Research Center: Collective Medical Research
Location: 7501 College Blvd, Suite 100, Overland Park, KS 66210
Lead Researcher: Dr. Haydn Mikel Thomas, M.D.
IRB: This study has been reviewed and approved by the Advarra Institutional Review Board

Are you or someone you know struggling with Major Depressive Disorder (MDD)? You’re not alone. MDD affects a significant number of Americans, highlighting the urgent need for more effective treatments. At Collective Medical Research, researchers are spearheading a groundbreaking study to explore an alternative approach to treating MDD.
Researchers are seeking individuals who are ready to explore this potential new treatment. By participating, you’ll not only have access to innovative therapies but also play a crucial role in advancing MDD research. Your involvement could lead to discoveries that benefit individuals with MDD in the future. Take the first step towards a brighter future and consider signing up today!

• Participants will receive a new potential treatment for major depressive disorder (MDD) at no cost.
• Participants will be compensated up to $550 for participating in this study. Compensation will only be provided to eligible participants who complete the study.
• Participants may experience improvements in managing symptoms of MDD.
• Participants will be contributing valuable information that may benefit those with MDD 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 18-65 who are diagnosed with Major Depressive Disorder (MDD)
• Must be willing to use highly effective forms of contraception
• Must not be pregnant, breastfeeding, or planning to become pregnant during the study
• Must not regularly use cannabis
• Must be willing to refrain from taking any illegal substances including cannabis during this study
• Must be willing to refrain from drinking alcohol within 8 hours of any study assessment
• Must not have an active alcohol/substance use disorder
• Must not have a history of treatment-resistant depression (defined as 2 or more failed treatments of adequate dose and duration in the current depressive episode)
• Must not be allergic to bupropion, dextromethorphan, or opioid drugs (e.g., codeine)
• Must not have received dextromethorphan co-administered with quinidine (e.g., Nuedexta) within the past 4 weeks
• Must not have had a gastric bypass or have any condition that affects drug absorption
• Must not have narrow-angle glaucoma
• Must not have HIV
• Must not have hepatitis B and/or C infection
• Must not currently be hospitalized or residing in an in-patient facility
• Must not have a history of electroconvulsive therapy, vagus nerve stimulation, transcranial magnetic stimulation, or any experimental central nervous system treatment within the last 6 months
• Must not have started any psychotherapy, phototherapy, or other non-drug therapies within the past 3 months
• Must not have participated in 2 or more clinical trials within the past year
• Must not be an employee of the study site or have an immediate family member who is involved in this study
• Must not have a history of kidney disease
• Must not have a history of cardiovascular disease or any significant cardiovascular condition
• Must not have a known clinically significant cerebrovascular disease
• Must not have prior exposure to soltiamfetol/Sunosi through either a clinical study or prescription
• Must not have a history of severe drug allergy or hypersensitivity
• Must not have a history of phenylketonuria or history of hypersensitivity to phenylalanine-derived products
• Must be able to attend 9 study visits over approximately 7 weeks. This will include 7 on site clinic visits and 2 remote visits. Clinic visits are expected to last approximately 3 hours; however, the first visit may be longer. Remote visits are expected to last no more than 30 minutes and may occur via video or phone call.

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

• Participants will be asked to read this informed consent form and ask as many questions as needed, follow the instructions of the study doctor and study staff, and provide the study doctor with a complete and true history of illnesses, medications (including prescriptions, over-the-counter drugs, vitamins, or dietary/herbal supplements)
• Participants will be asked to take the study medication as instructed
• Participants will be asked to complete the DAMS diary every day and to be honest with the study doctor about how they are feeling. Some important things for the participant to do include:
  • Keeping the study drug in a safe place, away from children, and for their use only
  • Return any unused study drug as well as the bottles, even if empty, at each visit
  • Bring the VAMS diary to each in-person visit to the clinic
  • Report any lost or missed study drug tablets
  • Keep study appointments. If an appointment must be missed, please contact the study doctor, or study staff to reschedule
  • Tell the study doctor or study staff about any doctor’s visits or hospitalizations that may have as well as any pre-planned procedures
  • Refrain from donating blood while you are taking part in the study
  • You may not participate or enroll in any other study until this study is over. You may only participate in this study at this location. Your participation in this study will immediately end if you enroll in another study.

Collective Medical Research
Together with our community, Collective Medical Research has been advancing healthcare in Kansas City for 30 years. Get early access to new and emerging drugs, find out more about your condition, contribute to advancement in medicine, and help other patients!

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.