Recruiting

Nociceptin/Orphanin FQ Receptor

Sponsor:

Mclean Hospital

Code:

NCT05630963

Conditions

Major Depressive Disorder

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Aversive stimuli

PET radiotracer

Study Details

Brief summary:

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

Major Depressive Disorder

Study ID

NCT05630963

Start date

Dec 29, 2021

Status verified date

Oct, 2025

Completion date

Feb 28, 2027

Anticipated

Primary completion date

Oct 28, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Inclusion Criteria for all participants:

  • All genders, races, and ethnic origins, aged between 18 and 45
  • Capable of providing written informed consent, and fluent in English
  • Right-handed
  • Absence of any psychotropic medications for at least 2 weeks
  • Has a smartphone (iPhone or Android) (needed for Ecological Momentary Assessment)

Inclusion Criteria for "Remitted MDD" group:

  • Meets inclusion criteria for all subjects, plus:
  • History of MDD as defined by DSM-5
  • Absence of anxiety disorder for the past two months

Inclusion Criteria for "Current MDD" group:

  • Meets inclusion criteria for all subjects, plus:
  • Presence of MDD as defined by DSM-5
  • Absence of anxiety disorder for the past two months

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
  • Patients with a lifetime history of electroconvulsive therapy (ECT)
  • Failure to meet standard MRI safety requirements
  • Abnormal ECG and lab results
  • History of seizure disorder
  • Contraindications for arterial line (e.g., abnormal result on Allen test, Raynaud's syndrome, history of anemia or bleeding disorder, history of fainting from blood draws).

Study Design

Enrollment

228 participants

Anticipated

Interventions and Outcome Measures

Arms

MDD subjects

Subjects diagnosed with Major Depression Disorder

Remitted MDD subjects

Subjects with a history of major depressive disorder episode in the past

Control subjects

Subjects with no history of known neurological and psychiatric illness.

Interventions

Aversive stimuli

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

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.

Primary outcome measure

  • Clinical Interview [ Time Frame: Baseline ]
  • Behavioral Performance on the Probabilistic Reward Task (PRT) [ Time Frame: Baseline ]
  • MRI Data [ Time Frame: within 30 days of Screening Visit ]
  • Salivary Cortisol [ Time Frame: Baseline ]
  • PET Data [ Time Frame: within 30 days of Screening Visit ]
  • Arterial blood data [ Time Frame: Baseline ]
  • Follow-up Clinical Interviews [ Time Frame: Change from Baseline at 6 months and 12 months after the PET visit ]

Central Contacts and Locations

Locations

McLean Hospital

Recruiting

Belmont, Massachusetts, United States, 02478

Contacts

More Information

Sponsor

Mclean Hospital

Last update posted

Oct 21, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mclean Hospital on 2025-10-21.