Pharmaco-Neuroimaging Studies of Approach/Avoidance Behaviors and Post-Mortem Studies: Pharmacological Manipulation
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-45
SponsorMclean Hospital
About this trial
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).
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Nociceptin Receptor Antagonist
- Aversive stimuli
Treatment groups
112 Participants
are divided into 4 treatment groupsSponsors and collaborators
Mclean Hospital
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Massachusetts General Hospital
Collaborator
Massachusetts Institute of Technology
Collaborator
University of Washington
Collaborator
Brown University
Collaborator
Source ClinicalTrials.gov