Investigating the Effect of TNX-1900 on Pain Management, Neural and Socio-Emotional Functioning in Patients Undergoing Pituitary Surgery
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Change in post-operative pain measured by the Numeric Pain Rating Scale (NPRS)
研究概览
简要总结
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.
详细描述
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/ERP) will be included throughout the protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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/or 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
结局指标
主要结局
Change in post-operative pain measured by the Numeric Pain Rating Scale (NPRS)
时间窗: Pre-op up to 8 weeks after last drug administration
The NPRS is a patient-reported tool used to assess pain intensity on a scale from 0 (no pain) to 10 (worst possible pain).
Change in post-operative pain measured by monitoring of pain medication usage
时间窗: Pre-op up to 8 weeks after last drug administration
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.
次要结局
- Changes in participant reported depression as measured by the Beck Depression Inventory (BDI-II)(Pre-op up to 8 weeks after last drug administration)
- Changes in participant reported anxiety as measured by the Beck Anxiety Inventory (BAI)(Pre-op up to 8 weeks after last drug administration)
- Changes in participant reported anxiety as measured by the Generalized Anxiety Disorder-7(Pre-op up to 8 weeks after last drug administration)
- Changes in participant reported depression as measured by the Patient Health Questionnaire-9(Pre-op up to 8 weeks after last drug administration)
- Change in neural functioning measured by Electroencephalography (EEG)/Event-Related Potential (ERP)(Pre-op and the last day of drug administration, approximately 14 days)
研究者
Sacit Omay
Associate Professor of Neurosurgery and Otolaryngology
Yale University