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New treatment option for Transdiagnostic
Official title Open-Label Psilocybin Study in Transdiagnostic Population
ClinicalTrials.gov ID: NCT06442423
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 transdiagnostic.
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
- The primary objective of this study is to investigate the safety, feasibility, and tolerability of psilocybin treatment in individuals with functional impairment due to psychiatric symptoms. The secondary objective of this study is to determine whether individuals with functional impairments due to psychiatric symptoms will experience statistically significant symptom reduction and functional improvement from baseline symptom measurements (Visit 3) to 1-week (Visit 7), 4-weeks (Visit 8), and 6-weeks (Visit 9) post dosing.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- At least one psychiatric symptom causing functional impairment over the past 30 days as established by a trained rater on the DIAMOND (at least...
- English fluency - able to understand the process of consent and the risk and benefits associated with the study, and able to provide written (signed...
- Agree to set up safe transportation after leaving the site following the dosing session. Acceptable arrangements include: arranging for a...
- Must be able to identify a physician/treater that can be contacted to further assure that it is safe for the subject to participate and agree to sign...
- Ability to orally ingest pills for psilocybin dosing visit.
You likely can't join if
- Psychiatric Exclusion Criteria:
- Personal history of a primary psychotic disorder (e.g., schizophrenia, delusional disorder, schizoaffective disorder) or Bipolar I disorder, or at...
- Active suicidal intent or suicidal or non-suicidal self-injurious behaviors, as defined by a "yes" response to question 4 on C-SSRS within the past 6...
- Use of a classic psychedelic (i.e., LSD, psilocybin, DMT, mescaline) within the 3 months prior to enrollment (not including microdosing).
- Use of ketamine within the past month at Screening.
- History of regular and frequent use of a classic psychedelic (more than 10 times per year) in a structured, intentional setting over the past 10...
See the full eligibility criteria
Who can join
- At least one psychiatric symptom causing functional impairment over the past 30 days as established by a trained rater on the DIAMOND (at least "mild" impairment) and/or the WHODAS-2.0 12-item (a raw score of \>16) -...
- English fluency - able to understand the process of consent and the risk and benefits associated with the study, and able to provide written (signed and dated) informed consent form.
- Agree to set up safe transportation after leaving the site following the dosing session. Acceptable arrangements include: arranging for a friend/family member to drive them home, pick them up and escort them home; if...
- Must be able to identify a physician/treater that can be contacted to further assure that it is safe for the subject to participate and agree to sign a medical release for the investigators to communicate directly with...
- Ability to orally ingest pills for psilocybin dosing visit.
- Must provide an adult contact (relative, spouse, close friend or other caregiver) who is willing and able to be reached by the PI and/or study personnel in the event of an emergency, and who can provide transportation...
- Be psychologically stable: Concurrent psychotherapy is allowed if the type and frequency of the therapy has been stable for at least one month prior to screening and is expected to remain stable during participation in...
- If participant is of childbearing potential, must agree to use adequate birth control and not attempt to become pregnant during study up to 4 weeks post dosing session (see Section 6.3.3). If participant is of...
- Premenarchal.
- Premenopausal with 1 of the following:
- Documented hysterectomy or bilateral salpingectomy/tubal occlusion/oophorectomy.
- Postmenopausal.
- A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
- Females receiving hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use 1 of the nonhormonal, highly effective contraception methods if they wish to continue their HRT during...
What rules you out
- Psychiatric Exclusion Criteria:
- Personal history of a primary psychotic disorder (e.g., schizophrenia, delusional disorder, schizoaffective disorder) or Bipolar I disorder, or at least one first-degree relative with a diagnosis of primary psychotic...
- Active suicidal intent or suicidal or non-suicidal self-injurious behaviors, as defined by a "yes" response to question 4 on C-SSRS within the past 6 months at screening or prior to dosing (Active Suicidal Ideation with...
- Use of a classic psychedelic (i.e., LSD, psilocybin, DMT, mescaline) within the 3 months prior to enrollment (not including microdosing).
- Use of ketamine within the past month at Screening.
- History of regular and frequent use of a classic psychedelic (more than 10 times per year) in a structured, intentional setting over the past 10 years. Structured use refers to participation in organized retreats...
- History of Other Hallucinogen Use Disorder.
- History of intolerance to drugs known significantly to alter perception (i.e., psilocybin, LSD, salvinorium A, mescaline).
- Patients taking 5-hydroxytryptophan or St. John's Wort
- A positive breathalyzer test
- A positive urine toxicology screening, which detects the standard panel of five drugs (marijuana, cocaine, opioids/opiates, amphetamines, and phencyclidine (PCP)), as well as benzodiazepines...
- Changes to psychotropic medication and/or dosages within the past 3 months.
- Current or recent (within 2 weeks of enrollment) prescription of MAOI, Lithium, and/or methadone use.
- Has a psychiatric condition that precludes the establishment of therapeutic rapport as evidenced by long-term patterns of unstable relationships, a history of significant stress- related paranoia, or identity...
- Use of any other investigational drugs within 30 days prior to Screening.
- Allergy to gelatin. General Medical/Laboratory Exclusion Criteria:
- Hypertension at screening is defined as: systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg, on the lowest of three measurements.
- History of cardiovascular disease, including but not limited to clinically significant coronary artery disease, cardiac hypertrophy, cardiac ischemia, congestive heart failure, myocardial infarction, angina pectoris...
- Any clinically significant abnormal electrocardiogram (ECG) finding, such as findings suggestive of ischemia or infarct, complete bundle branch block, atrial fibrillation or other symptomatic arrhythmias, or...
- Resting QT interval with Fridericia's correction (QTcF) ≥ 450 msec (male) or ≥ 470 msec a. (female) at Screening, or inability to determine QTcF interval.
- Presence of risk factors for torsades de pointes, including: long QT syndrome, uncontrolled hypokalemia or hypomagnesemia, history of cardiac failure, history of clinically significant/symptomatic bradycardia, family...
- Moderate-to-severe hepatic impairment, defined as a Child-Pugh score ≥ 5, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2 x the upper limit of normal (ULN), or bilirubin \> 1.5 x ULN, unless this...
- Use of vasoconstrictive medications (i.e. sumatriptan, pseudoephedrine, midodrine) within 5 half-lives of test days and use of steroids or certain other immunomodulatory agents (i.e. azathioprine) in the past 2 weeks.
- Moderate-to-severe renal impairment, defined as an estimated glomerular filtration rate of \< 50 mL/min/1.73 m2 at Screening
- Uncontrolled diabetes with an HbA1c \> 8
- Significant uncontrolled hypothyroidism (thyroid stimulating hormone [TSH] \ 1.5 x upper Any other condition, disorder or finding which in the opinion of the investigator would adversely impact participant safety or the...
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, 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, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, 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.