Depression study: Psilocybin
Official title TRIPS - Treatment to Improve Depression and/or Anxiety Using Psilocybin-assisted Psychotherapy in Cancer Survivors
ClinicalTrials.gov ID: NCT06801041
What this study is testing
What is Psilocybin?
This is an investigational medicine being studied as a potential treatment for depression and anxiety in cancer survivors. It is designed to interact with serotonin receptors in the brain to influence mood and perception.
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 study aims to find out if psilocybin-assisted therapy is safe and effective for treating depression or anxiety in people who have survived cancer.
- Who it's for
- The study is looking for cancer survivors who are currently experiencing depression and/or anxiety.
- What's involved
- Participants will receive psilocybin, a type of medicine, along with therapy sessions to help manage their mental health symptoms.
- Time commitment
- The source text does not specify the duration or number of visits required.
- Phase 2: a mid-size study of how well it works
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
You may be able to join if
- people must have solid or hematological malignancy that does not involve the brain.
- Documentation of current malignancy that was treated and the patient has no evidence of disease in the previous 6 months
- Age ≥ 18 years.
- Have a DSM-V psychiatric diagnosis, as determined by the SCID (Structured Clinical Interview for DSM), of one or more of the following Axis I...
- Have an ECOG performance status of 0, 1, or 2.
You likely can't join if
- Clinically significant suicidality or high risk of completed suicide defined as: i.
- History of bipolar disorder, psychosis (including a history of schizophrenia).
- Functionally limiting comorbid conditions such as second primary malignancies in CNS or chest, and history of total laryngectomy or total glossectomy...
- Postmenopausal (no menses in greater than or equal to 12 consecutive months).
- History of hysterectomy or bilateral salpingo-oophorectomy.
- Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
See the full eligibility criteria
- people must have solid or hematological malignancy that does not involve the brain.
- Documentation of current malignancy that was treated and the patient has no evidence of disease in the previous 6 months
- Age ≥ 18 years.
- Have a DSM-V psychiatric diagnosis, as determined by the SCID (Structured Clinical Interview for DSM), of one or more of the following Axis I psychiatric disorders that is judged to have been precipitated by the...
- Have an ECOG performance status of 0, 1, or 2.
- Must have no major cognitive impairment and be oriented to person, place, and time (e.g. mini mental exam).
- Must demonstrate willingness to travel to MD Anderson Cancer center for all treatment and follow-up sessions, as well as consent to complete all evaluation instruments and assessments.
- Agree to abstain from any nicotine products for at least 8 hours prior to fMRI performance.
- Refrain from any psychoactive drugs (including alcohol) for 48 hours prior to psilocybin sessions and must refrain from psychoactive drugs 12 hours after psilocybin sessions.
- Must be free from any regularly scheduled psychotropic (antidepressant/anxiolytic class) medications for a minimum of 2 weeks prior to study.
- Inhibitors of monoamine oxidase, UGT1A9, 1A10, and aldehyde or alcohol dehydrogenase should be discontinued 5 half-lives prior to active dose of psilocybin.
- Eligible people will have a third-party transportation by a licenses driver (e.g. friend, family or a driver) after the psilocybin session is complete.
- Fluent in Englishria). Ondansetron could be taken but must be stopped at least 24 hours before psilocybin administration.
- Clinically significant suicidality or high risk of completed suicide defined as: i. Answer 'Yes' to C-SSRS Suicidal Ideation items 4 or 5 within the last 2 months at Screening or 'since last visit' at Baseline ii.
- History of bipolar disorder, psychosis (including a history of schizophrenia).
- Functionally limiting comorbid conditions such as second primary malignancies in CNS or chest, and history of total laryngectomy or total glossectomy precluding them from communicating.
- Postmenopausal (no menses in greater than or equal to 12 consecutive months).
- History of hysterectomy or bilateral salpingo-oophorectomy.
- Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
- History of bilateral tubal ligation or another surgical sterilization procedure. Approved methods of birth control are as follows: Hormonal contraception (i.e.
- Persons with first-degree relatives who have schizophrenia or other psychotic disorders, or bipolar I or II disorder diagnosed by a qualified mental health professional.
- Documentation of current malignancy that is being treated with palliative intent.
- Vulnerable populations, including children and cognitively impaired patients, will not be enrolled in this study.
- Patients with brain metastases.
- Risk for hypertensive crisis defined as Screening, Baseline, and Medication Session (day of dosing, prior to dosing) Blood Pressure \>blood pressure \>180/120mmHG, HR \>110 bpm .
- Unstable medical conditions or serious abnormalities of complete blood count, chemistries, or ECG that in the opinion of the study physician would preclude safe participation in the trial. Some examples include: i.
- Significant central nervous system (CNS) pathology. Some examples include: i. Primary or secondary cerebral neoplasm on imaging ii.
The study team makes the final eligibility decision.
Where it is enrolling
- Houston, Texas, United States
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Houston, 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.