium, efavirenz, and opioids. However, if you are on anti-hypertensive medications, you must continue taking them.

Is there any evidence suggesting that psilocybin is likely to be safe for humans?

Research has shown that psilocybin can cause some side effects, but many people tolerate it well. In past studies, psilocybin was linked to negative effects like nausea and increased thoughts of suicide, particularly around the time of dosing. One study found a higher incidence of nausea with psilocybin. However, these effects are not permanent and typically occur shortly after taking the drug.

Despite these side effects, studies have demonstrated that psilocybin can effectively treat depression. Most participants in these studies experienced a significant reduction in depression symptoms. Another study found that these benefits could last up to a year for many patients.

While psilocybin shows promise, it is important to consider both the potential side effects and the positive outcomes observed in previous research.12345

Why are researchers excited about this trial's treatment for depression?

Researchers are excited about psilocybin combined with Cognitive Behavioral Therapy (CBT) for treating depression because it offers a novel approach compared to standard antidepressants like SSRIs and SNRIs. Unlike traditional medications that typically work by altering neurotransmitter levels over weeks, psilocybin acts quickly, often showing effects after just a single dose. Additionally, psilocybin has a unique mechanism of action, activating serotonin receptors in a way that may promote new perspectives and emotional breakthroughs during therapy sessions. This combined approach could provide faster relief and potentially more profound, lasting improvements in depressive symptoms.

What evidence suggests that psilocybin might be an effective treatment for depression?

Research has shown that psilocybin can help treat major depressive disorder (MDD). Studies have found that psilocybin significantly reduces symptoms of depression, with effects lasting up to a year for many individuals. In one study, a 25 mg dose of psilocybin led to a significant drop in depression severity. Another review of several studies demonstrated that psilocybin improved depressive symptoms much more than a placebo (a fake treatment). Additionally, psilocybin treatment has been linked to increased empathy and self-acceptance, with few side effects reported. Overall, psilocybin appears to be a promising treatment for depression.

In this trial, participants will receive two administrations of psilocybin, along with 12 sessions of Cognitive Behavioral Therapy (PA-CBT), delivered in a group format.23467

Are You a Good Fit for This Trial?

This trial is for adults aged 21-60 who currently have depression or a history of major depressive episodes, are fluent in English, can swallow capsules, and have someone to drive them home after sessions. Women must use effective birth control. Participants must avoid alcohol and other drugs around treatment times.

Inclusion Criteria

I am between 21 and 60 years old.
* Meets for a current major depressive episode or a history of major depressive episodes based on the DSM-5 criteria (American Psychiatric Association, 2013)
* Active current depressive symptoms (i.e., scores \>16 on the Hamilton-Depression Rating Scale covering the prior 2 weeks; Hamilton, 1986)
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 12 sessions of PA-CBT and two administrations of psilocybin in a group format

4 months
12 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Psilocybin

Trial Overview

The study tests whether adding psilocybin (a psychedelic drug) to group cognitive behavioral therapy (CBT) is practical and acceptable for treating major depression. It also looks at how this combined approach affects mood and daily functioning.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Group PACBTExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials
1,594
Recruited
10,430,000+

Citations

Psilocybin, an Effective Treatment for Major Depressive ... - PMC

It was found that every study significantly favoured the use of psilocybin in reducing depressive symptoms, with few side effects.

Efficacy and Safety of Psilocybin in Treatment-Resistant ...

In this RCT in patients with TRD, psilocybin, 25 mg, with psychotherapy did not increase response rates (primary end point) but produced greater ...

Psilocybin Treatment for Major Depression Effective for Up ...

The researchers reported that psilocybin treatment in both groups produced large decreases in depression, and that depression severity remained ...

Five-year outcomes of psilocybin-assisted therapy for ...

Participants reported enhanced empathy, self-acceptance, and improved interpersonal relationships. No severe adverse events were reported.

Efficacy and safety of psilocybin in the treatment of Major ...

From 5419 search results, three RCTs involving 389 patients were included. Psilocybin significantly reduced symptoms compared to placebo at Day 8 (MD = -7.42; ...

Efficacy and safety of psilocybin-assisted treatment for major ...

These findings demonstrate that the substantial antidepressant effects of psilocybin-assisted therapy may be durable at least through 12 months ...

A Study of Psilocybin for Major Depressive Disorder (MDD)

Data suggest that psilocybin may have behavioral effects relevant to the treatment of depression and recent studies also suggest that psilocybin may possess ...