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Psilocybin for Depression
Phase 1
Waitlist Available
Led By Deepak D'Souza, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosed with Major Depressive Disorder (MDD), single or recurrent episode, and currently experiencing a Major Depressive Episode (MDE)
Failed to achieve a satisfactory clinical response to at least one adequate antidepressant trial during the current depressive episode
Must not have
Axis I psychotic disorder in first degree relative
Currently taking a conventional antidepressant medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up four weeks before the initiation of testing, the day before and after each experimental session, and one and two weeks after each experimental session.
Summary
This trial tests if psilocybin, a compound from mushrooms, can help people with major depression by making their brains more adaptable and improving their symptoms. Psilocybin has shown promise as a treatment for depression in various studies, indicating its potential to improve depressive symptoms.
Who is the study for?
This trial is for adults with Major Depressive Disorder who haven't improved after trying at least one antidepressant. Participants must be currently seeing a mental health professional and not have any psychotic disorders, drug abuse issues, or unstable medical conditions. Pregnant or breastfeeding individuals are excluded, as well as those without proper birth control.
What is being tested?
The study tests if psilocybin can cause changes in the brain that improve depression symptoms. It compares the effects of two different doses of psilocybin to a placebo (a substance with no active drug).
What are the potential side effects?
Psilocybin may cause temporary changes in perception, mood swings, dizziness, nausea, and headaches. Some people might experience intense emotional experiences or anxiety during its use.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Major Depressive Disorder and am currently experiencing a depressive episode.
Select...
My current depression treatment hasn't worked.
Select...
I am currently seeing a mental health professional.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
A close family member has a severe mental health condition.
Select...
I am currently on antidepressant medication.
Select...
I do not have any unstable health or brain conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ four weeks before the initiation of testing, the day before and after each experimental session, one and two weeks after each experimental session, then monthly for three months after the last experimental session.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~four weeks before the initiation of testing, the day before and after each experimental session, one and two weeks after each experimental session, then monthly for three months after the last experimental session.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Changes in electrical brain activity associated with neuroplasticity measured by Electroencephalography (EEG)
Secondary study objectives
Change in mood symptoms using the GRID-Hamilton Depression Rating Scale (GRID-HAM-D)
Change in mood symptoms using the Quick Inventory of Depressive Symptoms (QIDS-SR16)
Changes in verbal memory [ Time Frame: One day and two weeks after each experimental session ]
Trial Design
4Treatment groups
Experimental Treatment
Group I: Placebo/Medium Dose PsilocybinExperimental Treatment2 Interventions
Subjects in this arm receive placebo in the first session and medium dose psilocybin in the second session.
Group II: Placebo/Low Dose PsilocybinExperimental Treatment2 Interventions
Subjects in this arm receive placebo in the first session and low dose psilocybin in the second session.
Group III: Medium Dose Psilocybin/PlaceboExperimental Treatment2 Interventions
Subjects in this arm receive medium dose psilocybin in the first session and placebo in the second session.
Group IV: Low Dose Psilocybin/PlaceboExperimental Treatment2 Interventions
Subjects in this arm receive low dose psilocybin in the first session and placebo in the second session.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Low Dose Psilocybin
2017
Completed Phase 1
~20
Placebo
1995
Completed Phase 3
~2670
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, such as SSRIs (Selective Serotonin Reuptake Inhibitors) and newer therapies like psilocybin, primarily work by altering brain chemistry and promoting neuroplasticity. SSRIs increase serotonin levels in the brain, which can improve mood and emotional stability.
Psilocybin, a psychedelic compound, is believed to induce neuroplasticity, which is the brain's ability to reorganize itself by forming new neural connections. This can lead to significant improvements in depressive symptoms by enhancing cognitive flexibility and emotional processing.
Understanding these mechanisms is crucial for depression patients as it highlights the potential for these treatments to not only alleviate symptoms but also promote long-term brain health and resilience.
Brain-derived neurotrophic factor (BDNF) and neurotrophin 3 (NT3) levels in post-mortem brain tissue from patients with depression compared to healthy individuals - a proof of concept study.Ketamine: promising path or false prophecy in the development of novel therapeutics for mood disorders?
Brain-derived neurotrophic factor (BDNF) and neurotrophin 3 (NT3) levels in post-mortem brain tissue from patients with depression compared to healthy individuals - a proof of concept study.Ketamine: promising path or false prophecy in the development of novel therapeutics for mood disorders?
Find a Location
Who is running the clinical trial?
Yale UniversityLead Sponsor
1,912 Previous Clinical Trials
3,039,454 Total Patients Enrolled
65 Trials studying Depression
20,818 Patients Enrolled for Depression
Heffter Research InstituteOTHER
13 Previous Clinical Trials
481 Total Patients Enrolled
3 Trials studying Depression
110 Patients Enrolled for Depression
Deepak D'Souza, MDPrincipal InvestigatorYale University
3 Previous Clinical Trials
427 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with Major Depressive Disorder and am currently experiencing a depressive episode.A close family member has a severe mental health condition.You have had bad reactions in the past to drugs like psilocybin, LSD, salvinorin A, or mescaline that can change your thinking and perception.My current depression treatment hasn't worked.I am currently seeing a mental health professional.You have a significant problem with your memory or thinking abilities.I am currently on antidepressant medication.I do not have any unstable health or brain conditions.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo/Low Dose Psilocybin
- Group 2: Placebo/Medium Dose Psilocybin
- Group 3: Low Dose Psilocybin/Placebo
- Group 4: Medium Dose Psilocybin/Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Depression Patient Testimony for trial: Trial Name: NCT03554174 — Phase 1
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