Pharmaco-Neuroimaging Studies of Approach/Avoidance Behaviors and Post-Mortem Studies: Pharmacological Manipulation
- Conditions
- Anxiety DisorderDepressive Disorder, Major
- Interventions
- Drug: Nociceptin Receptor AntagonistDevice: Aversive stimuli
- Registration Number
- NCT05232032
- Lead Sponsor
- Mclean Hospital
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 112
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Participants with MDD or an anxiety disorder receiving the nociceptin receptor antagonist 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. Participants with MDD or an anxiety disorder receiving the nociceptin receptor antagonist Aversive stimuli 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. Participants with MDD or an anxiety disorder receiving the placebo Aversive stimuli 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. Healthy controls receiving the nociceptin receptor antagonist 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. Healthy controls receiving the nociceptin receptor antagonist Aversive stimuli 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. Healthy controls receiving the placebo Aversive stimuli 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.
- Primary Outcome Measures
Name Time Method Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (SCID-5) Baseline Diagnostic assessment
Magnetic Resonance Imagining Within 30 days of the clinical interview Both structural and functional brain images
Approach/Avoidance Task During the MRI scan A novel behavioral task assessing approach/avoidance decision-making
Orphanin FQ/Nociceptin assays (using blood samples) On the day of the MRI scan Measure of Orphanin FQ/Nociceptin
- Secondary Outcome Measures
Name Time Method Perceived Stress Scale Baseline, 6-month follow-up, 12-month follow-up 14-item measure of stress appraisal; scores range from 0 to 56; higher scores indicate higher perceived stress
Medical Outcome Survey- Short Form Baseline, 6-month follow-up, 12-month follow-up 36-item measure of physical and social functioning; score range from 36 to 149; higher scores indicate higher physical and social functioning
Snaith Hamilton Pleasure Scale Baseline, 6-month follow-up, 12-month follow-up 14-item measure of anhedonia; scores range from 14 to 56; higher scores indicate higher anhedonia
Hamilton Rating Scale for Depression Baseline, 6-month follow-up, 12-month follow-up 17-item measure of depression severity; scores range from 0 to 34; higher scores indicate higher depression severity
Beck Depression Inventory-II Baseline, 6-month follow-up, 12-month follow-up 21-item measure of depression severity; scores range from 0 to 63; higher scores indicate higher depression severity
Quality of Life Enjoyment and Satisfaction Questionnaire Baseline, 6-month follow-up, 12-month follow-up 16-item measure of satisfaction and enjoyment across domains (e.g., work, interpersonal); scores range from 16 to 80; higher scores indicate higher life enjoyment and satisfaction
Temporal Experience of Pleasure Scale Baseline, 6-month follow-up, 12-month follow-up 24-item measure of anticipatory and consummatory pleasure; scores range from 24 to 144; higher scores indicate higher anticipatory/consummatory pleasure
Life Events and Difficulties Schedule Baseline, 6-month follow-up, 12-month follow-up Measure of acute events, difficulties, stressors
Longitudinal Interval Follow-Up Evaluation (LIFE) (Keller et al., 1987) 6-month follow-up, 12-month follow-up Retrospectively assesses different DSM-5 disorders, social and occupational functioning, and life satisfaction over the past 6 months
Columbia-Suicide Severity Rating Scale Baseline, 6-month follow-up, 12-month follow-up Suicide assessment