Ongoing Studies

We are heavily involved in research on depression, post-traumatic stress disorder, and other mood and anxiety conditions. While we focus many of our current studies on novel therapeutics, we also design studies to help us understand the development, progression, and/or course of a given illness. We cannot always offer you a specific treatment, but we hope that your participation in our research might at least inform our understanding of the nature of mood and anxiety disorders. As participants, you make critical contributions to our ability to understand how mood and anxiety disorders work. We know many people come to us hoping to feel better; we do our best to help those who do. Even if we can’t 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.

PCORI ELEKT-D: ECT vs Ketamine Trial

PI: James Murrough, MD, PhD   

Study Coordinator: Mora Grehl     

Funding: Patient Centered Outcomes Research Institute (PCORI)

Description: This is a multi-site randomized trial of electroconvulsive therapy (ECT) versus Ketamine for patients with treatment resistant depression (TRD). Patients will be randomized to receive ECT 3 times per week or ketamine 2 times per week over the course of 3-5 weeks.

Main Inclusion: Primary MDD (unipolar) diagnosis, at least 2 trials of antidepressants and/or augmentation strategies, willing to receive either ECT or ketamine, medically healthy, between ages 21-75

Main Exclusion: Bipolar Disorders, psychotic symptoms in the current episode, diagnosis of a psychotic disorder

Study Participation Length: acute phase 4 weeks, follow up 6 months

Compensation: Yes

Clinicaltrials.gov ID: NCT03113968 

 

Developing Neural KCNQ Channel Modulators for Mood Disorders

PI: James Murrough, MD, PhD   

Study Coordinator: Morgan Harnois     

Funding: National Institute of Mental Health

Description: This is a multi-site randomized trial investigating the effects of an FDA approved medication called Ezogabine in those with depressive disorders like MDD. Patients are randomized to receive either Ezogabine or placebo oral medication over the course of 8 weeks. This study includes two fMRI scans which each take roughly one hour to complete, one before beginning the study medication and the second after taking 5 weeks of medication.

Main Inclusion: Primary MDD (unipolar) diagnosis, medically healthy, able to swallow oral tablets, between ages 18-65

Main Exclusion: MRI contraindications (e.g. metal in the body), Bipolar Disorders, psychotic symptoms in the current episode, diagnosis of a psychotic disorder

Study Participation Length: Medication phase: 8 weeks; Total study length 10-14 weeks

Compensation: Yes

Clinicaltrials.gov ID: NCT03043560 

 

Pharmacologic Attenuation of Ketamine Using Nitroprusside  

PI: James Murrough, MD, PhD   

Study Coordinator: Charlotte Pierce     

Funding: Ichan School of Medicine at Mount Sinai

Description: This study investigates the use of two substances given intravenously, ketamine and nitroprusside, in adults with MDD. This study is investigating the use of nitroprusside to mitigate the side-effects of ketamine by administering the drugs simultaneously. The study consists of two separate infusions of ketamine spaced two weeks apart, plus either nitroprusside or placebo during each ketamine infusion.

Main Inclusion: Medically healthy adults ages 21-65 with primary MDD (unipolar) diagnosis

Main Exclusion: Bipolar Disorders, Psychotic Disorders, Eating Disorders, any current anti-depressant medications

Study Participation Length: This study consists of 8 visits over 10 weeks. Ketamine infusions are all-day visits lasting from 7:45am till 3:30pm

Compensation: Yes

Clinicaltrials.gov ID: NCT03102736

 

A Randomized, Double-blind, Placebo-controlled, Multicenter, Efficacy and Safety Study of Rapastinel for Rapid Treatment of Symptoms of Depression and Suicidality in Adult Patients with Major Depressive Disorder

PI: James Murrough, MD, PhD

Study Coordinator: Molly Schneider

Funding: Allergan

Description: The purpose of this study is to look into the safety and efficacy of Rapastinel in treating severe depression in psychiatric inpatients at Mount Sinai. The study is a randomized, double-blind, placebo-controlled trial, which means that participants have a 50% chance of receiving Rapastinel and 50% chance of receiving placebo. The length of participants’ hospital stay is determined by the study doctor. Participants will undergo up to 4 injections during the study administered weekly, several of which will occur after discharge from the hospital. After the last treatment there will be a safety follow-up one week later.

Inclusion: 18 – 65 years old, Patients in a current major depressive episode, Inpatients admitted to Mount Sinai for suicidality

Exclusion: Any psychiatric disorder other than Major Depressive Disorder as the main reason for recent medical treatment.

Study Participation Length: 11 study visits over a period of approximately 35 days.  Participants may need to attend additional unscheduled visits for safety or other reasons.

Compensation: Yes

Clinicaltrials.gov ID: NCT03352453

 

7T MRI to reveal structural, connectomic and metabolic imaging markers for the neurobiology of Depression

PI: Priti Balchandani, PhD

Study Coordinator: Molly Schneider

Funding: National Institute of Mental Health

Description: The purpose of this study is to develop and apply a comprehensive 7 Tesla MRI protocol to better understand brain function in mood disorders such as depression. We expect to learn the best use of this new technology in finding and defining suspected disease of normal anatomy and function.

Inclusion: 18 – 65 years old, Healthy volunteers OR Patients in a current major depressive episode

Exclusion: Lifetime history of psychotic features, diagnosis of schizophrenia, diagnosis of bipolar disorder, MRI contraindications (e.g. metal in the body), Individuals currently taking antidepressant medication

Study Participation Length: Two 2-3 hour visits.

Compensation: Yes

Neuro-Immune Biotypes of Depression: Towards Pathophysiology-Based Diagnosis and Personalized Treatment

PI:  James Murrough, MD, PhD   

Study Coordinator: Abigail Collins

Funding: Charles A. Dana Foundation

Description: The current study aims to integrate advanced assessments of the brain, the immune system and of clinical symptoms in patients with major depressive disorder (MDD) in order to ultimately understand whether there are unique subgroups of MDD. Other recent studies suggest that stress impacts the blood-brain barrier (BBB), which is a protective barrier between the brain and the blood. BBB damage caused by stress might allow certain immune system proteins to enter the brain that wouldn't normally. This infiltration might alter brain activity and may lead to MDD. This study will use advanced brain imaging techniques at the 7T level (magnetic resonance imaging, MRI) to understand the relationships between BBB damage, the immune system and brain function in MDD and healthy non-depressed volunteers. If successful, the proposed project will advance our understanding of MDD and may point out specific sub-groups of MDD that may benefit from more specific treatments.

Inclusion criteria: Male or female from 18-55 years who meet DSM-V criteria unipolar major depressive disorder OR Healthy Volunteers who do not meet for any current or past psychiatric diagnoses as defined by DSM-V criteria;       

Exclusion criteria: Diagnosis psychotic disorder, neurodevelopmental disorder, or neurocognitive disorder, current use of any psychiatric medication, any diagnosed inflammatory or autoimmune disorder, any contraindications to MRI

Study Participation Length: Up to 4 weeks (2-3 visits)

Compensation: Yes

 

Stress and Atherosclerotic Plaque Macrophages: A Systems Biology Approach – PET/MRI of the Brain-Hematopoiesis-Atherosclerosis Axis in PTSD Patients

PI: Zahi Fayad, PhD and James Murrough, MD, PhD

Study Coordinator: Brittany Cho

Funding: National Institute of Health

Description: This is a two-center five-year prospective observational study examining the effect of PTSD on vascular inflammation, proliferation, and plaque burden. The study centers will be TMII at Mount Sinai and the Athinoula A. Martinos Center for Biomedical Imaging at MGH. This Project will include two study visits: one screening visit and one imaging visit, to be completed in two different days and within 4 weeks apart.

Three groups of individuals will be recruited:

  • Group 1 includes diagnosed PTSD subjects from at least 1 year prior to enrollment
  • Group 2 (trauma control group) includes control subjects who have been exposed to trauma without developing PTSD symptoms from at least 1 year prior to enrollment
  • Group 3 (healthy control group) individuals who have neither PTSD nor exposure to trauma

Main Inclusion:

  1. Male or female aged 30-65 years
  2. Does not meet for any current or past psychiatric diagnoses as defined by DSM-V criteria (Healthy Control)OR Meets DSM-V criteria for PTSD from at least 1 year prior to enrollment (PTSD) OR meets DSM-V criteria A of PTSD without satisfying criteria for a PTSD diagnoses according to the DSM-V from at least 1 year prior to enrollment (Trauma Control)
  3. Have a level of understanding of the English language sufficient to agree to all tests and examinations required by the study and must be able to participate fully in the informed consent process

Main Exclusion: Clinical history of atherosclerotic disease (prior myocardial infarction, stroke, peripheral artery disease) or any contraindications to MRI, including claustrophobia, any trauma or surgery which may have left magnetic material in the body, magnetic implants or pacemakers, and inability to lie still for 1 hour or more.

Study Participation Length: 2 Visits

Compensation: Yes    

Randomized Controlled Trial of Repeated Dose Intravenous Ketamine for PTSD

PI: Adriana Feder, MD

Study Coordinator: Abigail Collins

Funding: Ichan School of Medicine at Mount Sinai and NARSAD

Description: We are studying whether ketamine, when given repeatedly intravenously (into a vein) can produce a quick and persistent improvement in PTSD symptoms. We are comparing the effects of ketamine with those of midazolam, which has similar acute anesthetic effects compared to ketamine but has not been shown to treat or alleviate any symptoms of PTSD. This makes midazolam an appropriate substance to gauge whether ketamine can treat or alleviate PTSD symptoms thereby acting as what we call an active control.

Main Inclusion: Primary chronic PTSD diagnosis, between 18-65 years old

Main Exclusion: Lifetime history of psychotic features, diagnosis of schizophrenia, diagnosis of bipolar disorder, any clinically significant axis II disorder, current eating disorder, drug or alcohol abuse/dependence within preceding year, serious unstable medical illnesses

Study Participation Length: Approximately 1 –1.5 months

Compensation for all study visits: Yes

Clinicaltrials.gov: NCT02397889 

We have no studies currently recruiting in this area.

We have no studies currently recruiting in this area.