Pharmaco-Neuroimaging Studies of Approach/Avoidance Behaviors and Post-Mortem Studies: Pharmacological Manipulation
Key facts
- Who runs it
- Mclean Hospital
- Where
- Belmont, United StatesSee the site
- Trial code
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 112 people, planned
- Started
- 1 Feb 2025
- Expected to end
- 31 Mar 2027
- Type of study
- Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Nociceptin Receptor Antagonist
- Aversive stimuli
- Record updated
- 18 May 2026
Who can take part
- Age
- 18 years to 45 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 26 criteriaShow less
Who can take part
- 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)
Who cannot take part
- Current use of other psychotropic drugs
- History of seizure disorder or currently on anticonvulsants
- 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 a lifetime history of electroconvulsive therapy
- Failure to meet standard magnetic resonance imaging safety requirements
- Clinical or laboratory evidence of hypothyroidism
- 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
- Patients with mood congruent or mood incongruent psychotic features
- Abnormal ECG and lab results
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 45 years old?
Where in United States
- McLean HospitalBelmont, United StatesContact: Ethan Zhang, BATaking people
About the trial
What the trial wants to find out
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).
The 4 groups in the trial
- Participants with MDD or an anxiety disorder receiving the nociceptin receptor antagonistTreatment being tested
After a diagnostic interview (determining the presence of MDD or an anxiety disorder) and collection of blood for Orphanin FQ/Nociceptin assays, participants will receive the nociceptin receptor antagonist. Participants will then complete an approach/avoidance task. Functional magnetic resonance imagining (fMRI) will begin 2 hours after the nociceptin receptor antagonist is administered.
Treatment: Nociceptin Receptor Antagonist and Aversive stimuli
- Participants with MDD or an anxiety disorder receiving the placeboPlacebo, for comparison
After a diagnostic interview (determining the presence of MDD or an anxiety disorder) and collection of blood for Orphanin FQ/Nociceptin assays, participants will receive the placebo. Participants will then complete an approach/avoidance task. fMRI will begin 2 hours after the placebo is administered.
Treatment: Aversive stimuli
- Healthy controls receiving the nociceptin receptor antagonistTreatment being tested
After a diagnostic interview (determining healthy control status) and collection of blood for Orphanin FQ/Nociceptin assays, participants will receive a nociceptin receptor antagonist. Participants will then complete an approach/avoidance task. fMRI will begin 2 hours after the nociceptin receptor antagonist is administered.
Treatment: Nociceptin Receptor Antagonist and Aversive stimuli
- Healthy controls receiving the placeboPlacebo, for comparison
After a diagnostic interview (determining healthy control status) and collection of blood for Orphanin FQ/Nociceptin assays, participants will receive the placebo. Participants will then complete an approach/avoidance task. fMRI will begin 2 hours after the placebo is administered.
Treatment: Aversive stimuli
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Pharmaco-Neuroimaging Studies of Approach/Avoidance Behaviors and Post-Mortem Studies: Study 1.1. (Pharmacological Manipulation)
- Fit questions
- Built from NCT05232032, who can take part
- Record updated
- 18 May 2026