Dissociative

Dr. Vince Clinical Research Announces First Dosing in a Phase II Study in Patients With Depression

Retrieved on: 
Wednesday, March 13, 2024
Science, Biotechnology, Research, Pharmaceutical, Health, Mental Health, Professional Services, Clinical Trials, Depression, Brain, Communication, MDD, Partnership, Patient, DSM-IV codes, Clinical trial, Safety, Pharmacology, Phase, Medical director, Dissociative, Pharmaceutical industry

Dr. Vince Clinical Research (DVCR) , a contract research organization (CRO) specializing in early phase trials, announced the first dosing in a Phase II multicenter trial of SPN-820 in adults with major depressive disorder (MDD).

Key Points: 
  • Dr. Vince Clinical Research (DVCR) , a contract research organization (CRO) specializing in early phase trials, announced the first dosing in a Phase II multicenter trial of SPN-820 in adults with major depressive disorder (MDD).
  • MDD is estimated to affect over 17 million adults in the United States, with approximately 30% of these patients being resistant to treatment.
  • Supernus Pharmaceuticals , in collaboration with Navitor Pharmaceuticals , is developing SPN-820 to provide a rapid-onset antidepressant response via oral administration for adult patients with treatment-resistant depression.
  • We are appreciative of the partnership with DVCR for our SPN-820 program.”
    The Phase II study is being conducted at six U.S. sites and is expected to enroll approximately 50 adult MDD patients.

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.

New Pediatric Mental Health Center to Offer Ukraine Children + Teens Free Treatment for War-Related Psychological Trauma

Retrieved on: 
Friday, December 15, 2023
Emotional and behavioral disorders, Psychological abuse, Violence, Depression, Disorder, Anatomical pathology, Atrocity, Anxiety, Psychotherapy, Research, Red Ventures, Uncertainty, St Nicholas Hospital, Fear, Rehabilitation, Partnership, PTSD, Elgin Mental Health Center, Dissociative, Hospital, Stronger Than Ever, Nursing

LVIV, Ukraine, Dec. 15, 2023 /PRNewswire/ -- A groundbreaking new mental health center dedicated to helping Ukraine children and teens suffering PTSD and war trauma-related conditions will open today in Lviv, providing free and low-cost treatment to children in need. The facility, located in Lviv's St. Nicolas Children's Hospital, will provide everything from psychotherapy, speech therapy, rehabilitation and medical services to Ukraine youth. Creation of the center was made possible with a significant investment from nonprofit organization Stronger Than Ever and Red Ventures, a US-based company, along with other donors, through a partnership with Lviv IT Cluster and JustAnswer.

Key Points: 
  • The facility, located in Lviv's St. Nicolas Children's Hospital, will provide everything from psychotherapy, speech therapy, rehabilitation and medical services to Ukraine youth.
  • "The number of children in need of help is increasing every day because the psychological consequences of war are distant in time.
  • "With the pediatric mental health center opening today, we create access to mental health resources for Ukraine's youngest citizens, and empower them to carve a path towards a brighter and more prosperous future for the country."
  • We cannot stand by and watch as a generation of young Ukrainians suffers from the effects of violence and fear."

Silver Hill Hospital Launches Transitional Living Program for the Treatment of Trauma

Retrieved on: 
Monday, November 6, 2023
Managed Care, Hospitals, Health, Mental Health, Tic disorder, Cognitive behavioral therapy, Nightmare, Life, DBT, Medical director, Silver, Treatment, MD, Psychiatry, Dissociative, Fear, Personality, PTSD, Environment, Silver Hill Hospital, Dialectical behavior therapy, Disordered eating, DSM-IV codes, Internet-based treatments for trauma survivors, TLP, CBT, Dissociative disorder, Anxiety, Patient, Diagnosis, Social, Sheppard and Enoch Pratt Hospital, Hospital, Nursing, Trauma

Silver Hill Hospital , one of the nation’s premier psychiatric hospitals, is maintaining its commitment to treating complex psychiatric disorders by launching its new Transitional Living Program (TLP) for the Treatment of Trauma .

Key Points: 
  • Silver Hill Hospital , one of the nation’s premier psychiatric hospitals, is maintaining its commitment to treating complex psychiatric disorders by launching its new Transitional Living Program (TLP) for the Treatment of Trauma .
  • Severe trauma and dissociative disorders require specialized and intensive treatment settings, yet few programs exist, leaving this population highly undertreated.
  • Silver Hill’s Trauma TLP meets the intense demand for effective and safe treatment.
  • She specialized in trauma psychiatry while working at the Trauma Disorders Unit at Sheppard Pratt Hospital, where she served as Co-Service Chief before joining Silver Hill.

Ketabon GmbH Reports Top-Line Results from Phase 2 Trial of Take-at-Home, Oral Ketamine Option for Treatment-Resistant Depression

Retrieved on: 
Monday, August 14, 2023
Blood pressure, Arm, Depression, Czech Republic, Incidence, Dissociative, Patient, Grammatical mood, Psychiatry, Ketamine, Heart rate, TRD, Safety, Pharmaceutical industry, Psychotherapy

MUNICH, Germany, Aug. 14, 2023 (GLOBE NEWSWIRE) -- Ketabon, a joint venture between HMNC Brain Health and Develco Pharma, announced today top-line results from its Phase 2 KET01-02 Ketabon study with lead asset KET01. KET01 is an oral adjunctive treatment featuring a prolonged-release formulation of ketamine and is being studied in patients with treatment-resistant depression (TRD).

Key Points: 
  • KET01 is an oral adjunctive treatment featuring a prolonged-release formulation of ketamine and is being studied in patients with treatment-resistant depression (TRD).
  • KET01, at a 240mg/day dose, demonstrated rapidly occurring, and clinically relevant improvements in depressive severity with statistical significance versus placebo on Day 4 and Day 7.
  • The improvements from baseline were sustained while on active treatment until Day 21, and also after the 4-week follow-up period.
  • “KET01 offers rapid improvement of depressive symptoms while the occurrence of dissociative events interestingly seems to be lower than in currently used ketamine-based treatments.

New Research Finds Dramatic Increase in Illegal Ketamine Seized by Authorities, Sparking Concern About Potential Dangers of Rising Recreational Use

Retrieved on: 
Wednesday, May 24, 2023
Linda, Columbia University, Seizure, Nuffield Department of Population Health, Yale University, Telehealth, Depression, University, GHB, COVID-19, Fear, NYU, Ground substance, New York University Grossman School of Medicine, Research, Heroin, Bangladesh Technical Education Board, Government, NYU Langone Health, Dissociative, Cocaine, National Institute on Drug Abuse, Patient, Risk, Population health, Ketamine, Drug, MPH, Chronic pain, Fentanyl, JAMA Psychiatry, MDMA, Dietary supplement, Pharmaceutical industry, Health, Doctor of Philosophy

"Unlike illegal ketamine years ago, most illegally obtained ketamine today is not pharmaceutical grade and is sold in powder form which may increase the risk that it contains other drugs such as fentanyl."

Key Points: 
  • "Unlike illegal ketamine years ago, most illegally obtained ketamine today is not pharmaceutical grade and is sold in powder form which may increase the risk that it contains other drugs such as fentanyl."
  • He also warns that media and medical promotion of prescription ketamine in recent years is fueling black-market use and availability.
  • NDEWS continues to monitor the use and effects of ketamine and many novel drugs to alert the public about alarming trends in a timely manner.
  • The content of this research is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Vistagen Announces Publication in Cells Demonstrating AV-101’s Potential for Treating Levodopa-Induced Dyskinesia in Patients with Parkinson's Disease

Retrieved on: 
Thursday, November 17, 2022
Mental Health, Health, Neurology, Clinical Trials, Pharmaceutical, Biotechnology, Neuropharmacology, Cell, FDA, Fast Track, Glycine, MDD, LID, Anxiety, PH94B, Brain, Central nervous system disease, Neuropathic pain, Faculty of Pharmacy, University of Lisbon, Patent, NMDA, Université Laval, Dyskinesia, PH10, NMDAR, Parkinson's disease, Patient, L-DOPA, Dissociative, Quality of life, PD, CNS, Research, Faculty, MPTP, CHU, Depression, Risk, Annual report, Therapy, Central nervous system, Neuron, Probenecid, Ketamine, Pharmaceutical industry, Risk management, Pharmacy

While L-Dopa remains the most effective pharmacotherapy for Parkinsons disease, the occurrence of LID is difficult to manage and drastically interferes with Parkinsons patients quality of life.

Key Points: 
  • While L-Dopa remains the most effective pharmacotherapy for Parkinsons disease, the occurrence of LID is difficult to manage and drastically interferes with Parkinsons patients quality of life.
  • This preclinical study showed that AV-101 reduced LID with no adverse effects of treatment, stated Shawn Singh, Chief Executive Officer of Vistagen.
  • Dr. Di Paolo has been at the forefront of research in neuropharmacology and treatments for Parkinsons disease for decades.
  • MPTP is a neurotoxin that kills dopaminergic neurons in the striatum, producing motor symptoms similar to those of PD.

European Medicines Agency Validates Santhera’s Marketing Authorization Application for Vamorolone in Duchenne Muscular Dystrophy

Retrieved on: 
Monday, October 31, 2022
Safety, NINDS, Leber's hereditary optic neuropathy, Vomiting, LHON, JAMA Network Open, Vamorolone, Microdeletion syndrome, EC, Vitamin D deficiency, Cystic fibrosis, CMO, Dissociative, Patient, UK, Time, Foundation, EMA, JAMA, NCATS, Review, JAMA Neurology, Committee for Medicinal Products for Human Use, DMD, European Medicines Agency, Orphan drug, Food and Drug Administration Amendments Act of 2007, Life Science Alliance, CHMP, FDA, National, Defense, National Institutes of Health, Adolescence, Food, PIM, NIAMS, NDA, Muscular dystrophy, Company, Duchenne muscular dystrophy, Union, European Commission, MAA, Vaccine, Pharmaceutical industry, Wood drying, MD, Duchenne

Pratteln, Switzerland, October 31, 2022 Santhera Pharmaceuticals (SIX: SANN) announces that the European Medicines Agency (EMA) has validated its marketing authorization application (MAA) for vamorolone for the treatment of Duchenne muscular dystrophy (DMD).

Key Points: 
  • Pratteln, Switzerland, October 31, 2022 Santhera Pharmaceuticals (SIX: SANN) announces that the European Medicines Agency (EMA) has validated its marketing authorization application (MAA) for vamorolone for the treatment of Duchenne muscular dystrophy (DMD).
  • Subject to EC approval, expected later in 2023, vamorolone will receive marketing authorization in all member states of the European Union, as well as in Norway, Liechtenstein and Iceland.
  • Santhera has submitted a new drug application (NDA) to the U.S. FDA and a marketing authorization application (MAA) to the European Medicines Agency (EMA) for vamorolone for the treatment of DMD.
  • ReveraGen was founded in 2008 to develop first-in-class dissociative steroidal drugs for Duchenne muscular dystrophy and other chronic inflammatory disorders.

Santhera and ReveraGen Complete NDA Submission to FDA for Vamorolone in Duchenne Muscular Dystrophy

Retrieved on: 
Thursday, October 27, 2022
JAMA Neurology, Life expectancy, Union, Muscular dystrophy, PIM, European Medicines Agency, UK, Vamorolone, NINDS, FDA, Dissociative, Ventilation, National Institutes of Health, MAA, Foundation, JAMA Network Open, Inflammation, CEO, Vitamin D deficiency, Food, Patient, Maintenance, Life Science Alliance, Cardiomyopathy, NDA, Heart, Orphan drug, Duchenne muscular dystrophy, Defense, EMA, NIAMS, Company, Weakness, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Doctor of Philosophy, Safety, Disease, LHON, DMD, National, European Commission, Leber's hereditary optic neuropathy, Adolescence, NCATS, Fibrosis, Microdeletion syndrome, Prednisone, Cystic fibrosis, Vomiting, Caregiver, Time, Pharmaceutical industry, Duchenne, MD

Completion of the vamorolone NDA submission is a major step towards our goal of bringing this investigational therapy to patients living with DMD, and represents a vital milestone for Santhera, said Dario Eklund, CEO of Santhera.

Key Points: 
  • Completion of the vamorolone NDA submission is a major step towards our goal of bringing this investigational therapy to patients living with DMD, and represents a vital milestone for Santhera, said Dario Eklund, CEO of Santhera.
  • With the completion of the rolling NDA submission, Santhera and ReveraGen have also applied for priority review.
  • ReveraGen was founded in 2008 to develop first-in-class dissociative steroidal drugs for Duchenne muscular dystrophy and other chronic inflammatory disorders.
  • The development of ReveraGens lead compound, vamorolone, has been supported through partnerships with foundations worldwide, including Muscular Dystrophy Association USA, Parent Project Muscular Dystrophy, Foundation to Eradicate Duchenne, Save Our Sons, JoiningJack, Action Duchenne, CureDuchenne, Ryans Quest, Alexs Wish, DuchenneUK, Pietros Fight, Michaels Cause, Duchenne Research Fund, and Defeat Duchenne Canada.

Santhera and ReveraGen Announce Presentations on Long-Term Efficacy and Bone Health in DMD During Vamorolone Treatment at the 2022 World Muscle Society Congress

Retrieved on: 
Monday, October 10, 2022
National Institutes of Health, Congress, Body mass index, Life Science Alliance, Vamorolone, WMS, Prednisone, NCATS, NINDS, Patient, Muscular dystrophy, JAMA Neurology, Orphan drug, Cystic fibrosis, NIAMS, DMD, UK, Duchenne muscular dystrophy, Adolescence, Company, ADT, LHON, Doctor of Philosophy, Leber's hereditary optic neuropathy, National, Muscle, PIM, Safety, Foundation, Dissociative, FDA, JAMA Network Open, Defense, European Commission, Pharmaceutical industry, Online gambling, Duchenne, MD

Santhera is hosting an on-site scientific exhibit (booth #4, located in the Ballroom Salon) where medical representatives of the Company will be present throughout the conference.

Key Points: 
  • Santhera is hosting an on-site scientific exhibit (booth #4, located in the Ballroom Salon) where medical representatives of the Company will be present throughout the conference.
  • Vamorolone is an investigational medicine and is currently not approved for use by any health authority.
  • ReveraGen was founded in 2008 to develop first-in-class dissociative steroidal drugs for Duchenne muscular dystrophy and other chronic inflammatory disorders.
  • ReveraGen has also received generous support from the US Department of Defense CDMRP, National Institutes of Health (NCATS, NINDS, NIAMS), and European Commission (Horizons 2020).