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Pharmaco-Neuroimaging Studies of Approach/Avoidance Behaviors and Post-Mortem Studies: Pharmacological Manipulation

Mclean Hospital · with National Institute of Mental Health (NIMH), Massachusetts General Hospital · NCT05232032

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–45 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 2
Target enrollment
112
US sites recruiting
1
Study start
February 1, 2025
Record last updated
May 18, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

The study will investigate whether a nociceptin receptor antagonist will normalize neural and behavioral processes of approach/avoidance decision-making in unmedicated individuals with major depressive disorder (MDD) and anxiety disorders. More specifically, the study aims to investigate dysregulation within (1) corticostriatal-midbrain circuitry and (2) nociceptin/orphanin FQ peptide and the nociceptin receptor (NOPR).

Being studied: Nociceptin Receptor Antagonist; Aversive stimuli

Conditions: Depressive Disorder, Major; Anxiety Disorder

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion criteria for MDD/anxiety disorder group:

  • DSM-5 diagnostic criteria for MDD, Generalized Anxiety Disorder, Social Phobia, Panic Disorder, Post Traumatic Stress (diagnosed using the SCID-5)
  • Written informed consent
  • For MDD subjects, a baseline Hamilton Depression Rating Scale score > 16 (17-item version)
  • Right-handed
  • Has a smartphone (iPhone or Android) (needed for Ecological Momentary Assessment)
  • Absence of any psychotropic medications for at least 2 weeks (6 weeks for fluoxetine, 6 months for neuroleptics, 2 weeks for benzodiazepines, 2 weeks for any other antidepressants)

Inclusion criteria for healthy controls

  • Absence of medical, neurological, and psychiatric illness (including alcohol and substance abuse), as assessed by subject history and a structured clinical interview (diagnosed using the SCID-5)
  • Written informed consent
  • Right-handed
  • Absence of any medications for at least 3 weeks
  • Has a smartphone (iPhone or Android) (needed for Ecological Momentary Assessment)

Exclusion criteria for all participants

  • Subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician
  • Pregnant women or women of childbearing potential who are not using a medically accepted means of contraception
  • Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease
  • History of seizure disorder
  • History or current diagnosis of any of the following DSM-IV psychiatric illnesses: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, obsessive-compulsive disorder, patients with mood congruent or mood incongruent psychotic features, substance dependence, substance abuse within the last 12 months (with the exception of cocaine or stimulant abuse; which will lead to exclusion)
  • History of cocaine or stimulant use (e.g., amphetamine, cocaine, methamphetamine)
  • History of use of dopaminergic drugs (including methylphenidate)
  • History or current diagnosis of dementia
  • 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
  • Failure to meet standard magnetic resonance imaging safety requirements
  • Abnormal ECG and lab results
  • History of seizure disorder or currently on anticonvulsants

Recruiting US locations

  • Mclean Hospital

    Belmont, MA 02478

    Site contact: Ethan Zhang, BA · 617-855-4434 · ezhang24@mclean.harvard.edu

Study contacts (from the official record)

  • Ethan M Zhang, BA · 617-855-4434 · ezhang24@mclean.harvard.edu
  • David Crowley, ALM · 617-855-4432 · djcrowley@mclean.harvard.edu
All mental health studies in Massachusetts →
Pharmaco-Neuroimaging Studies of Approach/Avoidance Behaviors and… (NCT05232032) | Bored Studies