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

StatusRecruiting
PhasePhase 2
Started2025-02-01
View on ClinicalTrials.gov ↗

Amendment history

2026-05-15
Study Status v11
Primary completion date2026-03-31→2027-03-31
Completion date2026-03-31→2027-03-31
2025-12-17
Study Status v10
Primary completion date2025-12-31→2026-03-31
Completion date2025-12-31→2026-03-31
2025-11-05
Study Status, Oversight, Contacts/Locations v9
Study sitescontacts updated at 1 of 1 site
2025-10-17
Not Yet Recruiting→Recruiting Study Identification, Study Status, Contacts/Locations v8
Trial statusNot Yet Recruiting→Recruiting
Study sites0→1
2025-01-13
Study Status, Oversight v7
Primary completion date2025-03-31→2025-12-31
Completion date2025-03-31→2025-12-31
Start date2024-08-01→2025-02-01
Show 6 earlier versions
2024-05-09
Study Status v6
Start date2024-04-01→2024-08-01
2024-03-11
Study Status, Contacts/Locations v5
Re-verified, no change to tracked fields
2024-01-09
Study Status v4
Start date2023-07-01→2024-04-01
2023-03-13
Study Identification, Study Status v3
Start date2022-12-01→2023-07-01
Study title-13 characters
Pharmaco-Neuroimaging Studies of Approach/Avoidance Behaviors and Post-Mortem Studies: Study 1.1. (Pharmacological Manipulation)
2022-11-03
Study Status, Sponsor/Collaborators v2
Start date2022-09-01→2022-12-01
2022-04-14
Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility v1
Eligibility criteria+65 characters
[...] ic Disorder, Post Traumatic Stress (diagnosed using the SCID-5) Written informed consent For MDD subjects, a baseline HRSDHamilton Depression Rating Scale score (Hamilton 1960) > 16 (17-item version) Right-handed Has a smartphone (iPhon [...] nd a structured clinical interview (diagnosed using the SCID-5) Written informed consent Right-handed Absence of any medic [...] chotic disorders not otherwise specified, bipolar disorder, OCDobsessive-compulsive disorder, patients with mood congruent or mood incongruent psychotic [...] story of electroconvulsive therapy Failure to meet standard MRImagnetic resonance imaging [...]
Secondary endpoints10 entries, revised
Temporal Experience of PleasePleasure Scale Life Events and DifficultyDifficulties ScaleSchedule Longitudinal Interval Follow-Up Evaluation (LIFE) (Keller et al., 1987)
Primary endpoints4 entries, revised
AproachApproach/Avoidance Task MRIMagnetic DataResonance Imagining Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (SCID-5)
2022-02-01
Original filing
Mclean Hospital
53 trials monitored
See 1 trial at risk
Depression
2,976 trials monitored
See 162 trials at risk
Anxiety
2,229 trials monitored
See 91 trials at risk
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).
Trial Details
NCT Number NCT05232032
Lead Sponsor Mclean Hospital
Collaborators: National Institute of Mental Health (NIMH), Massachusetts General Hospital, Massachusetts Institute of Technology, University of Washington, Brown University
Conditions Depressive Disorder, Major, Anxiety Disorder
Enrollment 112 participants
Start Date 2025-02-01
Primary Completion 2027-03-31 (estimated)
Study Completion 2027-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-18