Effects of psilocybin with psychological support on anhedonia in treatment-resistant depression

Primary Objective

This study is looking at how psilocybin with therapy affects adults aged 21 years old with anhedonia in depression that hasn’t improved with other treatments compared to a placebo.

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Description

Treatment-resistant depression is a type of depression that doesn’t get better after trying at least two different treatments. A common symptom of major depression is anhedonia, which means not feeling excitement, motivation, or joy. This study looks at how psilocybin with therapy affects anhedonia in people with treatment-resistant depression compared to placebo. A placebo looks like the study drug but doesn’t have any active ingredients.

Main Procedures Involved: If you join this study, you will be randomly put into a group. One group will get psilocybin, and the other group will get a placebo. You won’t get to choose which group you will be in. It’s like flipping a coin. If you’re in either group, you will receive support from study therapists before, during, and after taking the study medication. You will also have a physical exam, blood tests, two MRIs, and psychological tests. You will fill out several surveys during the study too.

Duration of Participation: You will have 14 to 24 study visits, and the study will last 12 to 25 weeks. You will need to come to the University of Colorado Anschutz Medical Campus in Aurora for 8 to 13 in-person visits. The other visits can be done online. You may need to stop taking some medications during the study.

Details
Age
21 to 75 years
Eligibility
You may join this study if: 
  • You have depression that hasn’t improved with other treatments (treatment-resistant depression).
  • You are 21 years old or older.
  • You are right-handed.
  • You can read, write, and speak in English.
  • You see a psychiatric doctor or have a doctor at UC Health or CU Medicine (like a primary care doctor, neurologist, therapist).
  • You have a flexible schedule for several in-person visits during business hours.
You can’t join this study if: 
  • You are pregnant.
  • You weigh more than 300 pounds.
  • You have metal in your body (like a pacemaker).
  • You have heart valve disease.
The study team will check more requirements at your first visit.
Locations

Brain Imaging Center (BIC)
Outpatient CTRC

Principal Investigator
Photograph of Andrew Novick

Andrew Novick

Study ID

Protocol Number: 22-1681

More information available at ClinicalTrials.gov: NCT06230757

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