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Nociceptin Receptor Antagonist for Depression and Anxiety

This study is looking at how a medication called a nociceptin receptor antagonist might help people with major depressive disorder (MDD) and anxiety disorders. Researchers want to see if this drug can help normalize how your brain and behavior respond to situations where you have to decide to approach or avoid something. You might be eligible if you are between 18 and 45 years old, have a diagnosis of MDD or certain anxiety disorders, and have a Hamilton Depression Rating Scale score above 16. The study involves receiving 40 mg of the nociceptin receptor antagonist and undergoing an MRI scan while performing a task that uses mild electrical stimulation on your ankle. The current status of this study is unclear, but it plans to enroll 112 participants.

Study design
This is an interventional study planning to enroll 112 participants. It is not specified if it is randomized or blinded, and the phase is not specified.
What's involved
You would undergo a clinical interview, receive 40 mg of the nociceptin receptor antagonist, and have an MRI scan while performing an approach/avoidance task with mild electrical stimulation to your ankle.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured at baseline, within 30 days of the clinical interview, and during the MRI scan. It is not specified if there is follow-up after these measurements.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05232032

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

Recruiting
PHASE2Ages 18–45InterventionalBasic science
Mclean Hospital
~112 participants
Updated 2026-05-18 on ClinicalTrials.gov
What's tested:Nociceptin Receptor AntagonistAversive stimuli

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (SCID-5)
Measured over Baseline
+3 more outcomes measured

Conditions

Depressive Disorder, Major
Anxiety Disorder

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NCT05232032

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Mclean Hospital

    Belmont, Massachusettsstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Diego Pizzagalli, Ph.D. · PRINCIPAL_INVESTIGATOR · Mclean Hospital

Who to contact

Ethan M Zhang, BA
[email protected]
617-855-4434
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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)
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

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

What this trial measures

  • Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (SCID-5)Baseline

    Diagnostic assessment

  • Magnetic Resonance ImaginingWithin 30 days of the clinical interview

    Both structural and functional brain images

  • Approach/Avoidance TaskDuring the MRI scan

    A novel behavioral task assessing approach/avoidance decision-making

  • Orphanin FQ/Nociceptin assays (using blood samples)On the day of the MRI scan

    Measure of Orphanin FQ/Nociceptin