Clinical Trials

MAP at Mount Sinai is currently conducting several research studies in mood and anxiety disorders. All of our participants will receive reimbursement for their time, and all treatment studies are conducted entirely free of charge.

Besides research studies, we are also a tertiary care referral center for patients with the most serious and debilitating forms of depression (called treatment resistant depression). For patients referred to us, we conduct a comprehensive diagnostic evaluation. We have several research protocols for difficult-to-treat depressions.

1. The use of Ketamine in Post-traumatic Stress Disorder
Investigators: Dennis Charney, MD & Adriana Feder, MD

Post-traumatic stress disorder (PTSD) is a debilitating anxiety disorder which can develop after exposure to a traumatic or life-threatening experience, such as military combat, physical or sexual abuse, or natural disasters. It is characterized by intrusive re-experiences of traumatic events, avoidance of situations and stimuli that serve as reminders of these events, and feeling jumpy or easily startled. The aim of this study is to test the effectiveness of a potential new drug for PTSD, ketamine. Ketamine is approved by the FDA as an anesthetic, but it is not approved for the treatment of PTSD. Recent studies have shown that a single ketamine infusion can rapidly reduce depressed mood as well as anxiety in patients with severe depression.

The study period will last for a total of approximately six weeks, including two overnight visits. You may be eligible for this study if you are between the ages of 21 and 55 and have a diagnosis of PTSD.

If you are interested in this study, please contact Julia Morgan at 212-241-7906.

2. Evaluation of the CRF1 Antagonist GSK561679 in Women with Post-traumatic Stress Disorder
Investigators: Dan Iosifescu, MD

Post-traumatic stress disorder (PTSD) is a debilitating anxiety disorder which can develop after exposure to a traumatic or life-threatening experience, such as military combat, physical or sexual abuse, or natural disasters. It is characterized by intrusive re-experiences of traumatic events, avoidance of situations and stimuli that serve as reminders of these events, and feeling jumpy or easily startled. The aim of this study is to test the effectiveness of a potential new drug for PTSD.

The study period will last for a total of approximately eight weeks. You may be eligible for this study if you are a woman between the ages of 21 and 65 and have a diagnosis of PTSD. 

If you are interested in this study, please contact Solara Calderon at 212-241-7910.

3. Continuation Intravenous Ketamine in Major Depressive Disorder
Investigator: James Murrough, MD

The purpose of this study is to test the antidepressant effect of ketamine when given repeatedly over a period of 2 weeks. Ketamine is a Food and Drug Administration (FDA) approved anesthetic. This study will test the efficacy (how well it works) of ketamine in patients with major depressive disorder. The study aims to test a strategy for maintaining ketamine's antidepressant effects over longer time periods. You may be eligible for this study if you are between the ages of 21 and 70 and have a diagnosis of major depressive disorder. 

If you are interested in this study please contact Sarah Pillemer at 212-241-3116.

4. Optimization of IV Ketamine for Treatment Resistant Depression
Investigator: Dan Iosifescu, MD

Existing treatments for major depressive disorder (MDD) generally take weeks to months to exert their maximal benefit. There is an urgent need to develop rapid-acting treatments for MDD. Ketamine, a high-affinity N-methyl-D-aspartate (NMDA) glutamate receptor antagonist, has been used as a standard intravenous (IV) anesthetic agent for many years in both pediatric and adult patients. Beyond its well-established role in anesthesia and pain management, there is emerging evidence that ketamine may have rapid antidepressant properties for patients with severe mood disorders. In this study we are investigating whether ketamine can have an antidepressant effect compared to midazolam.

Midazolam has similar anesthetic effects compared to ketamine but has not been shown to be an antidepressant, and is therefore acting as an active control in this study. The study period will last up to 6 weeks, depending on your response to the study medication. There are two required overnight stays in our General Clinical Research Center as part of this study. You may be eligible to participate if you are between the ages of 21 and 80, have a diagnosis of MDD, and have not responded to treatment with antidepressant medications.

If you are interested in this study please contact Sarah Pillemer at 212-241-3116.

5. A Double-Blind, Paroxetine- and Placebo-Controlled Study of 50 mg/day and 100 mg/day of EB-1010 among Outpatients with Major Depressive Disorder Who have Responded Inadequately to Prior Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin Norepinephrine Reuptake Inhibitors (SNRIs)
Investigator: Dan Iosifescu, MD

The purpose of this study is to test how safe, effective and tolerable an experimental drug called EB-1010 is in patients with major depression. “Experimental” means that the drug has not been approved by the United States Food and Drug Administration (FDA). In this study, EB-1010 will be compared to placebo, a substance that looks like the study drug but has no active ingredients, and to paroxetine, an FDA approved drug to treat patients with major depression.

You may qualify to take part in this research study because you are an adult (between the ages of 18 and 65) with major depressive disorder who has not had a satisfactory response from your current antidepressant treatment. Your participation in this research study is expected to last up to 17 weeks and will require 15 visits to our facility.

If you are interested in this study please contact Sarah Pillemer at 212 241-3116.

6. Treatment of Cognitive Dysfunction in Bipolar Disorder
Investigator: Dan Iosifescu, MD

Patients with bipolar disorders frequently experience significant deficits in attention, memory and executive planning, even when their mood symptoms (depression or mania) are under control. Such cognitive impairment is associated with psychosocial and vocational functional deficits, such as decreased ability to perform at work. Despite its importance, no validated treatments exist for cognitive impairments in bipolar disorder. In this study we will assess the efficacy and safety of galantamine (a medication approved for Alzheimer’s disease) for the treatment of functional and cognitive impairments in bipolar disorder. Before the onset of medication treatment and at the end of the study we will administer a battery of neuropsychological tests.

The study period will last four months, including outpatient six visits. You may be eligible for this study if you are between the ages of 18 and 65 and have a diagnosis of bipolar disorder, have experienced minimal or no depression or mania in the last three months and suffer from attention memory or executive planning difficulties.

If you are interested in this study, please contact Rosa Pasculli at 212-241-3089.

7. A Functional Magnetic Resonance Imaging Investigation of Ketamine in Treatment-Resistant Major Depression
Investigator: James Murrough, MD

Major Depressive Disorder (MDD) is a common, disabling illness that leads to considerable morbidity and mortality. However, currently available biological therapies for this disorder have only limited efficacy and neural mechanisms that contribute to the pathophysiology of MDD remain unclear. Functional neuroimaging is emerging as an important method for investigating potential dysfunction in neural systems that underlie MDD and other neuropsychiatric conditions. Further, functional neuroimaging can be combined with pharmacological interventions to aim in the elucidation of neural mechanisms of drug action, the identification of potential biomarkers for illness and treatment response, and for novel drug discovery.

The current study will investigate the antidepressant mechanism of action of ketamine therapy in patients with treatment-resistant major depression (TRD) using an emotional activation blood oxygenation level-dependent (BOLD) functional magnetic resonance imaging (fMRI) paradigm. Ketamine is an N-methyl-D-aspartate (NMDA) glutamate receptor antagonist that has demonstrated rapid-acting antidepressant properties in patients after a single intravenous (IV) infusion. The antidepressant effects of ketamine are apparent within four hours of infusion, peak about 24 hours post-infusion, and persist for several days or in some cases several weeks. The neurobiological mechanisms of the antidepressant effects of ketamine are unknown and represent a critical area of potential research in the pathophysiology and treatment of major depression.

You may be eligible to participate in this MRI study if you are enrolled in a ketamine clinical trial at Mount Sinai. You may also be eligible to participate in you have a primary diagnosis of major depression and are not currently taking any antidepressant medication. Alternatively, this study is recruiting healthy volunteer participants who do not have medical or psychiatric disorders.

If you are interested in this study, please contact James Murrough at 212-241-7574.


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Atran Berg Laboratory Building
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