Research Center: Icahn School of Medicine at Mount Sinai
Location: 1399 Park Avenue, New York, New York, 10029-6574, United States
Lead Researcher: James Murrough, M.D., Ph.D.
IRB: This study has been reviewed and approved by the Icahn School of Medicine at Mount Sinai Institutional Review Board

Major Depressive Disorder (MDD) is one of the most disabling mental health conditions worldwide, with the usual antidepressants proving not as effective for many people with this condition. Researchers at Icahn School of Medicine at Mount Sinai are conducting a new potential research study in New York. This study will allow researchers to better understand the role that anti-inflammatories could have as a potential approach to treatment-resistant depression.

The results of this study could potentially improve symptoms of depression, such as anhedonia, by reducing inflammation in the body. Inflammation has been shown to be elevated in people with MDD. This study could potentially help create a new treatment option for those who are struggling to manage symptoms of treatment-resistant depression.

If you suffer from depression and find that current treatments don’t work for you, then consider joining this research study!

• Participants may experience potential improvement in their MDD symptoms.
• Participants will provide researchers with information that could help develop treatments for depressive disorders in the future.
• Participants will be compensated $600 for participating in this study.
• Participants from bordering states (CT,NJ,PA) will be eligible for a $150 travel reimbursement per visit.
• Participants may experience improvements in the management of symptoms of depression.
• Participants will be contributing valuable information that may benefit those with MDD or treatment-resistant depression in the future.
• Participants will be helping to advance medical 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 18-70 diagnosed with Major Depressive Disorder (MDD) who are currently experiencing a Major Depressive Episode (MDE)
• Must have tried at least 2 antidepressants during their current depressive episode
• If taking antidepressants, the dose must be stable for the past 4 weeks and remain stable throughout the study
• Must not be diagnosed with substance use disorder within the past 6 months, with the exception of nicotine use disorder
• Must not currently be taking biologic medications/treatments or immunosuppressants
• Must not have experienced any conditions that would make receiving MRI scans not possible. Examples would be being claustrophobic, having magnetic implants or pacemakers in the body or being unable to lie still for 1 hour or more
• Must not have a known allergy to gadolinium
• Must be able to attend 5 study visits at the research site and all phone or zoom appointments over approximately 12 weeks.

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

• Participation in the study involves completing clinical Interviews, questionnaires, and having vital signs checked, as well as providing urine samples (to test for pregnancy and illegal drug use) and providing blood draws (a blood sample will be drawn from a vein in one’s arm).
• Participation in this study involves completing MRI scans. Participants will be asked to do two brain scans.
• Participation in this study involves receiving either the study medication or a placebo through an injection. A placebo looks like the study medication but does not have the active ingredients and, therefore, has no intended therapeutic effect.

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. It is the medical school for the Mount Sinai Health System, which includes eight hospital campuses, and has more than 5,000 faculty and nearly 2,000 students, residents, and fellows. Their unwavering pursuit of intellectual exchange, breakthrough research, and multidisciplinary teamwork propels it ever forward in biomedical discoveries and advances. Pursuing ideas that often challenge conventional wisdom to revolutionize the practice of medicine and produce dramatically better outcomes for patients. Making big, bold bets by investing in radical free thinkers and technology at the cutting edge.

Please note:
Due to the COVID-19 pandemic, the researchers would like to assure the participants that ensuring their and the study staff’s safety is of utmost importance. However, there are parts of the study that will be conducted through virtual means (i.e., phone call and Zoom call).