[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07730294":3,"trial-entities:NCT07730294":128,"trial-summary:NCT07730294":132},{"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":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":50,"secondary_outcomes":58,"sex":75,"minimum_age":76,"maximum_age":77,"healthy_volunteers":78,"eligibility_criteria":79,"std_ages":96,"locations":99,"central_contacts":120,"overall_officials":123,"references":126,"see_also_links":127},"NCT07730294","2000042469","Evaluating Intranasal Oxytocin (TNX-1900) for Pain Relief and Recovery After Pituitary Surgery","Investigating the Effect of TNX-1900 on Pain Management, Neural and Socio-Emotional Functioning in Patients Undergoing Pituitary Surgery","NOT_YET_RECRUITING","2028-08","2026-07","2026-07-28","2026-08","Yale University","OTHER",true,"This study is testing whether oxytocin can help lessen pain by changing how people process emotions and social experiences. The goal is to better understand how the brain links emotions, relationships, and pain, and whether this connection can be used to improve pain treatment.","This study employs a randomized, double-blind, placebo-controlled design to evaluate the efficacy of an intranasal oxytocin formulation, TNX-1900, on pain management, neural functioning, and socio-emotional health in patients undergoing pituitary surgery. Participants will be randomized into 3 groups: One group will receive low-dose oxytocin (6 IU), one group will receive high-dose oxytocin (24 IU), and one group will receive a matching placebo formulation. Participants will administer their nasal spray (blinded) daily for 7 days leading up to, and including the day of surgery, and 7 days following the surgery. Assessments (surveys and EEG\u002FERP) will be included throughout the protocol.",[19,20],"Pain","Pituitary Surgery",[22,23,24,25],"pain","pain perception","oxytocin","intranasal","INTERVENTIONAL","TREATMENT",[29],"PHASE2",{"count":31,"type":32},75,"ESTIMATED",[34,40,45],{"type":35,"name":36,"description":37,"armGroupLabels":38},"DRUG","Oxytocin (Low dose)","The dosage for low -dose intranasal oxytocin is set at 6 International Units (IU) per day, divided into two administrations of 3IU each per nostril. The administration begins one week prior to surgery, continues on the day of the surgery, and extends through the week following the surgery.",[39],"Low Dose Oxytocin",{"type":35,"name":41,"description":42,"armGroupLabels":43},"Oxytocin (High dose)","The dosage for high-dose intranasal oxytocin is set at 24 International Units (IU) per day, divided into two administrations of 12 IU each per nostril. The administration begins one week prior to surgery, continues on the day of the surgery, and extends through the week following the surgery.",[44],"High Dose Oxytocin",{"type":35,"name":46,"description":47,"armGroupLabels":48},"Placebo (saline)","Placebo nasal spray (no study medication, magnesium only). The administration begins one week prior to surgery, continues on the day of the surgery, and extends through the week following the surgery.",[49],"Saline-Mg solution",[51,55],{"measure":52,"description":53,"timeFrame":54},"Change in post-operative pain measured by the Numeric Pain Rating Scale (NPRS)","The NPRS is a patient-reported tool used to assess pain intensity on a scale from 0 (no pain) to 10 (worst possible pain).","Pre-op up to 8 weeks after last drug administration",{"measure":56,"description":57,"timeFrame":54},"Change in post-operative pain measured by monitoring of pain medication usage","Daily pain medication usage will be reported by participants leading up to surgery and after discharge. Daily pain medication usage will be reported through the participant's medical record during surgery and inpatient stay.",[59,62,65,68,71],{"measure":60,"description":61,"timeFrame":54},"Changes in participant reported depression as measured by the Beck Depression Inventory (BDI-II)","BDI-II is a 21-item patient-reported questionnaire used to assess the severity of depressive symptoms. Total scores range from 0 to 63, with higher scores indicating more severe depression.",{"measure":63,"description":64,"timeFrame":54},"Changes in participant reported anxiety as measured by the Beck Anxiety Inventory (BAI)","BAI is a 21-item patient-reported questionnaire used to assess the severity of anxiety symptoms. Total scores range from 0 to 63, with higher scores indicating more severe anxiety.",{"measure":66,"description":67,"timeFrame":54},"Changes in participant reported anxiety as measured by the Generalized Anxiety Disorder-7","GAD-7 is a 7-item patient-reported questionnaire used to assess the severity of anxiety symptoms. Total scores range from 0 to 21, with higher scores indicating more severe anxiety.",{"measure":69,"description":70,"timeFrame":54},"Changes in participant reported depression as measured by the Patient Health Questionnaire-9","PHQ-9 is a 9-item patient-reported questionnaire used to assess the severity of depressive symptoms. Total scores range from 0 to 27, with higher scores indicating more severe depression.",{"measure":72,"description":73,"timeFrame":74},"Change in neural functioning measured by Electroencephalography (EEG)\u002FEvent-Related Potential (ERP)","EEG\u002FERP sessions are done at specific intervals to look at delta-beta neural oscillations and N170, P300, and LPP ERPs elicited by social and emotional stimuli (photos of faces and houses).","Pre-op and the last day of drug administration, approximately 14 days","ALL","30 Years","75 Years",false,{"inclusion":80,"exclusion":86,"raw_text":95},[81,82,83,84,85],"Age: Between 30 to 75 years old.","Consent: Ability to give informed consent.","Language: Proficiency in the English language.","Medical Condition: Diagnosed with a pituitary lesion requiring surgery.","Menopausal Status: Post-menopause for women (at least 1 year since last menstrual period).",[87,88,89,90,91,92,93,94],"Medication: Individuals on stable doses of psychotropic medication for at least the past six weeks are eligible, excluding those with changes in medication within that timeframe.","Neurological Conditions: A history of seizures, current use of anticonvulsants.","Pregnancy: Currently pregnant, currently lactating, or up to 1-year post partum.","Any history of renal impairment (serum creatinine \\>1.2 x ULN)","Any history of hepatic impairment (AST and\u002For ALT \\>2 x ULN)","Surgical History: Any history of previous pituitary surgery procedures","Subjects who require 24-hour coverage with NSAIDs, e.g., arthritis, should not be included in the study.","Any known hypersensitivity to TNX-1900","Inclusion Criteria:\n\n* Age: Between 30 to 75 years old.\n* Consent: Ability to give informed consent.\n* Language: Proficiency in the English language.\n* Medical Condition: Diagnosed with a pituitary lesion requiring surgery.\n* Menopausal Status: Post-menopause for women (at least 1 year since last menstrual period).\n\nExclusion Criteria:\n\n* Medication: Individuals on stable doses of psychotropic medication for at least the past six weeks are eligible, excluding those with changes in medication within that timeframe.\n* Neurological Conditions: A history of seizures, current use of anticonvulsants.\n* Pregnancy: Currently pregnant, currently lactating, or up to 1-year post partum.\n* Any history of renal impairment (serum creatinine \\>1.2 x ULN)\n* Any history of hepatic impairment (AST and\u002For ALT \\>2 x ULN)\n* Surgical History: Any history of previous pituitary surgery procedures\n* Subjects who require 24-hour coverage with NSAIDs, e.g., arthritis, should not be included in the study.\n* Any known hypersensitivity to TNX-1900",[97,98],"ADULT","OLDER_ADULT",[100],{"facility":13,"city":101,"state":102,"zip":103,"country":104,"contacts":105,"geoPoint":117},"New Haven","Connecticut","06510","United States",[106,111,114,116],{"name":107,"role":108,"phone":109,"email":110},"S. Bulent Omay, MD","CONTACT","203-737-6885","sacit.omay@yale.edu",{"name":112,"role":108,"email":113},"Helena Rutherford, PhD","helena.rutherford@yale.edu",{"name":107,"role":115},"PRINCIPAL_INVESTIGATOR",{"name":112,"role":115},{"lat":118,"lon":119},41.30815,-72.92816,[121,122],{"name":107,"role":108,"phone":109,"email":110},{"name":112,"role":108,"email":113},[124,125],{"name":107,"affiliation":13,"role":115},{"name":112,"affiliation":13,"role":115},[],[],{"nct_id":4,"conditions":129,"biomarkers":131},[130],"Pituitary Lesion",[],{"nct_id":4,"found":15,"summary":133,"prompt_version":142},{"design":134,"status":135,"heading":6,"summary":136,"follow_up":137,"word_count":138,"commitments":139,"compensation":140,"drugs_mentioned":141},"This is a randomized, double-blind, placebo-controlled study with 75 participants. This means participants will be randomly assigned to receive either a low dose of oxytocin, a high dose of oxytocin, or a placebo (a nasal spray with no active medicine), and neither you nor your doctors will know which one you are receiving.","completed","This study is testing if a nasal spray called oxytocin (TNX-1900) can help reduce pain and improve recovery after pituitary surgery. Researchers believe oxytocin might help by changing how your brain processes emotions and social experiences, which could affect pain. You might be able to join if you are between 30 and 75 years old, speak English, and need surgery for a pituitary lesion (a growth on your pituitary gland). Women must be post-menopausal (at least one year since your last period). The study will look at how much your pain changes after surgery and how much pain medication you use. The current recruitment status is unclear.","Your pain levels and pain medication use will be monitored from before surgery up to 8 weeks after your last dose of the study medication.",107,"You would use a nasal spray daily for one week before surgery, on the day of surgery, and for one week after surgery. You will also complete surveys and have brain activity measurements (EEG\u002FERP) throughout the study.","Not stated in the trial record.",[],"v2"]