Actively Recruiting

Age: 18Years - 45Years
All Genders
Healthy Volunteers
NCT05630963

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

Led by Mclean Hospital · Updated on 2025-10-21

228

Participants Needed

1

Research Sites

269 weeks

Total Duration

On this page

Sponsors

M

Mclean Hospital

Lead Sponsor

N

National Institute of Mental Health (NIMH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 45Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • All genders, races, and ethnic origins, aged between 18 and 45
  • Able to provide written informed consent and fluent in English
  • Right-handed
  • No psychotropic medications taken for at least 2 weeks
  • Owns a smartphone (iPhone or Android) for ecological momentary assessment
  • For Remitted MDD group: history of MDD as defined by DSM-5 and no anxiety disorder in past two months
  • For Current MDD group: presence of MDD as defined by DSM-5 and no anxiety disorder in past two months
Not Eligible

You will not qualify if you...

  • Suicidal ideation unsafe for outpatient treatment
  • Pregnant women or women of childbearing potential not using medically accepted contraception
  • Serious or unstable medical illnesses including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic diseases
  • History of seizure disorder
  • Psychiatric illnesses other than depression or anxiety disorders (for Current and Remitted MDD groups)
  • History of substance or alcohol use disorder except mild cases resolved over 12 months ago
  • History of cocaine, stimulant, or dopaminergic drug use
  • Diagnosis of dementia or Mini Mental State Examination score below 26
  • Presence of mood congruent or incongruent psychotic features
  • Current use of other psychotropic drugs
  • Clinical or laboratory hypothyroidism
  • Lifetime history of electroconvulsive therapy
  • Failure to meet MRI safety requirements
  • Abnormal ECG or lab results
  • Contraindications for arterial line placement (e.g., abnormal Allen test, Raynaud's syndrome, anemia, bleeding disorders, fainting from blood draws)

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

McLean Hospital

Belmont, Massachusetts, United States, 02478

Actively Recruiting

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Research Team

T

Tracy Lam, BS

CONTACT

D

David Crowley, ALM

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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Beyond Monoamines: The Role of the Nociceptin/Orphanin FQ Receptor in Major Depression | DecenTrialz