Ongoing Studies

We are heavily involved in research on mood and anxiety disorders. While we focus many of our studies on novel therapeutics, we also design studies to help us understand the development, progression, and/or course of a given illness.

Even if we cannot offer you treatment, we hope you will seriously consider participating in one of our studies. Your participation may make it possible for us to help someone with a condition much like yours in the future.

Below is a list of our currently active studies, organized by treatment area or problem.

Multidimensional Brain Connectome Features of Depression and Anxiety

Short Title: Connectome

PI: Yael Jacob, PhD

Funding: National Institute of Mental Health (NIMH)

Description:

Complete 2 study visits; the first is an eligibility screening that can be completed either remotely or in-person, and the second visit will involve a 90-minute brain MRI scan to be completed in person. During the appointments, interviews and clinical self-report scales will be completed.

Basic Inclusion Criteria:

  1. Male or female aged 18-55 years
  2. Meets DSM-5 criteria for current major depressive disorder (MDD), Generalized Anxiety Disorder (GAD), OR does not meet for any current or past psychiatric diagnoses.

Basic Exclusion Criteria:

  1. Any current or history of schizophrenia or other psychotic disorder, neurodevelopmental disorder, or neurocognitive disorder;
  2. Active substance use disorder within the past 6 months;
  3. Positive drug screen at MRI visit.

Study Participation Duration: 2 visits, each lasting up to 6 hours.

Compensation: Up to $150

ISMMS IRB Number: STUDY-22-01245

Pre-Screener Link: REDCap

Neural Circuit-Specific Mechanisms of Ketamine's Effect on Anhedonia and Anxiety in Depression Using Ultra-High Field 7-Tesla MRI

Short Title: SPARK

PI: James Murrough, MD, PhD; Laurel Morris PhD

Funding: National Institute of Mental Health (NIMH)

Description:

This project is designed to examine the role of the subgenual anterior cingulate cortex (sgACC) in anhedonia and anxiety in humans with depression, as well as the acute and sustained effects of ketamine on agACC activation and depression symptoms. All individuals will undergo clinical and behavioral assessment of anhedonia, anxiety, and other depression-relevant domains and task-based MRI with a validated reward task using ultra-high-field 7-Tesla (7T) MRI. Adults with MDD will then be randomized to either a single IV infusion of ketamine or a placebo, and undergo repeated clinical and behavioral assessments and 7T MRI at 1-day and 7-days post-infusion.

Basic Inclusion Criteria

  1. Ages 18-65;
  2. Meets criteria for major depressive disorder or no history of mental illness according to the DSM-5;

Basic Exclusion Criteria:

  1. Meets criteria for schizophrenia or other psychotic disorder;
  2. Substance use disorder within the past 2 years;
  3. Unable to complete an MRI scan.

Study Participation Duration: 6 weeks

Compensation: Up to $1,040

ClinicalTrials.gov ID: NCT06213324

ISMMS IRB Number: STUDY- 23-00648

Pre-Screener Link: REDCap

Rapid Reversal of Suicidal Depression: Comparative Effectiveness of ECT vs. Ketamine Over the Lifespan

Short Title: REaKT

PI: James Murrough, PhD

Funding: Patient-Centered Outcomes Research Institute (PCORI)

Description:

This is a clinical trial where participants are randomly assigned to receive either 4 weeks of electroconvulsive therapy (ECT) or intravenous ketamine treatment for suicidal depression. Participants complete self-report surveys and interviews with study staff before and after treatment.

Basic Inclusion Criteria:

  1. Adults 18-90 years
  2. Meets DSM-5 criteria for Major Depressive Episode (MDE) and are experiencing suicidal ideation or behavior.

Basic Exclusion Criteria:

  1. Any current or history of schizophrenia or other psychotic disorder;
  2. Pregnant or breast-feeding;
  3. Severe uncontrolled medical illness.

Study Participation Duration: Up to 7 months

Compensation: Up to $680

ClinicalTrials.gov ID: NCT06034821

ISMMS IRB Number: STUDY-23-00700

Pre-Screener Link: REDCap

A Randomized-Controlled Trial of Ketamine-Assisted Psychotherapy Compared to Ketamine Alone for Depression

Short Title: KAP

PI: James W. Murrough, M.D., Ph.D.

Study Coordinator: Marcella Corwin, Greta Kandel

Funding: Icahn Mount Sinai School of Medicine

Description:

This is a randomized, controlled clinical trial comparing ketamine-assisted psychotherapy (KAP) to a standard, evidence-based regimen of ketamine administered without psychotherapy (KET). Patients are randomized into either KAP or KET for a treatment phase lasting 4-5 weeks as well as a 2-month follow-up phase post-treatment. The KET arm entails biweekly intravenous ketamine treatments, and the KAP arm entails weekly intramuscular ketamine injections in conjunction with psychotherapy. Both arms require pre- and post-treatment brain MRI scans plus a third follow-up scan.

Basic Inclusion Criteria:

  1. Age 18-90 years;
  2. Meets criteria for major depressive disorder in current major depressive episode according to DSM-5;
  3. Participants may be on medications for depression as long as they remain on a stable dose.

Basic Exclusion Criteria:

  1. Any unstable medical illnesses including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease and uncontrolled hypertension), endocrinology, neurologic, immunologic, or hematologic disease;
  2. Recreational ketamine or phencyclidine use in the last 2 years;
  3. Previous documented non-response to ketamine or esketamine administration, or concurrent treatment with ECT, TMS or VNS, in the current depressive episode

Study Participation Duration: 12 weeks

Compensation: Up to $675

ClinicalTrials.gov ID: NCT06559826

ISMMS IRB Number: STUDY- 23-00661

Pre-Screener Link: REDCap

Investigating the Role of Serotonin in the Mechanism of Action of Psilocybin in Patients with Major Depressive Disorder

Short Title: Psilocybin

PI: James Murrough, MD, PhD

Funding: Icahn School of Medicine at Mount Sinai

Description:

The purpose of this study is to investigate the role of the 5-HT2A receptor in the antidepressant and subjective effects of psilocybin. Participants will be randomly assigned to receive psilocybin with Pimavanserin or psilocybin with a placebo, and will complete 11 study visits that may include brain imaging, blood draws, physical exams, and clinical assessments, either in-person or remotely. One of these visits will involve the administration of psilocybin and either pimavanserin or a placebo.

Basic Inclusion Criteria:

  1. Age 21-80 years, any gender;
  2. Current primary diagnosis of Major Depressive Disorder (MDD) using DSM-5 criteria and current diagnosis of Major Depressive Episode (MDE);
  3. Not currently taking a serotonergic or mood stabilizing drug for at least 2 weeks.

Basic Exclusion Criteria:

  1. Past or current psychotic disorder including MDD, Mania, or Bipolar Disorder with psychotic features;
  2. Any substance use disorder in the last 6 months;
  3. Any psychiatric hospitalization within the last 6 months;
  4. Currently being treated with a contraindicated medication.

Study Participation Duration: Up to 14 weeks.

Compensation: Up to $825

ClinicalTrials.gov ID: NCT06592833

ISMMS IRB Number: STUDY-23-00855

Pre-Screener Link: REDCap

Multidimensional Brain Connectome Features of Depression and Anxiety

Short Title: Connectome

PI: Yael Jacob, PhD

Funding: National Institute of Mental Health (NIMH)

Description:

Complete 2 study visits; the first is an eligibility screening that can be completed either remotely or in-person, and the second visit will involve a 90-minute brain MRI scan to be completed in person. During the appointments, interviews and clinical self-report scales will be completed.

Basic Inclusion Criteria:

  1. Male or female aged 18-55 years
  2. Meets DSM-5 criteria for current major depressive disorder (MDD), Generalized Anxiety Disorder (GAD), OR does not meet for any current or past psychiatric diagnoses.

Basic Exclusion Criteria:

  1. Any current or history of schizophrenia or other psychotic disorder, neurodevelopmental disorder, or neurocognitive disorder;
  2. Active substance use disorder within the past 6 months;
  3. Positive drug screen at MRI visit.

Study Participation Duration: 2 visits, each lasting up to 6 hours.

Compensation: Up to $150

ISMMS IRB Number: STUDY-22-01245

Pre-Screener Link: REDCap

 

 

A Prospective, Multi-center, Randomized Controlled, Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects with Treatment-Resistant Depression.

Short Title: VNS

PI: James Murrough, MD, PhD

Funding: LivaNova

Description:

This is a clinical trial looking at the use of vagus nerve stimulation (VNS) for treatment-resistant bipolar depression. Eligible patients will undergo surgical implantation of the VNS device. The first year of the study is a randomized, controlled, blinded trial, where the participant will either have stimulation or no stimulation. The open-label follow-up begins after the first year, and every participant will receive active VNS for the next 4 years.

Basic Inclusion Criteria:

  1. Meets criteria for bipolar I or II disorder and in a current depressive episode,
  2. Have Medicare insurance,
  3. Documented evidence of inadequate response to at least 4 trials of antidepressant treatments (including psychotherapy, ECT, or TMS);
  4. Currently on a mood stabilizer

Basic Exclusion Criteria:

  1. Acute suicidal risk or recent suicide attempt,
  2. History of borderline or severe personality disorder,
  3. History or diagnosis of rapid cycling bipolar disorder I or II,
  4. Current or lifetime history of psychotic features in any major depressive episode.

Study Participation Duration: 5 years

Compensation: Up to $2,150 baseline (potential for additional compensation)

ClinicalTrials.gov ID: NCT03887715

ISMMS IRB Number: STUDY-19-01400

Pre-Screener Link: REDCap

Multidimensional Brain Connectome Features of Depression and Anxiety

Short Title: Connectome

PI: Yael Jacob, PhD

Funding: National Institute of Mental Health (NIMH)

Description:

Complete 2 study visits; the first is an eligibility screening that can be completed either remotely or in-person, and the second visit will involve a 90-minute brain MRI scan to be completed in person. During the appointments, interviews and clinical self-report scales will be completed.

Basic Inclusion Criteria:

  1. Male or female aged 18-55 years
  2. Meets DSM-5 criteria for current major depressive disorder (MDD), Generalized Anxiety Disorder (GAD), OR does not meet for any current or past psychiatric diagnoses.

Basic Exclusion Criteria:

  1. Any current or history of schizophrenia or other psychotic disorder, neurodevelopmental disorder, or neurocognitive disorder;
  2. Active substance use disorder within the past 6 months;
  3. Positive drug screen at MRI visit.

Study Participation Duration: 2 visits, each lasting up to 6 hours.

Compensation: Up to $150

ISMMS IRB Number: STUDY-22-01245

Pre-Screener Link: REDCap

Neural Circuit-Specific Mechanisms of Ketamine's Effect on Anhedonia and Anxiety in Depression Using Ultra-High Field 7-Tesla MRI

Short Title: SPARK

PI: James Murrough, MD, PhD; Laurel Morris PhD

Funding: National Institute of Mental Health (NIMH)

Description:

This project is designed to examine the role of the subgenual anterior cingulate cortex (sgACC) in anhedonia and anxiety in humans with depression, as well as the acute and sustained effects of ketamine on sgACC activation and depression symptoms. All individuals will undergo clinical and behavioral assessment of anhedonia, anxiety, and other depression-relevant domains and task-based MRI with a validated reward task using ultra-high-field 7-Tesla (7T) MRI. Adults with MDD will then be randomized to either a single IV infusion of ketamine or a placebo, and undergo repeated clinical and behavioral assessments and 7T MRI at 1-day and 7-days post-infusion.

Inclusion Criteria

  1. Ages 18-65;
  2. Meets criteria for major depressive disorder or no history of mental illness according to the DSM-5;

Exclusion Criteria:

  1. Meets criteria for schizophrenia or other psychotic disorder;
  2. Substance use disorder within the past 2 years;
  3. Unable to complete an MRI scan.

Study Participation Duration: 6 weeks

Compensation: Up to $1,040

ClinicalTrials.gov ID: NCT06213324

ISMMS IRB Number: STUDY- 23-00648

Pre-Screener Link: REDCap