Exposure therapy is the most effective treatment available for obsessive compulsive disorder, yet up to 50% of patients do not recover because the mechanisms underlying successful response are poorly understood, leading to significant variability in how clinicians conduct exposure therapy. The main purpose of this study is to determine which target mechanisms are most critical to engage in real-world exposure sessions to produce good treatment outcomes. Adult participants (N = 400) with Obsessive Compulsive Disorder (OCD) receiving exposure therapy from two sites (McLean Hospital, San Diego State University) across the continuum of care (outpatient, partial hospital, residential) will complete baseline clinical and demographic measures as well as weekly symptom reports. The project will measure exposure mechanisms across three levels of analysis (self-report, observer-rated behavior, physiology) during each exposure session. Mechanisms assessed will include a broad range of variables based on both habituation and inhibitory learning models of exposure. Self-report and observer-rated mechanisms will be measured with the Exposure Feedback Form, created and piloted by the study team. Physiological mechanisms will include skin conductance response, heart rate, and heart rate variability measured with a wristwatch. The current study will determine (1) which exposure mechanisms lead to favorable clinical outcomes, and (2) what makes a good exposure for whom. Results of this study have the potential to improve personalized care for the many patients who do not remit following exposure therapy for OCD.

开始日期2024-10-16

申办/合作机构

McLean Hospital, Inc.

NCT06636786 / Not yet recruiting临床2期IIT

Prevention/Reduction of ASRs and PTSD to Sustain Civilian Performance With Sublingual Cyclobenzaprine HCl (TNX-102 SL) - (Optimizing Acute Stress Reaction Interventions With TNX-102 SL - OASIS)

This study will examine the safety and efficacy of TNX-102 SL to reduce ASR symptoms and behavioral changes among patients presenting to the emergency department (ED) after motor vehicle collision (MVC). Specifically, the investigators will perform the Optimizing Acute Stress reaction Interventions with TNX-102 SL (OASIS) Trial, a double-blind placebo-controlled randomized clinical trial (RCT) to determine if TNX-102 SL initiated in the ED in the hours after MVC to high risk individuals, treats/reduces acute stress reaction (ASR)/acute stress disorder (ASD) symptoms (primary outcome), improves neurocognitive function, and prevents/reduces posttraumatic stress (PTS) symptoms (secondary outcomes) long term. 180 participants will be randomized, receive study drug in ED and be discharged with a 2-week drug supply. Prior to initial dose of study drug administration, and during the hours, days, and weeks after participants will receive serial longitudinal assessments of psychological and somatic symptoms, neurocognitive function, and adverse events.

开始日期2024-10-01

申办/合作机构

The University of North Carolina at Chapel Hill

[+3]

NCT06105164 / Not yet recruitingN/AIIT

Validation of a Novel Cerebellar-striatal Satiety Circuit in Humans

This study uses a noninvasive technique called transcranial magnetic stimulation (TMS) to study satiety in healthy individuals.
TMS is a noninvasive way of stimulating the brain, using a magnetic field to change activity in the brain. The magnetic field is produced by a coil that is held next to the scalp. In this study, the investigators will be stimulating the brain to learn more about the role of the cerebellum in satiety.

开始日期2024-09-01

申办/合作机构

The Brigham & Women's Hospital, Inc.

[+2]

100 项与 McLean Hospital, Inc. 相关的临床结果

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0 项与 McLean Hospital, Inc. 相关的专利（医药）

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3,715

项与 McLean Hospital, Inc. 相关的文献（医药）

2025-01-01·JOURNAL OF AFFECTIVE DISORDERS

Novel multi-modal methodology to investigate placebo response in major depressive disorder

Article

作者: Origlio, Julianne ; Cusin, Cristina ; Normandin, Marc D ; Kang, Min ; Belleau, Emily ; Dillon, Daniel G ; Fava, Maurizio ; Brunner, Devon ; Petibon, Yoann ; McKee, Madison ; Pizzagalli, Diego A. ; Dhaynaut, Maeva ; Hooker, Jacob ; Dillon, Daniel G. ; Meyer, Ashley ; Jahan, Aava ; Long, Yinru ; Normandin, Marc D. ; Pizzagalli, Diego A ; El-Fakri, Georges ; Hayden, Emma ; Ang, Yuen-Siang ; Kaptchuk, Ted

The neurobiological mechanisms underlying the placebo phenomenon in patients with major depressive disorder (MDD) remain largely unknown. The progressive rise in rates of placebo responses within clinical trials over the past two decades may impede the detection of a true signal and thus present a major obstacle in new treatment development. Understanding the mechanisms would have several important implications, including (1) identifying biomarkers of placebo responders (thereby identifying those individuals who could benefit therapeutically from such interventions), (2) opening new avenues for manipulating such mechanisms to maximize symptom reduction, and (3) refining treatments with approaches that decrease (in clinical trials) or increase (in clinical practice) the placebo response. Here we investigated the research question: is the dopaminergic system one of the neurobiological underpinnings of the placebo response within MDD? Inspired by preclinical and clinical findings that have implicated dopamine in the occurrence, prediction, and expectation of reward, we hypothesized that dopaminergic activity in the mesolimbic system is a critical mediator of placebo response in MDD. To test this hypothesis, we designed a double-blind, placebo-controlled, sequential parallel comparison design clinical trial aimed at maximizing placebo antidepressant response. We integrated behavioral, imaging, and hemodynamic probes of mesocorticolimbic dopaminergic pathways within the context of manipulations of psychological constructs previously linked to placebo responses (e.g., expectation of improvement). The aim of this manuscript is to present the rationale of the study design and to demonstrate how a cross-modal methodology may be utilized to investigate the role of reward circuitry in placebo response in MDD.

2024-12-31·European journal of psychotraumatology

The impact of PTSD on associations between sex hormones and cardiovascular disease symptoms

Article

作者: Seligowski, Antonia V ; Webber, Theresa K ; Jain, Jahnvi ; Merker, Julia B ; Huffman, Jeffery C ; Chen, Joann J

Background: Women have twice the lifetime prevalence of posttraumatic stress disorder (PTSD) relative to men, and PTSD is a known risk factor for cardiovascular disease (CVD). Two sex hormones - estradiol and progesterone - have been found to impact both PTSD and CVD symptomatology, but the way in which sex hormones influence cardiovascular physiology among individuals with PTSD is not well understood.Objective: This study sought to clarify the association between sex hormones, PTSD, and CVD among trauma-exposed women.Method: Sixty-six trauma-exposed women (M age = 31.45, SD = 8.92) completed a clinical interview for PTSD and self-reported CVD symptoms; estradiol and progesterone were assayed from blood samples. The association between each sex hormone and CVD symptoms was analyzed, controlling for age, systolic blood pressure (BP), and diastolic BP.Results: Neither estradiol nor the PTSD-by-estradiol interaction was significantly associated with CVD symptoms. Higher progesterone and, relatedly, progesterone-to-estradiol ratio (PE ratio) were each significantly associated with greater CVD symptom severity, but only for individuals with lower relative PTSD severity.Conclusions: The findings indicate that PTSD moderates the relationship between progesterone and CVD symptoms, and further research is warranted to reconcile findings in existing literature regarding the direction of and mechanisms behind this relationship.

2024-12-31·European journal of psychotraumatology

Circulating PACAP levels are associated with altered imaging measures of entorhinal cortex neurite density in posttraumatic stress disorder

Article

作者: Jobson, Sydney A ; Rauch, Scott L ; Granger, Steven J ; Hammack, Sayamwong E ; Akman, Eylül ; Olson, Elizabeth A ; May, Victor ; Carlezon, William A ; Pernia, Cameron D ; Daskalakis, Nikos P ; Ressler, Kerry J ; Rosso, Isabelle M ; Ravichandran, Caitlin

Introduction: Pituitary adenylate cyclase-activating polypeptide (PACAP) regulates plasticity in brain systems underlying arousal and memory and is associated with posttraumatic stress disorder (PTSD). Research in animal models suggests that PACAP modulates entorhinal cortex (EC) input to the hippocampus, contributing to impaired contextual fear conditioning. In PTSD, PACAP is associated with higher activity of the amygdala to threat stimuli and lower functional connectivity of the amygdala and hippocampus. However, PACAP-affiliated structural alterations of these regions have not been investigated in PTSD. Here, we examined whether peripheral PACAP levels were associated with neuronal morphology of the amygdala and hippocampus (primary analyses), and EC (secondary) using Neurite Orientation Dispersion and Density Imaging.Methods: Sixty-four (44 female) adults (19 to 54 years old) with DSM-5 Criterion A trauma exposure completed the Clinician-Administered PTSD Scale (CAPS-5), a blood draw, and magnetic resonance imaging. PACAP38 radioimmunoassay was performed and T1-weighted and multi-shell diffusion-weighted images were acquired. Neurite Density Index (NDI) and Orientation Dispersion Index (ODI) were quantified in the amygdala, hippocampus, and EC. CAPS-5 total score and anxious arousal score were used to test for clinical associations with brain structure.Results: Higher PACAP levels were associated with greater EC NDI (β = 0.0099, q = 0.032) and lower EC ODI (β = -0.0073, q = 0.047), and not hippocampal or amygdala measures. Neither EC NDI nor ODI was associated with clinical measures.Conclusions: Circulating PACAP levels were associated with altered neuronal density of the EC but not the hippocampus or amygdala. These findings strengthen evidence that PACAP may impact arousal-associated memory circuits in PTSD.

项与 McLean Hospital, Inc. 相关的新闻（医药）

2024-10-06

·奇点网

“聪明药”可不一定真能变聪明！

*仅供医学专业人士阅读参考从几年前到现在，不少新闻都报道了“聪明药”的滥用，传说中，“聪明药”可以让人更专注，不怎么休息也能长时间保持头脑清醒和思维敏捷，所以会有学生在重要考试前夕服用。实际上，这些“聪明药”主要就是治疗注意缺陷/多动障碍（ADHD）的中枢兴奋剂类药物，例如哌甲酯和安非他明，即使前者是我国一类管制精神类药品，后者在我国尚未批准上市，也挡不住一些违规处方和代购。但是，中枢兴奋剂类药物也有相应的不良反应，包括头晕、头痛、失眠、眩晕、心悸和胃肠道反应等。甚至安非他明由于显著增加突触前多巴胺释放量，与精神疾病患者中观察到的现象一致，而存在增加精神疾病风险的担忧。在最近的《美国精神病学杂志》上，美国麦克莱恩医院的研究团队通过病例对照研究揭示，与过去一个月内未服用相比，服用安非他明与精神疾病和躁狂症风险增加168%有关，且存在剂量反应关系，高剂量（＞30mg右旋安非他明当量）与风险增加428%有关，相比之下，服用哌甲酯则与风险增加无关[1]。这项研究使用麻省总医院百瀚医疗系统（MGB）的电子医疗记录数据，纳入了2005-2019年间在麦克莱恩医院首次因精神疾病或躁狂症入院的16-35岁患者作为病例组，研究人员为每位患者匹配了2名没有精神疾病和躁狂症史，因抑郁和/或焦虑障碍入院的患者作为对照组。病例组和对照组分别纳入了1374例和2748例患者，病例组中，60.6%因精神疾病入院，28.2%因有精神疾病特征的发作性躁狂症入院，11.1%因无精神疾病特征的发作性躁狂症入院。研究筛选流程和最终入组人数在过去一个月中，有415例参与者服用过安非他明，病例组和对照组分别为204例和211例，病例组报告非处方中枢兴奋剂类药物滥用的更多，但大多数参与者仍然是通过处方获取安非他明的（病例组和对照组分别为79.4%和89.1%）。在校正了人口统计学因素、基础精神疾病、精神类药物和家族史因素后，研究人员发现，与未服用相比，过去一个月内服用安非他明与精神疾病和躁狂症风险增加168%有关，且存在剂量反应关系，低（≤15mg）、中（＞15至30mg）和高（＞30mg）剂量分别与风险增加79%、251%和428%有关。病例组与对照组在过去一个月内服用安非他明的情况和精神疾病/躁狂症风险在精神疾病和躁狂症的风险归因占比方面，任意剂量的处方安非他明为62.7%，高剂量为81.0%。研究人员还发现，在≤22岁的参与者中，安非他明的影响小于＞22岁的参与者，风险增加分别为126%和310%。在不同性别中没有这样的差异。在过去一个月内，病例组和对照组分别有37例和102例参与者服用哌甲酯，与未服用相比，服用哌甲酯与精神疾病和躁狂症的风险增加无关，参与者的哌甲酯服用剂量显著低于安非他明（平均右旋安非他明当量：哌甲酯为18.1mg，安非他明为25.2mg）。综上所述，服用安非他明与精神疾病和躁狂症的风险显著增加有关，并且风险会随着剂量的升高而升高，而哌甲酯与风险增加无关。这一结果与此前一项大型队列发现的，安非他明相比哌甲酯与精神疾病风险增加有关[2]相一致。研究人员指出，中枢兴奋剂类药物的标签上没有剂量上限，为患者开具的药物剂量主要取决于医生对病情严重程度的判断，但根据本研究的结果，精神疾病和躁狂症的风险会随药物剂量增加，需要引起注意。至于想要尝试“聪明药”的朋友，最好也还是收手吧~参考文献：[1] Moran L V, Skinner J P, Shinn A K, et al. Risk of Incident Psychosis and Mania With Prescription Amphetamines[J]. American Journal of Psychiatry, 2024: appi. ajp. 20230329.[2] Moran L V, Ongur D, Hsu J, et al. Psychosis with methylphenidate or amphetamine in patients with ADHD[J]. New England Journal of Medicine, 2019, 380(12): 1128-1138.本文作者丨应雨妍

临床结果

2024-10-03

·mobihealthnews

Virtual dementia care platform Rippl scores $23M

Rippl, a company focused on providing mental health solutions to seniors with dementia and other cognitive conditions, announced it closed a $23 million Series A funding round. Tina Hoang-To, Kin Ventures' founding general partner, led the round, with participation from the company's seed investors General Catalyst, ARCH Ventures, GV (Google Ventures), Mass General Brigham Ventures, F-Prime and 1843 Capital. JSL Health joined the round as well. WHAT IT DOES The company offers a dementia-care platform that provides patients and caregivers with care-navigation and coordination services, counseling, medication management, support groups, educational content and other tools to enhance one's quality of life. Rippl also offers at-home monitoring to help predict a patient's care needs. The Seattle-based company, led by Starbucks veteran Kris Engskov, will use the funds to enhance its technology and expand its value-based care partnerships and geographic footprint. "In addition to our value-based arrangements with Medicare Advantage plans, we are thrilled to be collaborating with major health systems like Houston Methodist, Springfield Clinic, St. Luke’s Hospital and Providence Health as part of the CMS GUIDE program to extend our reach. These partners share our deep passion for improving quality of life for people living with dementia and their caregivers," JP Sharp, chief growth officer at Rippl, said in a statement. MARKET SNAPSHOT Rippl launched in 2022 with $32 million in seed funding. At the time, it planned to use the funds to hire and train clinicians, build its technology, and open a Washington state-based clinical support center to launch pilot networks in two regions, starting in Seattle. Earlier this year, the company announced it acquired Boston-based Kinto, an AI-enabled dementia caregiver support and education platform. Last year, the company partnered with Mass General Brigham's McLean Hospital to enhance the training and development of a specialty workforce to care for seniors with dementia and other neurocognitive diseases. Other companies focused on providing digital health solutions to the dementia population include Harmonic Health, a tech-enabled dementia care platform, and Japanese pharmaceutical company Eisai, which established a new digital health business targeting dementia last year.

并购

2024-09-17

·drugs

Rx Amphetamine Use Linked to Increased Odds of Psychosis, Mania

TUESDAY, Sept. 17, 2024 -- Past-month prescription amphetamine use is associated with increased odds of psychosis and mania , with increased odds for high doses (>30 mg dextroamphetamine equivalents), according to a study published online Sept. 12 in The American Journal of Psychiatry . Lauren V. Moran, M.D., M.P.H., from McLean Hospital in Belmont, Massachusetts, and colleagues conducted a case-control study using electronic health records to compare the odds of incident psychosis or mania with past-month exposure to prescription amphetamines. Cases were patients aged 16 to 35 years hospitalized for incident psychosis or mania between 2005 and 2019 (1,374 individuals), and controls were patients with an initial psychiatric hospitalization for other reasons, most commonly depression and/or anxiety (2,748 individuals). The researchers found that compared with no use, past-month prescription amphetamine use was associated with increased odds of psychosis and mania among cases and controls (adjusted odds ratio, 2.68; 95 percent confidence interval, 1.90 to 3.77). There was a dose-response relationship, with high doses of amphetamines (>30 mg dextroamphetamine equivalents) associated with 5.28-fold increased odds of psychosis or mania. Compared with no use, past-month methylphenidate use was not associated with increased odds of psychosis or mania (adjusted odds ratio, 0.91; 95 percent confidence interval, 0.54 to 1.55). "The clinical utility of prescribing doses of amphetamines that exceed 30 mg dextroamphetamine equivalents is unproven; coupled with the elevated risk of inducing psychosis or mania, we recommend minimizing this practice," the authors write. Several authors disclosed ties to the pharmaceutical industry.

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