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

Part of paid clinical trials in Belmont, Massachusetts.

Sponsor
Mclean Hospital
Study ID
NCT05630963
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Aversive stimuli — DEVICE
    Electrotactile stimulation will be used as the aversive stimulus. The aversive stimulus is delivered in the form of a mild half-second stimulation to the ankle, calibrated to a subjective threshold that is uncomfortable but not painful. This stimulation is delivered by Digitimer DS8R Constant Current Stimulator (Digitimer North America, LLC. Ft. Lauderdale, FL). Its previous model DS71 has been safely implemented in studies with previously MGH-approved IRB's (Milad et al., 2013).
  • PET radiotracer — DRUG
    A Nociceptin/Orphanin FQ ("N/OFQ") peptide tracer (\[11C\] NOP-1A) will be used as the PET radiotracer. Approximately 10 mCi of this tracer will be delivered intravenously as a slow bolus over 60 seconds with beginning of the PET imaging acquisition. Approximately 60 ml of blood will be drawn from an artery throughout the dynamic PET acquisition in order to measure the blood N/OFQ levels.

Study Details

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.

Key Dates

Start date
Dec 29, 2021
Status verified
Oct 2025
Primary completion
Oct 28, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
228 participants (estimated)

Arms

  • Arm: MDD subjects
    Subjects diagnosed with Major Depression Disorder
  • Arm: Remitted MDD subjects
    Subjects with a history of major depressive disorder episode in the past
  • Arm: Control subjects
    Subjects with no history of known neurological and psychiatric illness.

Primary Outcome Measure

Clinical Interview [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
McLean HospitalBelmontMassachusetts02478
Tracy Lam, BS
[email protected]
617-855-4437

Find similar trials in Belmont, MA

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
McLean Hospital· Belmont, MA

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