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Compares treatment options for Major Depressive Disorder
Official title Psilocybin With Pimavanserin Compared to Psilocybin Alone for the Treatment of Major Depressive Disorder
ClinicalTrials.gov ID: NCT06592833
What this study is testing
What is Psilocybin?
Psilocybin is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for major depressive disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an interventional, parallel arm assignment treatment study in individuals with Major Depressive Disorder (MDD). Each individual will be treated with a single dose of pimavanserin or placebo plus a single dose of psilocybin.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 80
You may be able to join if
- Age 21-80 years, any gender
- Current primary diagnosis of Unipolar Major Depressive Disorder (MDD) without psychotic features using DSM-5 criteria
- 24-item Hamilton Rating Scale for Depression (HRSD) ≥16
- Current diagnosis of Major Depressive Episode (MDE)
- Capable of providing informed consent and complying with study procedures
You likely can't join if
- Any severity of substance use disorder in the last 6 months (excluding tobacco use disorder) as determined by DSM-V criteria via the SCID
- Current psychiatric hospitalization or psychiatric hospitalization within the last 6 months
- Use of psychedelics in the last 12 months
- Non-medical or illicit use of ketamine in the past 12 months
- Negative reaction after prior use of psychedelics
- Past or current psychotic disorder (including psychotic MDD), mania, or bipolar disorder
See the full eligibility criteria
- Age 21-80 years, any gender
- Current primary diagnosis of Unipolar Major Depressive Disorder (MDD) without psychotic features using DSM-5 criteria
- 24-item Hamilton Rating Scale for Depression (HRSD) ≥16
- Current diagnosis of Major Depressive Episode (MDE)
- Capable of providing informed consent and complying with study procedures
- Currently using or agreeing to use a highly effective contraception, if person of childbearing potential (such as condoms, IUD, or oral contraceptive), for duration of the study. Male participants agree to use highly...
- Discontinuation of any serotonergic drug for at least 2 weeks or 5 half-lives (whichever of the two is longer) prior to psilocybin exposure
- Any severity of substance use disorder in the last 6 months (excluding tobacco use disorder) as determined by DSM-V criteria via the SCID
- Current psychiatric hospitalization or psychiatric hospitalization within the last 6 months
- Use of psychedelics in the last 12 months
- Non-medical or illicit use of ketamine in the past 12 months
- Negative reaction after prior use of psychedelics
- Past or current psychotic disorder (including psychotic MDD), mania, or bipolar disorder
- Severe depression as indicated by Clinical Global Impressions (CGI)-Severity score ≥ 5 at baseline
- Significant suicidal ideation as indicated by C-SSRS \> 2 in the past 6 months at time of screening
- Suicide attempt in the past 2 years, or clinician concern that the patient poses a risk to self or others
- Acute, severe, or unstable medical illness
- Weight \> 300 lbs., or girth size incompatible with scanner bore
- Any conditions/qualities that make participation in MRI imaging unsafe\
- Any physical or intellectual disability adversely affecting ability to complete assessments.
- Current pregnancy or currently breast feeding.
- Any clinically significant abnormal lab test result, including clinically significant abnormal baseline liver and/or renal function tests
- Currently being treated with a contraindicated medication. Contraindicated medications include antipsychotic medications, serotonergic antidepressant medications, and mood stabilizers that may attenuate the effects of...
- History of abnormal QT prolongation or QTc interval \>450 ms on screening
- Use of medications known to prolong the QT interval
- Any congenital prolongation of the QT interval or a family history of long QT syndrome
- A family history of sudden cardiac or unexplained death
- A family history in a first-degree relative of psychosis/schizophrenia or related disorders
- A first-degree family history of bipolar disorder
- A history of cardiac arrhythmias or who require treatment with an antiarrhythmic medication
- A history of any cardiovascular disorder/condition known to increase the possibility of QT prolongation, or any other risk factors for prolonged QT interval/tosades de pointes (including symptomatic bradycardia...
- Preexisting cardiovascular conditions, including cardiac valvulopathy, pulmonary hypertension, hypertension, tachycardia, and any cardiovascular conditions that may be worsened/exacerbated by elevated blood pressure or...
- Baseline vital sign parameters at screening and on day of dosing prior to dose that exceed to the following values for systolic blood pressure (SBP), diastolic (DBP), and heart rate (HR): SBP \> 139 mmHg, DBP 89 mmHg...
- Hypersensitivity to either psilocybin or pimavanserin
- Psychiatric or other condition judged to be incompatible with establishment of rapport with therapy team and/or safe exposure to psilocybin
- Positive urine toxicology at screening
- Any clinically significant abnormalities on 12-lead electrocardiogram (ECG)
- Mini-Mental State Examination (MMSE) score \< 25
- Brief Psychiatric Rating Scale (BPRS-6) \> 5
- Potential fall risk
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.