Treatment-Resistant Depression – Investigational Nasal Spray

This outpatient double blind study will evaluate the efficacy, safety, and tolerability of an investigational nasal spray administered as monotherapy versus placebo in adults with treatment-resistant depression.

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 must be ≥ 2 years
  • Must have ≥ 2 failed antidepressant treatments in the current depressive episode
  • Must not have had prior lifetime ketamine/esketamine use

PI: Scott Aaronson, MD

Sponsor: Janssen Research & Development, LLC

Contact: To participate in this study or for more information, contact Sam Rudow at srudow@sheppardpratt.org or call 410-938-3126


Treatment-Resistant Depression – Esketamine and App Supported Cognitive Behavioral Therapy

This outpatient open-label study will evaluate the feasibility of esketamine supplemented by app driven cognitive behavioral therapy in adults with treatment-resistant depression.

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

  • Between the ages of 18 and 65
  • Own a smartphone
  • Meet diagnostic criteria for single-episode or recurrent Major Depressive Disorder
  • Must have failed ≥ 2 different oral antidepressant treatments in the current episode
    • Must be currently taking an oral antidepressant
  • Must not have had an adequate course of ketamine/esketamine for depression
  • Must not have had prior sustained CBT (consistent treatment for > 6 weeks) within 3 months of entering the study

PI: Scott Aaronson, MD

Sponsor: Janssen Research & Development, LLC

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


Treatment Resistant Depression – Vagus Nerve Implant

This randomized, double-blind study will evaluate the safety and effectiveness of implanted VNS Therapy® System as adjunctive therapy versus a no stimulation control for subjects with treatment-resistant depression.

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

  • 18 years or older
  • Have a current diagnosis of Major Depressive Disorder
  • Must have failed ≥ 4 antidepressant treatments in current depressive episode
  • Must have Medicare insurance

PI: Scott Aaronson, MD

Sponsor: LivaNova

Contact: To participate in this study or for more information, contact MacKenzie Forbes at mforbes@sheppardpratt.org or call (410) 938-3135.


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


Psilocybin for 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.

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, Ltd

Contact: To participate in this study or for more information, contact Sam Rudow at srudow@sheppardpratt.org or call 410-938-3126. You can also contact Audrey Shoultz at audrey.shoultz@sheppardpratt.org or call 410-938-5263.


Psilocybin for Type-II Bipolar Depression

This study will evaluate the efficacy and safety of a single open-label dose of psilocybin administered under supportive conditions to adults with type-II bipolar depression in improving depressive symptoms.

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

  • Between 18 and 65 years old
  • Meet diagnostic criteria for type-II bipolar depression, current episode depressed
  • Must have ≥ 2 failed antidepressant treatments in the current depressive episode
  • Must be able to accommodate multiple in-clinic visits in Towson, MD

PI: Scott Aaronson, MD

Sponsor: COMPASS Pathways, Ltd.

To participate in this study or for more information, contact Sam Rudow at srudow@sheppardpratt.org or call 410-938-3126. You can also email Tammy Miller at tmiller1@sheppardpratt.org or call 410-938-3141.


Major Depressive Disorder (MDD) - Nerve Stimulator Study (MOOD)

This randomized, double-blind study will evaluate the safety and effectiveness of self-administered treatment for major depressive disorder using an external combined occipital and trigeminal nerve stimulator (Relivion® DP).

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

  • Between 18 and 70 years old
  • Primary diagnosis of Major Depressive Disorder (MDD)
  • Current MDD episode lasts up to three (3) years
  • Failed at least one (1) but no more than four (4) adequate trials of antidepressant medications

PI: Scott Aaronson, MD

Sponsor: Neurolief

To participate in this study, contact MacKenzie Forbes at mforbes@sheppardpratt.org or call 410-938-3135.