Psilocybin Trials

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
    • 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.

Interested in participating? Please complete this survey to get in touch with the IADT research team. Upon completion, the team will review your responses and may reach out to further explore your suitability for the trial.

Survey not working, or inquiring for a different reason? Please reach out to study staff at IADTClinicalTrials@sheppardpratt.org


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. 

Interested in participating? Please complete this survey to get in touch with the IADT research team. Upon completion, the team will review your responses and may reach out to further explore your suitability for the trial.

Survey not working, or inquiring for a different reason? Please reach out to study staff at IADTClinicalTrials@sheppardpratt.org


Psilocybin in the Treatment of Tobacco Use Disorder

This study is seeking volunteers interested in quitting smoking to participate in a multi-site, double-blind clinical trial involving psilocybin. Participants in this study will be randomized to receive either two doses of oral psilocybin or two doses of oral niacin (placebo), with dosing sessions 1 week apart. Participation in the study lasts approximately 1 year, though the frequency of study visits decreases significantly after the first ~3 months.

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

  • Are 21 years or older
  • Are a daily cigarette smoker (minimum of 5 cigarettes/day on a typical day) with a desire to quit smoking
  • Are not taking any antidepressants, antipsychotics, MAO inhibitors, or serotonin-acting dietary supplements on a regular basis (e.g., daily)
  • Do not have any major health concerns, including uncontrolled hypertension/high blood pressure

PI: Matthew Johnson, PhD

Sponsor: National Institutes of Health (NIH)

Learn more about this study.

Interested in participating? Please complete this survey to get in touch with the IADT research team. Upon completion, the team will review your responses and may reach out to further explore your suitability for the trial.

Survey not working, or inquiring for a different reason? Please reach out to study staff at IADTClinicalTrials@sheppardpratt.org


LSD Trials

Evaluating the Efficacy and Safety of Oral MM120 Compared to Placebo in the Treatment of Adults with Generalized Anxiety Disorder

This study is seeking participants with generalized anxiety disorder (GAD) to participate in a research trial that may offer the potential for a substantial improvement in anxiety symptoms over existing therapy. The study has a 12-week double-blind phase in which participants are randomized to receive one of two potential doses of MM120 (semisynthetic LSD; 100µg or 50µg) or placebo, followed by a 40-week open-label phase in which all participants have the chance to receive up to four 100µg doses of MM120.

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

  • Between 18 and 74 years old screening
  • Meet diagnostic criteria for Generalized Anxiety Disorder
  • Are not currently depressed, and have not been diagnosed with bipolar disorder, post-traumatic stress disorder, a personality disorder, or a psychotic disorder (e.g., schizophrenia, schizoaffective disorder)
  • Do not have any major health concerns, including uncontrolled hypertension/high blood pressure
  • Are able to attend regular in-person visits in Towson, MD

PI: Scott Aaronson, MD

Sponsor: Mind Medicine Inc.

Interested in participating? Please complete this survey to get in touch with the IADT research team. Upon completion, the team will review your responses and may reach out to further explore your suitability for the trial.

Survey not working, or inquiring for a different reason? Please reach out to study staff at IADTClinicalTrials@sheppardpratt.org


Evaluating the Efficacy and Safety of Oral MM120 Compared to Placebo in the Treatment of Adults with Major Depressive Disorder

This study is seeking participants with major depressive disorder (MDD) to participate in a research trial that may offer the potential for a substantial improvement in depressive symptoms over existing therapy. The study has a 12-week double-blind phase in which participants are randomized to receive either 100µg MM120 (semisynthetic LSD) or matching placebo, followed by a 40-week open-label phase in which all participants have the chance to receive up to four 100µg doses of MM120.

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

  • Between 18 and 74 years old screening
  • Meet diagnostic criteria for Major Depressive Disorder and are currently experiencing a depressive episode
  • Have not been diagnosed with bipolar disorder, post-traumatic stress disorder, a personality disorder, or a psychotic disorder (e.g., schizophrenia, schizoaffective disorder)
  • Do not have any major health concerns, including uncontrolled hypertension/high blood pressure
  • Are able to attend regular in-person visits in Towson, MD

PI: Scott Aaronson, MD

Sponsor: Mind Medicine Inc.

Interested in participating? Please complete this survey to get in touch with the IADT research team. Upon completion, the team will review your responses and may reach out to further explore your suitability for the trial.

Survey not working, or inquiring for a different reason? Please reach out to study staff at IADTClinicalTrials@sheppardpratt.org


Other Studies

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