Research Center: Icahn School of Medicine at Mount Sinai
Location: 1399 Park Ave, New York, NY 10029, United States
Lead Researcher: James Murrough, MD, PhD
IRB Committee: This study has been reviewed and approved by the Program for the Protection of Human Subjects Institutional Review Board

Struggling with depression? According to the World Health Organization, more than 264 million people worldwide are affected by this condition. It’s more than just feeling sad, and often, not a single treatment can effectively reduce its symptoms.

Researchers from the Icahn School of Medicine want to help those with treatment-resistant depression (TRD). This study seeks to evaluate the effectiveness of a medication for treating depression in people whose symptoms have not responded to two prior treatments. If this research study is successful, it may increase individuals’ quality of life and help ease their depression symptoms.

• Participants will receive a new potential treatment for depression at no cost.
• Participants may experience improvements in their depression symptoms and quality of life. 
• Participants will be contributing valuable information that may benefit those with depression in the future.
• Participants will be compensated up to $1,135 for participating in this study. Compensation will only be provided to eligible participants who complete the study.
• Participants will be helping to advance mental health research.

• If you decide to participate in the study and later feel that you no longer wish to be part of it, you can withdraw at any time.
• Any information that you provide will be kept strictly confidential, except as required by law.
• Qualified health professionals will monitor your health as it relates to the study.

• Men and women aged 21-50 who have been diagnosed with Major Depressive Disorder (MDD).
• Must have failed two courses of antidepressant medication treatment
• Must not have any psychotic or psychiatric conditions.
• Must not have been diagnosed with alcohol or substance use disorder.
• Must be able to attend 13 study visits that consist of an 8-week medication trial and remote and in-house study visits for over approximately 3 months. The in-person study visits would only be about 5.

The study team can explain the research study in its entirety but some study details are:

• The medication used in this study will be in the form of a thrice-a-day pill.
  • This medication has been approved to treat depression in Europe, Asia, and South America, but has not been approved for use by the Food and Drug Administration (FDA). t
• Participants will be asked to complete questionnaires on the severity of their depression. They will also be asked to complete weekly scales with a study coordinator and clinician.
• Participants will be asked to undergo MRI scans. MRI visits will take place at the New York State Psychiatric Institute (NYSPI).
  • Participants will be provided with transportation to take them to and from the scanning visit at NYSPI.
• Participants will be asked to donate a small amount of blood.

Icahn School of Medicine at Mount Sinai

The Icahn School of Medicine at Mount Sinai is an international leader in medical and scientific training, biomedical research, and patient care. Their unwavering pursuit of intellectual exchange, breakthrough research, and multidisciplinary teamwork propel them ever forward in biomedical discoveries and advances. They pursue ideas that often challenge conventional wisdom to revolutionize the practice of medicine and produce dramatically better outcomes for patients. They make big, bold bets by investing in radical free thinkers and technology at the cutting edge.

Please note:
Due to the current situation with the COVID-19 pandemic, the researchers would like to assure the participants that ensuring the safety of the participants as well as the study staff is of utmost importance.