Research Center: Henry Ford Health System
Location: Michigan, 48377, United States
Lead Researcher: Dr. Christopher Drake
IRB: This study has been reviewed and approved by Henry Ford Health IRB and Advarra.

Life doesn’t stop when a medical diagnosis happens, but sometimes your emotional strength feels like it does. If stress, anxiety, or depression tied to your condition has been growing heavier, you’re not alone. That struggle is real, and it matters.

Henry Ford Health System is running a research study evaluating whether a potential treatment can help lift mood and ease emotional distress in people living with cancer, Parkinson’s disease, ALS, MS, or IPF. This research could offer new hope for those struggling to feel like themselves again. Participants may receive up to $1,250 for joining.

Take a step toward emotional healing while helping advance important medical research. See if this study is right for you.

• Receive the investigational study drug RE104 or a comparison dose at no cost, along with all study-related tests and visits.
• Earn up to $1,250 for completing study visits, plus mileage and travel reimbursement for in-person visits.
• While results can vary, some participants may experience reduced depression or anxiety related to their medical condition.
• Help researchers better understand emotional challenges linked to cancer, ALS, MS, Parkinson’s disease, or IPF and shape future treatment options.
• Be part of advancing medical research at Henry Ford Health System, contributing to care that may benefit others in the future.

• You will receive a detailed outline of all details of the study, including treatment, risks, and procedures, and you will be given the chance to ask study staff questions before you decide whether to participate.
• 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
• Your records relating to this study and any other information received will be kept strictly confidential, except as required by law.

Who Can Participate:

• Must be willing and able to travel to the research site in Novi, Michigan? Travel and hotel accommodations may be provided.
• Be between 18 and 80 years old
• Be experiencing depression, or both depression and anxiety, as a response to coping with a medical condition or a recent change in their health (often referred to as adjustment disorder)
• Have emotional symptoms related to one of the following medical conditions:
  • Cancer (any stage)
  • ALS (Lou Gehrig’s disease)
  • MS (relapsing–remitting multiple sclerosis)
  • Parkinson’s disease
  • Idiopathic pulmonary fibrosis (IPF)
• Have been experiencing these symptoms for at least 4 weeks
• Be expected, based on current health status, to live at least 6 more months
• Be able to walk and take care of their basic daily needs independently
• Be willing to wait before starting any new depression or anxiety treatments during the study period
• Have an adult (family member, caregiver, or trusted friend) available to accompany them home after the dosing session
• Be willing and able to complete all required study visits and procedures over a period of up to 70 days

Who Cannot Participate:

• A history of cancer in the brain or spinal cord, or an active disease affecting these areas
• A current or previous diagnosis of:
  • Bipolar disorder
  • Schizophrenia
  • Schizoaffective disorder
  • Psychosis or hallucinations
  • Borderline personality disorder
  • Or having a parent, sibling, or child with bipolar disorder or psychosis
• A medical condition that could interfere with safe participation, such as:
  • A neurologic disorder not listed in the “Who Can
  • Participate” section
  • Uncontrolled diabetes
  • Epilepsy or a history of seizures (except childhood febrile seizures)
  • Severe heart disease
  • Severe liver failure
  • Severe kidney failure
• Currently pregnant or breastfeeding
• Participation in another clinical trial within the past 30 days

Henry Ford Health System
Henry Ford Health is one of the nation’s leading academic medical centers, recognized for clinical excellence in cancer care, cardiology and cardiovascular surgery, neurology and neurosurgery, orthopedics and sports medicine, and multi-organ transplants. Consistently ranked among the top five NIH-funded institutions in Michigan, Henry Ford Health engages in more than 2,000 research projects annually. Equally committed to educating the next generation of health professionals, Henry Ford Health trains more than 4,000 medical students, residents, and fellows every year across 50+ accredited programs.

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

• Participants will complete screening steps to confirm eligibility, including interviews and questionnaires about medical history, mental health, medications, symptoms, and overall well-being, along with routine checks like height/weight, blood and urine tests, pregnancy testing (if applicable), ECG, and lung function tests.
• Participants will receive one dosing session of the study drug (RE104 or a comparison dose) at the clinic, followed by monitoring during the session and support from the study team. Some sessions may include audio or video recording for research purposes.
• Participants will attend follow-up visits for up to 70 days (about 9 total visits, with some by phone or telehealth) to check on mood, safety, and any changes in symptoms, helping researchers understand how the treatment works over time.