Actively Recruiting
Pharmaco-Neuroimaging Studies of Approach/Avoidance Behaviors and Post-Mortem Studies: Pharmacological Manipulation
Led by Mclean Hospital · Updated on 2025-12-18
112
Participants Needed
1
Research Sites
60 weeks
Total Duration
On this page
Sponsors
M
Mclean Hospital
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial 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).
CONDITIONS
Official Title
Pharmaco-Neuroimaging Studies of Approach/Avoidance Behaviors and Post-Mortem Studies: Pharmacological Manipulation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meets DSM-5 criteria for MDD, Generalized Anxiety Disorder, Social Phobia, Panic Disorder, or Post Traumatic Stress as diagnosed by SCID-5
- Provides written informed consent
- For MDD participants, baseline Hamilton Depression Rating Scale score greater than 16 (17-item version)
- Right-handed
- Owns a smartphone (iPhone or Android) for Ecological Momentary Assessment
- No psychotropic medications for at least 2 weeks (6 weeks for fluoxetine, 6 months for neuroleptics, 2 weeks for benzodiazepines and other antidepressants)
- For healthy controls: no medical, neurological, or psychiatric illness including substance or alcohol abuse
- Healthy controls must provide written informed consent
- Healthy controls must be right-handed
- Healthy controls must have no medications for at least 3 weeks
- Healthy controls must own a smartphone (iPhone or Android)
You will not qualify if you...
- Suicidal ideation deemed unsafe for outpatient treatment by study clinician
- Pregnant women or women of childbearing potential not using medically accepted contraception
- Serious or unstable medical illnesses including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic diseases
- History of seizure disorder or currently taking anticonvulsants
- History or current diagnosis of organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, obsessive-compulsive disorder, mood congruent or incongruent psychotic features
- Substance dependence or abuse within last 12 months, except cocaine or stimulant abuse (which leads to exclusion)
- History of cocaine or stimulant use (amphetamine, cocaine, methamphetamine)
- History of dopaminergic drug use including methylphenidate
- History or current diagnosis of dementia
- Current use of other psychotropic drugs
- Clinical or laboratory evidence of hypothyroidism
- Lifetime history of electroconvulsive therapy
- Failure to meet MRI safety requirements
- Abnormal ECG or laboratory results
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Mclean Hospital
Belmont, Massachusetts, United States, 02478
Actively Recruiting
Research Team
E
Ethan M Zhang, BA
CONTACT
D
David Crowley, ALM
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
4
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