Efficacy, Safety, and Tolerability of COMP360 in Participants with Treatment-Resistant Depression 

This outpatient double blind, placebo-controlled study will evaluate the efficacy, safety, and tolerability of COMP360 (synthetic psilocybin) administered with psychological support in participants with treatment-resistant depression. The study comprises three parts (A, B, and C) and will last approximately 62 weeks including a three- to ten-week screening period.

Eligibility: We are currently seeking participants who meet the following criteria

• 18 years or older

• Meet diagnostic criteria for Major Depressive Disorder at screening, with symptoms that have been present for ≥ 4 weeks

o If single episode MDD, the episode duration be ≥3 months and ≤2 years at screening.

• Must have ≥ 2 failed antidepressant treatments in the current depressive episode

• At screening, agreement to discontinue all prohibited medications

• Must be able to accommodate multiple in-clinic visits in Towson, MD

PI: Scott Aaronson, MD

Sponsor: COMPASS Pathways

Learn more about this study.

Contact: To participate in this study or for more information, contact IADT Clinical Trials at IADTclinicaltrials@sheppardpratt.org or call Kim Swartz at 410-938-3139.


 

Treatment-Resistant Depression and Chronic Suicidal Ideation

This study will evaluate the efficacy and safety of a single-open label dose of psilocybin administered under supportive conditions to adults with treatment-resistant depression and chronic suicidal ideation in improving depressive symptoms. The study lasts between 15-18 weeks.

Eligibility: We are currently seeking participants who meet the following criteria

• Between 18 and 65 years old at screening

• Meet diagnostic criteria for single-episode or recurrent Major Depressive Disorder

• Must have presence of suicidal thoughts with active ideation

• Must have failed ≥ 2 failed antidepressant treatments in the current episode

• Must be able to accommodate multiple in-clinic visits in Towson, MD

PI: Scott Aaronson, MD

Sponsor: COMPASS Pathways

Learn more about this study. 

Contact: To participate in this study or for more information, contact IADT Clinical Trials at IADTclinicaltrials@sheppardpratt.org or call Audrey Shoultz at 410-938-5263.


 

Efficacy and Safety of COMP360 in Anorexia Nervosa

This study aims to explore the efficacy and safety of COMP360 25mg as compared to COMP360 1mg (control condition) administered with psychological support in participants with Anorexia Nervosa.

Eligibility: We are currently seeking participants who meet the following criteria

• 18 years or older

• Meet criteria for AN either restrictive or binge-purging type, according to the DSM-5, based on medical records, clinical assessments, and BMI

• History of disordered eating with duration of at least 3 years prior to screening

• One documented prior attempt at treatment in the past 3 years

• BMI ≥15 kg/m2 and ≤20 kg/m2

PI: Scott Aaronson, MD

Sponsor: COMPASS Pathways

Learn more about this study. 

Contact: To participate in this study or for more information, contact IADT Clinical Trials at IADTclinicaltrials@sheppardpratt.org or call Audrey Shoultz at 410-938-5263.


Bipolar Depression - A trial of an add-on probiotic to prevent relapse and improve the clinical course after hospitalization for bipolar depression

This study is seeking volunteers for a clinical trial that may help prevent readmission for an exacerbation of psychiatric symptoms. Participants take add-on probiotics or placebo for 24 weeks and are compensated for their time. 

Probiotic supplements contain tiny healthy organisms similar to those found in breast milk, yogurt, and some other foods. They are thought to provide health benefits by improving digestion and modulating the immune response.  

Eligibility

  • Currently or recently admitted to an inpatient or day hospital program for symptoms of bipolar depression, and with a diagnosis of Bipolar I or II disorder
  • 18 - 65 years old
  • Available for follow-up phone calls weekly and in-person visits every four weeks at Sheppard Pratt's Towson campus during a 24-week treatment period

PI: Faith Dickerson, PhD, MPH

Founding source: Stanley Medical Research Institute

For further information please contact Emily Katsafanas at ekatsafanas@sheppardpratt.org

Learn more about this study.


Schizophrenia - A trial of an add-on synbiotic to reduce psychiatric symptoms 

This study is seeking volunteers for a clinical trial that may help reduce psychiatric symptoms of schizophrenia or schizoaffective disorder. 

Participants take an add-on synbiotic supplement or placebo for 14 weeks and are compensated for their time. 

Synbiotic supplements contain probiotics which are tiny healthy organisms similar to those found in breast milk, yogurt, and some other foods, and a prebiotic which helps “good” bacteria to grow in the digestive tract. Probiotics and prebiotics are thought to provide health benefits by improving digestion and modulating the immune response.  

Eligibility

  • Currently receiving outpatient treatment with a diagnosis of Schizophrenia or Schizoaffective Disorder.
  • Receiving the same dose of antipsychotic medication for at least 8 weeks
  • 18 - 65 years old
  • Available for in-person visits every two weeks during a 14-week treatment period

PI: Faith Dickerson, PhD, MPH

For further information please contact Emily Katsafanas at ekatsafanas@sheppardpratt.org