Pharmaco-Neuroimaging Studies of Approach/Avoidance Behaviors and Post-Mortem Studies: Study 1.1. (Pharmacological Manipulation)
Overview
- Phase
- Phase 2
- Intervention
- Nociceptin Receptor Antagonist
- Conditions
- Depressive Disorder, Major
- Sponsor
- Mclean Hospital
- Enrollment
- 112
- Locations
- 1
- Primary Endpoint
- Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (SCID-5)
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
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 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).
Investigators
Diego Pizzagalli
Professor, Department of Psychiatry, Harvard Medical School, McLean Hospital, McLean Hospital
Mclean Hospital
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Participants with MDD or an anxiety disorder receiving the nociceptin receptor antagonist
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.
Intervention: Nociceptin Receptor Antagonist
Participants with MDD or an anxiety disorder receiving the nociceptin receptor antagonist
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.
Intervention: Aversive stimuli
Participants with MDD or an anxiety disorder receiving the placebo
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.
Intervention: Aversive stimuli
Healthy controls receiving the nociceptin receptor antagonist
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.
Intervention: Nociceptin Receptor Antagonist
Healthy controls receiving the nociceptin receptor antagonist
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.
Intervention: Aversive stimuli
Healthy controls receiving the placebo
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.
Intervention: Aversive stimuli
Outcomes
Primary Outcomes
Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (SCID-5)
Time Frame: Baseline
Diagnostic assessment
Magnetic Resonance Imagining
Time Frame: Within 30 days of the clinical interview
Both structural and functional brain images
Approach/Avoidance Task
Time Frame: During the MRI scan
A novel behavioral task assessing approach/avoidance decision-making
Orphanin FQ/Nociceptin assays (using blood samples)
Time Frame: On the day of the MRI scan
Measure of Orphanin FQ/Nociceptin
Secondary Outcomes
- Perceived Stress Scale(Baseline, 6-month follow-up, 12-month follow-up)
- Medical Outcome Survey- Short Form(Baseline, 6-month follow-up, 12-month follow-up)
- Snaith Hamilton Pleasure Scale(Baseline, 6-month follow-up, 12-month follow-up)
- Hamilton Rating Scale for Depression(Baseline, 6-month follow-up, 12-month follow-up)
- Beck Depression Inventory-II(Baseline, 6-month follow-up, 12-month follow-up)
- Quality of Life Enjoyment and Satisfaction Questionnaire(Baseline, 6-month follow-up, 12-month follow-up)
- Temporal Experience of Pleasure Scale(Baseline, 6-month follow-up, 12-month follow-up)
- Life Events and Difficulties Schedule(Baseline, 6-month follow-up, 12-month follow-up)
- Longitudinal Interval Follow-Up Evaluation (LIFE) (Keller et al., 1987)(6-month follow-up, 12-month follow-up)
- Columbia-Suicide Severity Rating Scale(Baseline, 6-month follow-up, 12-month follow-up)