Treatment Resistant Depression study: Psilocybin vs Low-dose psilocybin
Official title Psilocybin rTMS for Treatment Resistant Depression
ClinicalTrials.gov ID: NCT06132178
What this study is testing
What is Psilocybin?
Psilocybin is an investigational medicine, taken by mouth once daily, being studied as a potential treatment for treatment resistant depression.
Also referred to as COMP360.
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 purpose of this study is to determine the safety and feasibility of sequencing psilocybin therapy with a short-duration, aiTBS protocol (Stanford Accelerated Intelligent Neuromodulation Therapy, or SAINT) in individuals with treatment-resistant major depressive disorder.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 65
You may be able to join if
- Adults, ages 22-65.
- English language comprehension suitable to understand experimenter instructions and to communicate to study personnel/staff reasonably easily.
- Current major depressive episode (without psychotic features), either as part of recurrent major depressive disorder (MDD) or single episode MDD with...
- Montgomery Asberg Depression Rating Scale (MADRS) score of 20 or greater at baseline assessment (at least moderate severity).
- 1\. Treatment-resistant MDD, defined as either: a) failure to respond to an adequate dose and duration of two or more pharmacological treatments...
You likely can't join if
- Prior history or current diagnosis of a psychotic disorder (including MDD with psychotic features), bipolar disorder, or personality disorder (based...
- Current diagnosis of posttraumatic stress disorder, acute stress disorder, obsessive-compulsive disorder, anorexia nervosa, bulimia nervosa, or...
- Having met criteria for an alcohol or substance-use disorder within the past year.
- Use of electroconvulsive therapy, deep brain stimulation, or vagus nerve stimulation during the current major depressive episode.
- Any prior rTMS treatment (10Hz, 5Hz, 1Hz, or conventional intermittent theta burst).
- Current participation in an evidence-based psychotherapy for major depression (e.g., cognitive behavioral therapy, behavioral activation).
See the full eligibility criteria
Who can join
- Adults, ages 22-65.
- English language comprehension suitable to understand experimenter instructions and to communicate to study personnel/staff reasonably easily.
- Current major depressive episode (without psychotic features), either as part of recurrent major depressive disorder (MDD) or single episode MDD with current episode present for at least the past 3 months (as determined...
- Montgomery Asberg Depression Rating Scale (MADRS) score of 20 or greater at baseline assessment (at least moderate severity).
- 1\. Treatment-resistant MDD, defined as either: a) failure to respond to an adequate dose and duration of two or more pharmacological treatments, with at least one failed medication trial occurring in the current major...
- Willingness and ability to attend daily, full-day visits to the research site for a period of \~2 weeks and to participate in all study procedures (clinical assessments, treatments, and neurobiological assessments).
- If currently taking an antidepressant medication (an SSRI, SNRI, or atypical antidepressant), antipsychotic, and/or other augmenting medication (e.g., lithium), willingness to discontinue medication(s) over a 2-8 week...
What rules you out
- Prior history or current diagnosis of a psychotic disorder (including MDD with psychotic features), bipolar disorder, or personality disorder (based on medical history, clinician judgement, SCID-5 and/or SCID for...
- Current diagnosis of posttraumatic stress disorder, acute stress disorder, obsessive-compulsive disorder, anorexia nervosa, bulimia nervosa, or alcohol or substance-use disorder.
- Having met criteria for an alcohol or substance-use disorder within the past year.
- Use of electroconvulsive therapy, deep brain stimulation, or vagus nerve stimulation during the current major depressive episode.
- Any prior rTMS treatment (10Hz, 5Hz, 1Hz, or conventional intermittent theta burst).
- Current participation in an evidence-based psychotherapy for major depression (e.g., cognitive behavioral therapy, behavioral activation).
- Exhibiting significant suicide risk within the past 12 months, at screening, or at baseline, as evidenced by: a) suicidal ideation with some intent to act but no specific plan (item #4 from the Columbia Suicide Severity...
- Major depressive episode that is secondary to a medication or a general medical condition, as judged by investigators.
- Any other factors, such as major medical conditions, unstable housing or threatening life circumstances, erratic behavior, etc.
- Prior past-year ingestion of a serotonergic psychedelic, e.g., psilocybin, LSD, mescaline, dimethyltryptamine, etc. or more than 5 lifetime ingestions of a serotonergic psychedelic on separate occasions.
- Participant unwillingness to not ingest or use additional serotonergic psychedelics outside the context of study procedures for the duration of the study follow-up period (12 months).
- Ferrous metal, metallic implants, or implanted medical devices that would preclude administration of rTMS and/or participation in MRI procedures, including but not limited to: cochlear implants, implanted brain...
- Past history of seizures or epilepsy (rTMS risk).
- Neurological disorder, including epilepsy, stroke, or history of brain surgery.
- Past penetrating brain injury or any head injury resulting in a loss of consciousness for 30 minutes or more or post-concussive symptoms for more than seven days following a head injury.
- Head injury in the past two months, regardless of severity.
- Currently pregnant and/or nursing or about to become pregnant. A positive urine pregnancy test at screening and/or baseline will lead to participant exclusion from the study.
- Engagement in sexual intercourse which could result in pregnancy without use of a highly effective contraceptive method throughout participation in the study and for at least three months after COMP360 (psilocybin)...
- Severe claustrophobia (prohibiting MRI acquisition).
- Uncontrolled hypertension (resting blood pressure \> 140/90 mm hg).
- Uncontrolled thyroid disease as indicated by unstable thyroid hormone dosage \< 3 months prior to screening, or abnormal and clinically significant thyroxine (FT4) levels (a free FT4 measurement will be conducted for...
- Lifetime history of cardiomyopathy, stroke, heart disease, heart attack, tachycardia, elongated QT-interval corrected by Friderichia (\> 450ms for men and \> 470ms for women)
- Type I diabetes mellitus or uncontrolled Type II diabetes mellitus (defined by hemoglobin A1c \> 8% at screening) or a history of diabetic ketoacidosis, hyperglycemic coma, or severe hypoglycemia with loss of...
- Positive urine drug screening for drugs of abuse at screening and/or baseline will trigger a review with participant and assessment for eligibility based on pattern of use and willingness to abstain in conjunction with...
- Clinically-significant results from physical examination, blood test, urine test, vital signs, or ECG at screening and/or baseline.
- Current enrollment in another treatment study or participation within such a study within 6 months of screening.
- Self-reported hypersensitivity to psilocybin or another serotonergic psychedelic.
The study team makes the final eligibility decision.
Where it is enrolling
- Austin, Texas, 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, but 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, 22 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Austin, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.