Status:
RECRUITING
Pharmaco-Neuroimaging Studies of Approach/Avoidance Behaviors and Post-Mortem Studies: Pharmacological Manipulation
Lead Sponsor:
Mclean Hospital
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Massachusetts General Hospital
Conditions:
Depressive Disorder, Major
Anxiety Disorder
Eligibility:
All Genders
18-45 years
Phase:
PHASE2
Brief Summary
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 depressiv...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT05232032
Start Date
February 1 2025
End Date
March 31 2026
Last Update
December 18 2025
Active Locations (1)
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1
Mclean Hospital
Belmont, Massachusetts, United States, 02478