[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05232032":3,"trial-entities:NCT05232032":157,"trial-summary:NCT05232032":161},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":46,"secondary_outcomes":63,"sex":96,"minimum_age":97,"maximum_age":98,"healthy_volunteers":15,"eligibility_criteria":99,"std_ages":126,"locations":128,"central_contacts":146,"overall_officials":151,"references":155,"see_also_links":156},"NCT05232032","2024P002715","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)","RECRUITING","2027-03-31","2026-05","2026-05-18","2025-02-01","Mclean Hospital","OTHER",true,"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).",null,[19,20],"Depressive Disorder, Major","Anxiety Disorder",[],"INTERVENTIONAL","BASIC_SCIENCE",[25],"PHASE2",{"count":27,"type":28},112,"ESTIMATED",[30,39],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":37},"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.",[35,36],"Healthy controls receiving the nociceptin receptor antagonist","Participants with MDD or an anxiety disorder receiving the nociceptin receptor antagonist",[38],"BTRX-246040",{"type":40,"name":41,"description":42,"armGroupLabels":43},"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).",[35,44,36,45],"Healthy controls receiving the placebo","Participants with MDD or an anxiety disorder receiving the placebo",[47,51,55,59],{"measure":48,"description":49,"timeFrame":50},"Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (SCID-5)","Diagnostic assessment","Baseline",{"measure":52,"description":53,"timeFrame":54},"Magnetic Resonance Imagining","Both structural and functional brain images","Within 30 days of the clinical interview",{"measure":56,"description":57,"timeFrame":58},"Approach\u002FAvoidance Task","A novel behavioral task assessing approach\u002Favoidance decision-making","During the MRI scan",{"measure":60,"description":61,"timeFrame":62},"Orphanin FQ\u002FNociceptin assays (using blood samples)","Measure of Orphanin FQ\u002FNociceptin","On the day of the MRI scan",[64,68,71,74,77,80,83,86,89,93],{"measure":65,"description":66,"timeFrame":67},"Beck Depression Inventory-II","21-item measure of depression severity; scores range from 0 to 63; higher scores indicate higher depression severity","Baseline, 6-month follow-up, 12-month follow-up",{"measure":69,"description":70,"timeFrame":67},"Hamilton Rating Scale for Depression","17-item measure of depression severity; scores range from 0 to 34; higher scores indicate higher depression severity",{"measure":72,"description":73,"timeFrame":67},"Perceived Stress Scale","14-item measure of stress appraisal; scores range from 0 to 56; higher scores indicate higher perceived stress",{"measure":75,"description":76,"timeFrame":67},"Snaith Hamilton Pleasure Scale","14-item measure of anhedonia; scores range from 14 to 56; higher scores indicate higher anhedonia",{"measure":78,"description":79,"timeFrame":67},"Medical Outcome Survey- Short Form","36-item measure of physical and social functioning; score range from 36 to 149; higher scores indicate higher physical and social functioning",{"measure":81,"description":82,"timeFrame":67},"Quality of Life Enjoyment and Satisfaction Questionnaire","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",{"measure":84,"description":85,"timeFrame":67},"Temporal Experience of Pleasure Scale","24-item measure of anticipatory and consummatory pleasure; scores range from 24 to 144; higher scores indicate higher anticipatory\u002Fconsummatory pleasure",{"measure":87,"description":88,"timeFrame":67},"Life Events and Difficulties Schedule","Measure of acute events, difficulties, stressors",{"measure":90,"description":91,"timeFrame":92},"Longitudinal Interval Follow-Up Evaluation (LIFE) (Keller et al., 1987)","Retrospectively assesses different DSM-5 disorders, social and occupational functioning, and life satisfaction over the past 6 months","6-month follow-up, 12-month follow-up",{"measure":94,"description":95,"timeFrame":67},"Columbia-Suicide Severity Rating Scale","Suicide assessment","ALL","18 Years","45 Years",{"inclusion":100,"exclusion":109,"raw_text":125},[101,102,103,104,105,106,107,102,104,108,105],"DSM-5 diagnostic criteria for MDD, Generalized Anxiety Disorder, Social Phobia, Panic Disorder, Post Traumatic Stress (diagnosed using the SCID-5)","Written informed consent","For MDD subjects, a baseline Hamilton Depression Rating Scale score \\> 16 (17-item version)","Right-handed","Has a smartphone (iPhone or Android) (needed for Ecological Momentary Assessment)","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)","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)","Absence of any medications for at least 3 weeks",[110,111,112,113,114,115,116,117,118,119,120,121,122,123,124],"Subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician","Pregnant women or women of childbearing potential who are not using a medically accepted means of contraception","Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease","History of seizure disorder","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)","History of cocaine or stimulant use (e.g., amphetamine, cocaine, methamphetamine)","History of use of dopaminergic drugs (including methylphenidate)","History or current diagnosis of dementia","Patients with mood congruent or mood incongruent psychotic features","Current use of other psychotropic drugs","Clinical or laboratory evidence of hypothyroidism","Patients with a lifetime history of electroconvulsive therapy","Failure to meet standard magnetic resonance imaging safety requirements","Abnormal ECG and lab results","History of seizure disorder or currently on anticonvulsants","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",[127],"ADULT",[129],{"facility":13,"status":8,"city":130,"state":131,"zip":132,"country":133,"contacts":134,"geoPoint":143},"Belmont","Massachusetts","02478","United States",[135,140],{"name":136,"role":137,"phone":138,"email":139},"Ethan Zhang, BA","CONTACT","617-855-4434","ezhang24@mclean.harvard.edu",{"name":141,"role":137,"email":142},"David Crowley, ALM","djcrowley@mclean.harvard.edu",{"lat":144,"lon":145},42.39593,-71.17867,[147,149],{"name":148,"role":137,"phone":138,"email":139},"Ethan M Zhang, BA",{"name":141,"role":137,"phone":150,"email":142},"617-855-4432",[152],{"name":153,"affiliation":13,"role":154},"Diego Pizzagalli, Ph.D.","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":158,"biomarkers":160},[20,159],"Unipolar Depression",[],{"nct_id":4,"found":15,"summary":162,"prompt_version":172},{"design":163,"status":164,"heading":165,"summary":166,"follow_up":167,"word_count":168,"commitments":169,"compensation":170,"drugs_mentioned":171},"This is an interventional study planning to enroll 112 participants. It is not specified if it is randomized or blinded, and the phase is not specified.","completed","Nociceptin Receptor Antagonist for Depression and Anxiety","This study is looking at how a medication called a nociceptin receptor antagonist might help people with major depressive disorder (MDD) and anxiety disorders. Researchers want to see if this drug can help normalize how your brain and behavior respond to situations where you have to decide to approach or avoid something. You might be eligible if you are between 18 and 45 years old, have a diagnosis of MDD or certain anxiety disorders, and have a Hamilton Depression Rating Scale score above 16. The study involves receiving 40 mg of the nociceptin receptor antagonist and undergoing an MRI scan while performing a task that uses mild electrical stimulation on your ankle. The current status of this study is unclear, but it plans to enroll 112 participants.","The primary endpoints are measured at baseline, within 30 days of the clinical interview, and during the MRI scan. It is not specified if there is follow-up after these measurements.",127,"You would undergo a clinical interview, receive 40 mg of the nociceptin receptor antagonist, and have an MRI scan while performing an approach\u002Favoidance task with mild electrical stimulation to your ankle.","Not stated in the trial record.",[32],"v2"]