Who is eligible for clinical trial NCT05630963?

Participants must meet the protocol's inclusion criteria for Major Depressive Disorder. The stated age range is 18 Years to 45 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT05630963 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

Beyond Monoamines: The Role of the Nociceptin/Orphanin FQ Receptor in Major Depression (NCT05630963)

🟢 Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: Mclean Hospital

🩺 Plain-English Summary (8th-Grade Level)

This study looks at the role of the Nociceptin/Orphanin FQ receptor system in the brain of individuals with current or past major depressive disorder (MDD). It also examines how individuals with a history of depression make certain decisions and which brain regions are involved in such decisions. Information collected through MRI, PET, biospecimens (i.e., blood, saliva) and behavioral tasks will be used to predict depressive symptoms in the future.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (12 items) and avoid the listed exclusions (17 items).

Location: McLean Hospital — Belmont, Massachusetts

Age range: 18 Years to 45 Years

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

Exclusion Criteria for all participants:
Subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician. These patients will be immediately referred to appropriate clinical treatment
Pregnant women or women of childbearing potential who are not using a medically accepted means of contraception (defined as oral contraceptive pill or implant, condom, diaphragm, spermicide, IUD, s/p tubal ligation, or partner with vasectomy)
Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease
History of seizure disorder
History of psychiatric illnesses, other than depression or anxiety disorders among the Current MDD and Remitted MDD groups
History of substance use disorder or alcohol use disorder (as these terms are defined by DSM-5); except depressed subjects may have a history of 'Mild' substance/alcohol use disorder only if it ended as least 12 months ago
History of cocaine or stimulant use or dopaminergic drugs
History or current diagnosis of dementia, or a score of \< 26 on the Mini Mental State Examination at the screening visit;
Patients with mood congruent or mood incongruent psychotic features
Current use of other psychotropic drugs
Clinical or laboratory evidence of hypothyroidism

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

McLean Hospital — Belmont, Massachusetts

📞 Contact the Study Coordinator

Phone: (617) 855-4437

Email: mclrew41study@mgb.org

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗