Psychedelic Trials

Anxiety

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 at 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


Depression

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 at 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


Trial to Assess the Efficacy, Safety, and Tolerability of Repeated Doses of VLS-01 Buccal Film in Participants with Treatment Resistant Depression

This study is seeking participants with treatment-resistant depression (TRD) to participate in an experimental trial that may offer the potential for substantial improvement in depressive symptoms compared to existing therapies. Study participants will be randomized in a 1:1 ratio to receive two doses of either VLS-01-BU 120mg (DMT/Dimethyltryptamine) or placebo, followed by a 12-week follow-up period. Participants will then be re-randomized to receive another dose of either 120mg or 60mg VLS-01-BU (i.e., no placebo). In its entirety, participation in this trial lasts roughly 5 months.

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

  • Between 18 and 65 years old at screening
  • Have been diagnosed with Major Depressive Disorder (MDD) without psychotic features (recurrent or single-episode)
  • Have not responded to at least two antidepressant medications in the current episode of depression
  • Do not have a history of schizophrenia spectrum disorders, psychotic disorders, or neurocognitive disorders
  • Are able to attend regular in-person visits in Towson, MD

PI: Scott Aaronson, MD

Sponsor: atai Therapeutics 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


Adjustment Disorder and Chronic Illness

Evaluating the Safety and Efficacy of RE104 for Injection in the Treatment of Adjustment Disorder in Patients with Cancer and Other Medical Illnesses

This study is seeking participants with Adjustment Disorder (AjD) and cancer or other illnesses (i.e., ALS, MS, PD, or IPF) to participate in an experimental trial that may offer the potential for significant improvements to depressed mood or mixed depression and anxiety relative to currently available therapies. Participants in this study will be randomized in a 1:1 ratio to receive either 30mg RE104 or 1.5mg RE104 via injection before completing several follow-up visits over a 6-week period. In its entirety, participation in this study lasts roughly 3 months.

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

  • Between 18 and 80 years old at screening
  • Have one of the following medical illnesses: Cancer, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Parkinson’s Disease (PD), or Idiopathic Pulmonary Fibrosis (IPF)
  • Are experiencing depressed mood or mixed anxiety and depressed mood in relation to a medical illness
  • Are able to attend regular in-person visits in Towson, MD

PI: Scott Aaronson, MD

Sponsor: Reunion Neuroscience, 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