Mclean Hospital
Belmont, Massachusetts, 02478, United States
Location status: Recruiting
NCT Number: NCT05232032
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).
Interested in participating?
Request Info18 year–45 year
All sexes
Interventional
Phase 2
Belmont, Massachusetts, 02478, United States
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for MDD/anxiety disorder group:
Inclusion criteria
for healthy controls:
Exclusion criteria
for all participants:
Participants in the experimental arms will receive 40 mg of the nociceptin receptor antagonist. Peak concentrations are achieved 2-4 hours post-administration.
Other names: BTRX-246040
As part of the approach/avoidance task, electrotactile stimulation will be used. The aversive stimulus is delivered in the form of a mild half-second stimulation to the ankle, calibrated to a subjective threshold that is uncomfortable but not painful. This stimulation is delivered by Digitimer DS8R Constant Current Stimulator (Digitimer North America, LLC. Ft. Lauderdale, FL). Its previous model, DS71, has been safely implemented in studies within Massachusetts General Hospital (Milad et al., 2013).
Time frame: Baseline
Diagnostic assessment
Time frame: Within 30 days of the clinical interview
Both structural and functional brain images
Time frame: During the MRI scan
A novel behavioral task assessing approach/avoidance decision-making
Time frame: On the day of the MRI scan
Measure of Orphanin FQ/Nociceptin
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, 6-month follow-up, 12-month follow-up
Measure of acute events, difficulties, stressors
Time frame: 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
Time frame: Baseline, 6-month follow-up, 12-month follow-up
Suicide assessment
Contact information is provided by the study sponsor or research team.
David Crowley, ALM
CONTACT
Ethan M Zhang, BA
CONTACT
Mclean Hospital
Other
Pharmaco-Neuroimaging Studies of Approach/Avoidance Behaviors and Post-Mortem Studies: Study 1.1. (Pharmacological Manipulation)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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