Journey Clinical’s Post

In this issue, we look at Incannex Healthcare Inc's topline results from its Phase 2a study of psilocybin-assisted psychotherapy for generalised anxiety disorder, along with other headlines. Despite its relatively small sample size and potential blinding issues, the Incannex-sponsored study is an important contribution to the literature, given it’s the first to evaluate psilocybin for a primary anxiety disorder. It’s also the first psychedelic trial from Incannex, which primarily develops cannabinoid-based drug candidates. The commercial case for the Psi-GAD intervention remains an open question, however, given the lack of clarity surrounding the candidate’s defensibility, scalability, and competitiveness. The company appears set on launching a larger, multi-site Phase 2b study, however, which will no doubt represent a substantial contribution to the literature. Available to read (for Pα+ subscribers) via the link in the comments.

October is #Depression Awareness Month, a time to highlight the importance of research in advancing treatment options and expanding access to treatment. There are unique complexities that need to be considered and planned for in order to successfully conduct clinical research in depression to find better treatments. Read this Medpace article to explore the challenges of conducting depression clinical research from an operational, medical, and patient perspective: https://lnkd.in/gG5UvJpv

The FDA’s Decision on MDMA-Assisted Psychotherapy: OPEN Foundation calls for pragmatism and scientific rigor Full blog post: https://lnkd.in/eaSFZGXb The recent decision by the US Food and Drug Administration (FDA) to withhold approval for MDMA-assisted psychotherapy (MDMA-AT) has sparked significant concern within the scientific and therapeutic communities. Despite the promising evidence supporting MDMA-AT as an effective treatment for Post-Traumatic Stress Disorder (PTSD), the FDA's decision has delayed access to this potentially life-changing therapy for millions of patients. At the OPEN Foundation, we believe this decision underscores the need for a balanced approach — one that upholds rigorous scientific standards while also addressing the urgent needs of patients. By exploring the contrasting perspectives of regulatory bodies, such as the Dutch State Committee on MDMA, and addressing key methodological and ethical considerations, we advocate for a path forward that emphasizes both scientific integrity and compassionate pragmatism. Full blog post: https://lnkd.in/eaSFZGXb

A recent study published in PLOS ONE suggests that the severity of anxiety did not increase overall during the COVID-19 pandemic, and this trend was consistent among patients already receiving outpatient treatment for anxiety prior to the pandemic. Led by David H. Rosmarin from McLean Hospital and Steven Pirutinsky from Touro College, the study analyzed responses to cognitive behavioral therapy (CBT) among 764 psychotherapy outpatients. The findings provide insights into the resilience of individuals and the effectiveness of therapy amidst challenging circumstances. #Anxiety #Pandemic #CBT 🧠💼📊

Registration is free for our Sunday Conversations,1/21 at 4pm ET. When a patient consults a physician and reports symptoms that refer to multiple unrelated organ systems which do not fit with known patterns or conditions, and when the laboratory tests that are conventionally run do not reveal any abnormalities, the conclusion is reached that they should see a psychiatrist… In my clinical practice, patients with this presentation are frequently suffering from Mast Cell Activation Syndrome (MCAS), the most common cause of which is environmental from mold toxins. Many of these patients also suffer from the connective tissue disorder, Ehlers Danlos Syndrome (EDS). This talk will be a discussion of the multi-modal holistic approach that I take in my practice to the treatment of these three conditions (MCAS, Mold Toxicity, EDS) which so often manifest with depression, anxiety, insomnia, inattention, and brain fog and thus commonly result in referral to a psychiatrist. Judy Suzanne Reis Tsafrir, MD, is a holistic healer, activist, artist, and gardener with a private practice of holistic psychiatry and psychoanalysis located in Newton, Massachusetts. She is a board-certified adult and child psychiatrist and psychoanalyst, is on the faculty of Harvard Medical School and the Boston Psychoanalytic Institute and teaches and supervises at the Cambridge Health Alliance. She has particular interest in combining spiritual and developmental approaches to healing, ketamine assisted psychotherapy, helping patients wean from psychiatric medications, and treating complex chronic medical conditions that present psychiatrically, including mold toxicity, mast cell activation, and Ehlers Danlos Syndrome. https://lnkd.in/eu3wM2QC... #massmecfs #chronicfatigue #longcovid #MyalgicEncephalomyelitis

Elevate your understanding of psychopharmacology with our comprehensive seminar, Psychopharmacology Made Simple. Designed for both prescribing and non-prescribing clinicians, this session will provide you with a strong foundation in the principles and practices of managing psychiatric medications, especially in patients with chronic medical conditions. 🔍 What You Will Learn: Neurobiological basis of mental health disorders and psychotropic medications Overview of different classes of psychotropic medications: antidepressants, antipsychotics, anxiolytics, mood stabilizers, stimulants Indications, contraindications, and side effects of various medications Emerging trends in clinical psychopharmacology, including personalized medicine and novel treatments Effective communication and collaboration with prescribing professionals Recognize red flags and adverse effects to enhance patient safety Join us for this 1-hour seminar to boost your confidence and skills in managing psychiatric medications and enhance patient outcomes in mental health care. 📅 Date: Sunday, August 18, 2024 ⏰ Time: 3-4pm (EDT) . 🔗 Register Now to secure your spot and earn 1 CE credit! https://lnkd.in/drNQthPe . . . #psychopharmacology #mentalhealth #ceus #clinicaleducation #psychiatricmedications #healthcareprofessionals #mentalhealthcare #patientcare #chronicconditions #onlinelearning #medicaleducation #sweetinstitute

Exciting news for mental health! MDMA-assisted psychotherapy is on the verge of FDA approval for treating PTSD. Success here could pave the way for psilocybin and LSD to be cleared for use in depression, anxiety, substance abuse, and other mental health disorders. It works like this: While the acute subjective effects of MDMA are ongoing, patients work with trained practitioners to desensitize to traumatic memories and empathically release maladaptive thoughts. There’s a lot we don’t know, but studies suggest this might work due to the drug’s ability to induce a metaplastic brain state - supercharging the brain’s ability to reorganize, rewire, adapt, and learn in response to new experiences. A huge win for mental health treatment, and more to come! #MentalHealthInnovation #MDMAAssistedTherapy #MAPS

Thrilled to share our 𝐩𝐢𝐥𝐨𝐭 𝐬𝐭𝐮𝐝𝐲 𝐨𝐧 𝐩𝐞𝐫𝐬𝐨𝐧𝐚𝐥𝐢𝐭𝐲 𝐟𝐮𝐧𝐜𝐭𝐢𝐨𝐧𝐢𝐧𝐠! https://lnkd.in/eUkcAyX5 🔍 𝐎𝐛𝐣𝐞𝐜𝐭𝐢𝐯𝐞: We tested a one-week experience sampling method (ESM) protocol to uncover stress-related fluctuations in personality functioning (PF) among outpatients. 📊 𝐑𝐞𝐬𝐮𝐥𝐭𝐬: High compliance and zero adverse events. Our Stress and PF indices displayed excellent consistency and promising validity. We found that a whopping 64% of the variability in PF was due to within-subject differences. Momentary changes in subjective stress and physical activity explained an estimated 46% of this within-subject variance. 🤓 𝐈𝐧𝐭𝐫𝐢𝐠𝐮𝐢𝐧𝐠 𝐟𝐢𝐧𝐝𝐢𝐧𝐠𝐬: The study marks the first-ever glimpse into PF-fluctuations in a clinical sample and explores the link between autonomic nervous system activity and PF in daily life. 💡𝐊𝐞𝐲 𝐓𝐚𝐤𝐞𝐚𝐰𝐚𝐲𝐬: 1.     𝐄𝐯𝐨𝐥𝐮𝐭𝐢𝐨𝐧 𝐢𝐧 𝐏𝐃 𝐦𝐨𝐝𝐞𝐥𝐬: Problems with the validity of PD categories have led to conceptual models that focus on time-related changes and dimensional differences, offering new opportunities to track (and predict?) shifts in PD severity. 2.    𝐒𝐭𝐫𝐞𝐬𝐬 & 𝐩𝐞𝐫𝐬𝐨𝐧𝐚𝐥𝐢𝐭𝐲 𝐟𝐮𝐧𝐜𝐭𝐢𝐨𝐧𝐢𝐧𝐠: This pilot study is the first to show a link between stress and momentary impairments in personality functioning in the daily lives of individuals diagnosed with BPD. 3.    𝐕𝐚𝐥𝐮𝐚𝐛𝐥𝐞 𝐭𝐨𝐨𝐥 𝐟𝐨𝐫 𝐭𝐡𝐞𝐫𝐚𝐩𝐢𝐬𝐭𝐬: We share an easy-to-use ESM questionnaire to explore stress, identity, self-direction, empathy and intimacy in daily life. Definitely worth exploring for therapists specializing in the treatment of PDs. Let's reshape the narrative on (B)PD and enhance therapeutic interventions! Feel free to share your thoughts on our work, and stay tuned for more research. 𝐍𝐞𝐱𝐭 𝐮𝐩: data of our main study in a sample of women diagnosed with BPD (N=50) and a “healthy” sample matched for age (N=50) #innovation #technology #mentalhealth #ehealth

Reflecting on the FDA advisory panel's recent decision regarding Lyko's MDMA-assisted therapy for PTSD, I feel both disappointment and renewed determination. This decision underscores the urgent need for greater education and equitable access to these promising treatments. Despite setbacks, psychedelic research is advancing rapidly. We are on the verge of FDA approval for groundbreaking psychedelic therapeutics that can transform mental health care. I've shared an article I wrote, which remains highly relevant today, addressing the critical barriers we must overcome to ensure the future of psychedelic therapy. Read my article: "Breaking Historic Barriers to Ensure Psychedelic Therapy’s Future" #FDA #PTSD #PsychedelicTherapy #Education #Access #MentalHealth

📢 Join us for SWEET Institute's upcoming seminar on "Psychiatric Medication Management in Individuals with Chronic Medical Conditions"! 📢 🗓 Date: Sunday, August 18th 🕒 Time: 3:00 - 4:00 PM (EST) 📍 Via Zoom This insightful seminar will delve into the complexities of managing psychiatric medications in patients with chronic medical conditions. Our expert speakers will cover: 🔸 Best practices for medication management 🔸 Potential drug interactions and side effects 🔸 Strategies to enhance patient adherence Engage with us! 💬 What challenges have you faced in managing psychiatric medications for patients with chronic conditions? How do you ensure medication adherence in your practice? Share your thoughts and experiences below! Don't miss this opportunity to enhance your knowledge and network with fellow professionals. Reserve your spot now! #PsychiatricCare #MedicationManagement #ChronicConditions #MentalHealth #SWEETInstitute #ContinuingEducation 👉 Register now 👥 Tag a colleague who might be interested! See you there!