MADRS

How Psychedelic-Based Therapeutics Are Advancing in Treating Generalized Anxiety Disorder (GAD) Condition

Retrieved on: 
Wednesday, January 24, 2024
Teaching hospital, Research, Anxiety, Life, Benzodiazepine, MADRS, MindMed, NEO, Diagnosis, Depression, Growth, Therapy, Disorder, Psilocybin, Hackensack Meridian Health, Safety, DSM-IV codes, Phase, PALM, GAD, Buspirone, Mental health, PD, University Hospital of Basel, Quality of life, Call-progress tone, CMPS, Patient, Generalized anxiety disorder, Food, HMH, FDA, EU4, Anticonvulsant, DMT, News, Pharmaceutical industry

PALM BEACH, Fla., Jan. 24, 2024 /PRNewswire/ -- The coming years could see a massive shift in the U.S. government's approach to regulating hallucinogenic drugs. Several biopharma companies are developing psychedelics-based treatments for various mental health conditions like Generalized Anxiety Disorder (GAD). GAD is a prevalent mental health condition characterized by excessive and persistent worry, often extending beyond specific triggers. Individuals with GAD experience heightened levels of anxiety, anticipating future events and exhibiting physical symptoms such as muscle tension and restlessness. The disorder significantly impairs daily functioning and quality of life. A report from Delveinsight said that the total market size of the Generalized Anxiety Disorder (GAD) treatment market is anticipated to experience growth during the forecast period (2032) due to the emergence of new and effective treatments, especially numerous trials developing new and innovative next-generation psychedelic treatment options. The report added: "The diagnosis of Generalized Anxiety Disorder (GAD) involves a comprehensive assessment of an individual's mental health, considering the presence of excessive and uncontrollable worry across various aspects of life for a minimum of six months. Clinicians utilize standardized psychiatric interviews and validated screening tools to evaluate the severity of anxiety symptoms, along with a thorough exploration of associated physical and psychological manifestations. Differential diagnosis is crucial to rule out other psychiatric conditions, medical disorders, or substance-related issues that may mimic GAD symptoms. The diagnostic process also entails considering the impact of anxiety on daily functioning and its persistence in the absence of identifiable stressors. A multidimensional approach aids in ensuring an accurate diagnosis and facilitates the development of an effective treatment plan tailored to the individual's needs." Active Companies active today in markets include: Cybin Inc. (NYSE: CYBN) (NEO: CYBN), COMPASS Pathways plc (NASDAQ: CMPS), Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) (NEO: MMED), Seelos Therapeutics, Inc. (NASDAQ: SEEL), atai Life Sciences (NASDAQ: ATAI).

Key Points: 
  • Several biopharma companies are developing psychedelics-based treatments for various mental health conditions like Generalized Anxiety Disorder (GAD).
  • It continued: "DelveInsight's analyst projects that among the total diagnosed prevalent cases of Generalized Anxiety Disorder (GAD) in 7MM approximately 53% of cases were from the US.
  • The Generalized Anxiety Disorder (GAD) market is projected to witness consistent growth throughout the forecast period (2023–2032).
  • The market size of Generalized Anxiety Disorder (GAD) in the 7MM is expected to increase, driven by better diagnosis and the launch of emerging therapies."

How Psychedelic-Based Therapeutics Are Advancing in Treating Generalized Anxiety Disorder (GAD) Condition

Retrieved on: 
Wednesday, January 24, 2024
Teaching hospital, Research, Anxiety, Life, Benzodiazepine, MADRS, MindMed, NEO, Diagnosis, Depression, Growth, Therapy, Disorder, Psilocybin, Hackensack Meridian Health, Safety, DSM-IV codes, Phase, PALM, GAD, Buspirone, Mental health, PD, University Hospital of Basel, Quality of life, Call-progress tone, CMPS, Patient, Generalized anxiety disorder, Food, HMH, FDA, EU4, Anticonvulsant, DMT, News, Pharmaceutical industry

PALM BEACH, Fla., Jan. 24, 2024 /PRNewswire/ -- The coming years could see a massive shift in the U.S. government's approach to regulating hallucinogenic drugs. Several biopharma companies are developing psychedelics-based treatments for various mental health conditions like Generalized Anxiety Disorder (GAD). GAD is a prevalent mental health condition characterized by excessive and persistent worry, often extending beyond specific triggers. Individuals with GAD experience heightened levels of anxiety, anticipating future events and exhibiting physical symptoms such as muscle tension and restlessness. The disorder significantly impairs daily functioning and quality of life. A report from Delveinsight said that the total market size of the Generalized Anxiety Disorder (GAD) treatment market is anticipated to experience growth during the forecast period (2032) due to the emergence of new and effective treatments, especially numerous trials developing new and innovative next-generation psychedelic treatment options. The report added: "The diagnosis of Generalized Anxiety Disorder (GAD) involves a comprehensive assessment of an individual's mental health, considering the presence of excessive and uncontrollable worry across various aspects of life for a minimum of six months. Clinicians utilize standardized psychiatric interviews and validated screening tools to evaluate the severity of anxiety symptoms, along with a thorough exploration of associated physical and psychological manifestations. Differential diagnosis is crucial to rule out other psychiatric conditions, medical disorders, or substance-related issues that may mimic GAD symptoms. The diagnostic process also entails considering the impact of anxiety on daily functioning and its persistence in the absence of identifiable stressors. A multidimensional approach aids in ensuring an accurate diagnosis and facilitates the development of an effective treatment plan tailored to the individual's needs." Active Companies active today in markets include: Cybin Inc. (NYSE: CYBN) (NEO: CYBN), COMPASS Pathways plc (NASDAQ: CMPS), Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) (NEO: MMED), Seelos Therapeutics, Inc. (NASDAQ: SEEL), atai Life Sciences (NASDAQ: ATAI).

Key Points: 
  • Several biopharma companies are developing psychedelics-based treatments for various mental health conditions like Generalized Anxiety Disorder (GAD).
  • It continued: "DelveInsight's analyst projects that among the total diagnosed prevalent cases of Generalized Anxiety Disorder (GAD) in 7MM approximately 53% of cases were from the US.
  • The Generalized Anxiety Disorder (GAD) market is projected to witness consistent growth throughout the forecast period (2023–2032).
  • The market size of Generalized Anxiety Disorder (GAD) in the 7MM is expected to increase, driven by better diagnosis and the launch of emerging therapies."

Human medicines European public assessment report (EPAR): Spravato, esketamine, Date of authorisation: 18/12/2019, Revision: 9, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Blood pressure, Patient, Medical Subject Headings, Marketing, DSM-IV codes, INN, Risk, Rupture, ATC, Depression, System, Bleeding, International, Headache, Nausea, Language, Brain, Dizziness, Vertigo, MADRS, Emotion, European Medicines Agency, Select, Cell, Overalls, Safety, NMDA, Anatomy, Somnolence, SSRI, IIA, SNRI, Dysgeusia, Hypoesthesia, Vomiting, Medical device

Human medicines European public assessment report (EPAR): Spravato, esketamine, Date of authorisation: 18/12/2019, Revision: 9, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Spravato, esketamine, Date of authorisation: 18/12/2019, Revision: 9, Status: Authorised

Sunstone Therapies Announces Publication of Positive Phase 2 Study Results in Cancer

Retrieved on: 
Monday, December 18, 2023
Psilocybin, Clinical trial, Depression, MADRS, Safety, Patient, JAMA Oncology, DSM-IV codes, Pharmaceutical industry

Thirty participants completed the study, with results indicating that psilocybin-assisted therapy in group cohort administration was safe, feasible, and effective.

Key Points: 
  • Thirty participants completed the study, with results indicating that psilocybin-assisted therapy in group cohort administration was safe, feasible, and effective.
  • These results showed that the group approach is feasible and many patients believed it to be of additional benefit.
  • A second study published in Cancer led by Yvan Beaussant, MD, MSc, of Dana-Farber Cancer Institute, gathered information from patients in the trial using exit interviews.
  • Efficient, scalable delivery while maintaining safety is a key issue for psilocybin-assisted therapy and the results of this study suggest a pathway towards wider and faster adoption in the future.”

Study results of psilocybin treatment in bipolar II depression published in JAMA Psychiatry

Retrieved on: 
Wednesday, December 6, 2023
Psychiatry, JAMA Psychiatry, Headache, MD, Therapy, MADRS, Mental health, Annual general meeting, Bipolar II disorder, American College, Safety, Patient, CMPS

Results from the investigator-initiated open-label study were first presented at the Annual Meeting of the American College of Neuropsychopharmacology in 2022.

Key Points: 
  • Results from the investigator-initiated open-label study were first presented at the Annual Meeting of the American College of Neuropsychopharmacology in 2022.
  • The study, which was conducted by Dr Scott Aaronson at Sheppard Pratt, Baltimore, and funded by Compass, investigated the safety and efficacy of a single 25mg dose of COMP360 psilocybin treatment in participants with treatment-resistant bipolar II.
  • The primary endpoint was change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to week 3.
  • “In what we believe to be the first study of its kind, we saw a significant number of patients experience relief from their bipolar II depression symptoms after a single 25mg dose of COMP360 psilocybin treatment.

Intra-Cellular Therapies Highlights Data Presentations at the American College of Neuropsychopharmacology Annual Meeting

Retrieved on: 
Tuesday, December 5, 2023
Neuropsychiatry, Treatment, DSM-IV codes, IND, Grammatical mood, Depression, Prevalence, Literature, Mouse, Human, DSM-5, Cyclothymia, MADRS, Anxiety, Prefrontal cortex, Hallucination, Annual general meeting, Clinical Global Impression, CNS, Social, Poster, American College, Restless, Central nervous system, MDD, Patient, Therapy, Lumateperone, Pharmaceutical industry

NEW YORK, Dec. 05, 2023 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced data presentations at the American College of Neuropsychopharmacology (ACNP) 62nd Annual Meeting.

Key Points: 
  • Company presents preclinical data on ITI-1549, our lead product candidate in our non-hallucinogenic psychedelics program in mood disorders and other psychiatric disorders.
  • NEW YORK, Dec. 05, 2023 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced data presentations at the American College of Neuropsychopharmacology (ACNP) 62nd Annual Meeting.
  • Inner tension is an item within the MADRS which is often used as a surrogate marker for anxiety.
  • The data presented in this poster represent further analyses from Study 403.

Head-to-head Trial of Prolonged-Release Oral Ketamine Formulation, KET01, and Intranasal SPRAVATO®, Finds Less Incidence of Dissociation or Cardiovascular Effects with Oral Treatment, at doses used for Treatment-Resistant Depression

Retrieved on: 
Monday, November 13, 2023
Safety, Incidence, Grammatical mood, Dissociative, Plasma, Headache, Patient, Male, FDA, Treatment-resistant depression, MADRS, TRD, Czech Republic, Esketamine, Ketamine, Dizziness, Pharmaceutical industry, Dietary supplement, Boston

MUNICH, Germany, Nov. 13, 2023 (GLOBE NEWSWIRE) -- Ketabon GmbH (“Ketabon” or “the Company”), a joint venture between HMNC Brain Health and Develco Pharma, announced today favorable results from its head-to-head trial with KET01, the Company’s proprietary lead asset, versus SPRAVATO®, the FDA-approved intranasal spray for patients with Treatment-Resistant Depression (TRD). KET01 is an IP protected oral prolonged-release formulation of ketamine and is being studied in patients with TRD. Due to its unique metabolite profile, the incidence of dissociation with KET01 was very low and statistically significantly lower relative to SPRAVATO®, pointing to a clinically meaningful difference, which could offer the potential for a safe at-home unsupervised administration. During the summer Ketabon also released data from its Phase 2 KET01-02 trial with KET01, which demonstrated rapid and durable improvements in depressive symptoms in TRD. 

Key Points: 
  • KET01 is an IP protected oral prolonged-release formulation of ketamine and is being studied in patients with TRD.
  • During the summer Ketabon also released data from its Phase 2 KET01-02 trial with KET01, which demonstrated rapid and durable improvements in depressive symptoms in TRD.
  • Only minimal signs of dissociative symptoms were detected by the CADSS scale, and no changes in cardiovascular parameters were detected.
  • “Data continues to suggest rapid and clinically relevant reduction of depressive symptoms after oral treatment with 240 mg/day of KET01.

Hedonia: Novel Approach Finds Dramatic Improvement in Depression Scores in Robust Clinical Trial

Retrieved on: 
Wednesday, December 13, 2023
Software, Other Health, General Health, Telemedicine, Virtual Medicine, Biometrics, Mental Health, Apps, Applications, Technology, Medical Devices, Health Technology, Clinical Trials, Biotechnology, Health, Patient Health Questionnaire, Motivation, Waze, Depression, Research, MGH, Randomized controlled trial, Hippocampus, Patient, Samuel, Psychiatry, Anxiety, FTP, MADRS, DSM-IV codes, MD, Harvard Medical School, Diagnosis, Massachusetts General Hospital, Doctor of Philosophy, Mental health, Hospital, Pharmaceutical industry, Nursing, Medical device

This is the first study to use a therapeutic app based on Facilitating Thought ProgressionTM (FTP), a novel approach to mood disorders that disrupts cyclical, repetitive patterns of rigid thinking common in depression and anxiety.

Key Points: 
  • This is the first study to use a therapeutic app based on Facilitating Thought ProgressionTM (FTP), a novel approach to mood disorders that disrupts cyclical, repetitive patterns of rigid thinking common in depression and anxiety.
  • All participants continued their ongoing conventional treatment (medication, therapy, or both), if they were already on any, during the study.
  • On the Montgomery-Asberg Depression Rating Scale (MADRS), a clinician-administered assessment, the depression severity scores of participants in the intervention group dropped by 43%, while the control group’s scores dropped by 18%.
  • The researchers emphasized that this is the first study to examine the delivery of FTP using a mobile application.

Alto Neuroscience Announces Data from Presentations at the 62nd Annual Meeting of the American College of Neuropsychopharmacology

Retrieved on: 
Thursday, December 7, 2023
Mental Health, Technology, Neurology, Clinical Trials, Health Technology, Biotechnology, General Health, Pharmaceutical, Health, Artificial Intelligence, Brain, Schizophrenia, Depression, Electroencephalography, Safety, Deficit spending, Dean (education), Grammatical mood, PD, Clinical trial, Data, Patient, American College, American College of Neuropsychopharmacology, Cross, DSM-IV codes, MADRS, Cognition, Cyclothymia, MD, Harvard Medical School, Translational research, Massachusetts General Hospital, ERP, Neuroscience, EEG, Mental health, Biomarker, MDD, Medical imaging, Phosphorus, Medical device, Pharmaceutical industry, Alto

Alto Neuroscience, Inc. today announced details from three presentations on clinical development programs presented at the 62nd annual meeting of the American College of Neuropsychopharmacology (ACNP) that took place in Tampa, Florida, from December 3-6, 2023.

Key Points: 
  • Alto Neuroscience, Inc. today announced details from three presentations on clinical development programs presented at the 62nd annual meeting of the American College of Neuropsychopharmacology (ACNP) that took place in Tampa, Florida, from December 3-6, 2023.
  • Alto’s data demonstrate advancements in biomarker identification for precision psychiatry and the potential to improve upon the trial-and-error approach to mental health treatment.
  • The company’s AI-enabled Precision Psychiatry Platform™ is designed to predict clinical response and match each patient to the right Alto product candidate through identifying, and prospectively replicating, brain biomarkers by analyzing data generated from EEG activity, neurocognitive task performance, wearable devices, and other measures.
  • Additionally, Alto is advancing ALTO-101 into a Phase 2 proof of concept study in patients with cognitive impairment associated with schizophrenia, with topline data expected in 2025.

Alto Neuroscience Announces Positive Results from Phase 2 Study of ALTO-300 in Major Depressive Disorder

Retrieved on: 
Monday, December 4, 2023
Research, Mental Health, Neurology, Clinical Trials, Health Technology, Biotechnology, General Health, Pharmaceutical, Health, Science, Major depressive disorder, Brain, Depression, Safety, Grammatical mood, Clinical trial, Data, Patient, Medicine, American College, Neuroscience, MADRS, EEG, Biomarker, Alto, MDD, Medical device, Medical imaging

Alto Neuroscience, Inc. today announced positive results from its Phase 2a study of ALTO-300 at the 62nd Annual Meeting of the American College of Neuropsychopharmacology (ACNP), demonstrating clinically meaningful improvements and favorable safety and tolerability in patients with major depressive disorder (MDD).

Key Points: 
  • Alto Neuroscience, Inc. today announced positive results from its Phase 2a study of ALTO-300 at the 62nd Annual Meeting of the American College of Neuropsychopharmacology (ACNP), demonstrating clinically meaningful improvements and favorable safety and tolerability in patients with major depressive disorder (MDD).
  • The company has initiated a Phase 2b study evaluating ALTO-300 in 200 patients with MDD, which is expected to read out in the first half of 2025.
  • Topline results from the ALTO-300 Phase 2a study include:
    A reproducible, readily scalable, and easily administered machine learning-derived EEG biomarker was identified.
  • Alto is leveraging this biomarker and prospective patient identification with EEG in its ongoing Phase 2b trial of ALTO-300.