[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100457087":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":42,"centralContacts":46,"locations":56,"responsibleParty":74,"collaborators":77,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":41,"eligibilityCriteria":95,"healthyVolunteers":96,"sex":97,"minAge":98,"maxAge":99,"enrollmentInfo":100,"targetDuration":41,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":41,"overallStatus":58,"whyStopped":41,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Mclean Hospital","OTHER",[8,15,20,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Participants with MDD or an anxiety disorder receiving the nociceptin receptor antagonist","EXPERIMENTAL","After a diagnostic interview (determining the presence of MDD or an anxiety disorder) and collection of blood for Orphanin FQ\u002FNociceptin assays, participants will receive the nociceptin receptor antagonist. Participants will then complete an approach\u002Favoidance task. Functional magnetic resonance imagining (fMRI) will begin 2 hours after the nociceptin receptor antagonist is administered.",[13,14],"Drug: Nociceptin Receptor Antagonist","Device: Aversive stimuli",{"label":16,"type":17,"description":18,"interventionNames":19},"Participants with MDD or an anxiety disorder receiving the placebo","PLACEBO_COMPARATOR","After a diagnostic interview (determining the presence of MDD or an anxiety disorder) and collection of blood for Orphanin FQ\u002FNociceptin assays, participants will receive the placebo. Participants will then complete an approach\u002Favoidance task. fMRI will begin 2 hours after the placebo is administered.",[14],{"label":21,"type":10,"description":22,"interventionNames":23},"Healthy controls receiving the nociceptin receptor antagonist","After a diagnostic interview (determining healthy control status) and collection of blood for Orphanin FQ\u002FNociceptin assays, participants will receive a nociceptin receptor antagonist. Participants will then complete an approach\u002Favoidance task. fMRI will begin 2 hours after the nociceptin receptor antagonist is administered.",[13,14],{"label":25,"type":17,"description":26,"interventionNames":27},"Healthy controls receiving the placebo","After a diagnostic interview (determining healthy control status) and collection of blood for Orphanin FQ\u002FNociceptin assays, participants will receive the placebo. Participants will then complete an approach\u002Favoidance task. fMRI will begin 2 hours after the placebo is administered.",[14],[29,36],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","Nociceptin Receptor Antagonist","Participants in the experimental arms will receive 40 mg of the nociceptin receptor antagonist. Peak concentrations are achieved 2-4 hours post-administration.",[21,9],[35],"BTRX-246040",{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"DEVICE","Aversive stimuli","As part of the approach\u002Favoidance 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).",[21,25,9,16],null,[43],{"name":44,"affiliation":5,"role":45},"Diego Pizzagalli, Ph.D.","PRINCIPAL_INVESTIGATOR",[47,52],{"name":48,"role":49,"phone":50,"phoneExt":41,"email":51},"Ethan M Zhang, BA","CONTACT","617-855-4434","ezhang24@mclean.harvard.edu",{"name":53,"role":49,"phone":54,"phoneExt":41,"email":55},"David Crowley, ALM","617-855-4432","djcrowley@mclean.harvard.edu",[57],{"facility":5,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"RECRUITING","Belmont","Massachusetts","02478","United States","US",{"type":65,"coordinates":66},"Point",[67,68],-71.17867,42.39593,{"lat":68,"lon":67},[71,73],{"name":72,"role":49,"phone":50,"phoneExt":41,"email":51},"Ethan Zhang, BA",{"name":53,"role":49,"phone":41,"phoneExt":41,"email":55},{"type":45,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"Diego Pizzagalli","Professor, Department of Psychiatry, Harvard Medical School, McLean Hospital, McLean Hospital",[78,81,83,85,87],{"name":79,"class":80},"National Institute of Mental Health (NIMH)","NIH",{"name":82,"class":6},"Massachusetts General Hospital",{"name":84,"class":6},"Massachusetts Institute of Technology",{"name":86,"class":6},"University of Washington",{"name":88,"class":6},"Brown University","100457087","phase-2-pharmaco-neuroimaging-studies-of-approachavoidance-behaviors-and-post-mortem-studies-pharmacological-manipulation-100457087",false,"NCT05232032","Pharmaco-Neuroimaging Studies of Approach\u002FAvoidance Behaviors and Post-Mortem Studies: Pharmacological Manipulation","Pharmaco-Neuroimaging Studies of Approach\u002FAvoidance Behaviors and Post-Mortem Studies: Study 1.1. (Pharmacological Manipulation)","Inclusion criteria for MDD\u002Fanxiety disorder group:\n\n* DSM-5 diagnostic criteria for MDD, Generalized Anxiety Disorder, Social Phobia, Panic Disorder, Post Traumatic Stress (diagnosed using the SCID-5)\n* Written informed consent\n* For MDD subjects, a baseline Hamilton Depression Rating Scale score \\> 16 (17-item version)\n* Right-handed\n* Has a smartphone (iPhone or Android) (needed for Ecological Momentary Assessment)\n* Absence of any psychotropic medications for at least 2 weeks (6 weeks for fluoxetine, 6 months for neuroleptics, 2 weeks for benzodiazepines, 2 weeks for any other antidepressants)\n\nInclusion criteria for healthy controls:\n\n* Absence of medical, neurological, and psychiatric illness (including alcohol and substance abuse), as assessed by subject history and a structured clinical interview (diagnosed using the SCID-5)\n* Written informed consent\n* Right-handed\n* Absence of any medications for at least 3 weeks\n* Has a smartphone (iPhone or Android) (needed for Ecological Momentary Assessment)\n\nExclusion criteria for all participants:\n\n* Subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician\n* Pregnant women or women of childbearing potential who are not using a medically accepted means of contraception\n* Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease\n* History of seizure disorder\n* History or current diagnosis of any of the following DSM-IV psychiatric illnesses: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, obsessive-compulsive disorder, patients with mood congruent or mood incongruent psychotic features, substance dependence, substance abuse within the last 12 months (with the exception of cocaine or stimulant abuse; which will lead to exclusion)\n* History of cocaine or stimulant use (e.g., amphetamine, cocaine, methamphetamine)\n* History of use of dopaminergic drugs (including methylphenidate)\n* History or current diagnosis of dementia\n* Patients with mood congruent or mood incongruent psychotic features\n* Current use of other psychotropic drugs\n* Clinical or laboratory evidence of hypothyroidism\n* Patients with a lifetime history of electroconvulsive therapy\n* Failure to meet standard magnetic resonance imaging safety requirements\n* Abnormal ECG and lab results\n* History of seizure disorder or currently on anticonvulsants",true,"ALL","18 Years","45 Years",{"count":101,"type":102},112,"ESTIMATED","INTERVENTIONAL",[105],"PHASE2","The study will investigate whether a nociceptin receptor antagonist will normalize neural and behavioral processes of approach\u002Favoidance 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\u002Forphanin FQ peptide and the nociceptin receptor (NOPR).",[108,109],"Depressive Disorder, Major","Anxiety Disorder","2026-05-15",{"date":112,"type":113},"2026-05-18","ACTUAL",{"date":115,"type":113},"2025-02-01",{"date":117,"type":102},"2027-03-31",{"name":5,"class":6},1]