Major depressive disorder

ABVC BioPharma Provides ABV-1601 Update on Phase I Site Initiation Visit Conducted at Cedars-Sinai Medical Center (CSMC)

Retrieved on: 
Monday, April 10, 2023
Major depressive disorder, Depression, Montgomery–Åsberg Depression Rating Scale, SIV, Brand, Cancer, Cedars-Sinai Medical Center, Medicine, MADRS, CNS, Trial of the century, SAE, MDD, Patient, Ophthalmology, Grammatical mood, Bupropion, CSMC, Phase, ITT, Safety, Pharmaceutical industry

The SIV was an organized meeting to discuss Phase I study protocol with the principal investigator, Scott A. Irwin, M.D., Ph.D. and begin training clinical personnel.

Key Points: 
  • The SIV was an organized meeting to discuss Phase I study protocol with the principal investigator, Scott A. Irwin, M.D., Ph.D. and begin training clinical personnel.
  • ABV-1601, the Phase I open-label study will be conducted with 12 cancer patients with moderate to severe depressive symptoms.
  • The main objective of the study is to evaluate the safety of PDC-1421, the primary active ingredient in ABV-1601, in cancer patients.
  • “We are pleased to see the ABV-1601 Site Initiation Visit successfully completed at Cedars-Sinai Medical Center (CSMC) with Dr. Scott Irwin M.D., Ph.D. and his clinical team,” said Dr. Howard Doong, Chief Executive Officer of the Company.

Small Pharma Announces Positive Six-month Data from Phase IIa Trial of SPL026

Retrieved on: 
Tuesday, April 4, 2023
Chief scientific officer, DMT, Weill Institute for Cell and Molecular Biology, Depression, University, University of California, San Francisco, Neuroimaging, MDD, Patient, The Retreat, Psychiatry, Behavioural sciences, Phase, Safety, Major depressive disorder, Pharmaceutical industry, N, Neurology

LONDON, April 04, 2023 (GLOBE NEWSWIRE) -- Small Pharma Inc. (TSXV: DMT) (OTCQB: DMTTF) (the “Company” or “Small Pharma”), a biotechnology company focused on short-duration psychedelic-assisted therapies for mental health conditions, today announces positive six-month data from the Company’s Phase IIa clinical trial of SPL026.

Key Points: 
  • LONDON, April 04, 2023 (GLOBE NEWSWIRE) -- Small Pharma Inc. (TSXV: DMT) (OTCQB: DMTTF) (the “Company” or “Small Pharma”), a biotechnology company focused on short-duration psychedelic-assisted therapies for mental health conditions, today announces positive six-month data from the Company’s Phase IIa clinical trial of SPL026.
  • New data from the Phase IIa trial shows that among the patients who had achieved remission within three months with SPL026, 64% sustained remission to six months.
  • The trial investigated the efficacy and safety of 21.5mg intravenous (“IV”) SPL026 with supportive therapy in 34 patients with moderate/severe MDD.
  • Dr. Carol Routledge, Chief Medical & Scientific Officer said: “With our ongoing analyses of the Phase IIa trial data, we are increasingly encouraged by the treatment potential of SPL026.

Red Cell Partners Announces $3 Million in Pre-Seed Funding for Psychedelic Company TARA Mind

Retrieved on: 
Thursday, April 13, 2023
Pharmaceutical, Health, Neurology, Mental Health, Red Cell, Partnership, Depression, Icahn School of Medicine at Mount Sinai, Suicide, Integration, Absenteeism, Professional corporation, Health equity, Veteran, Human, Multimedia, Harvard Medical School, Mount Sinai, Doctor of Philosophy, Science, Stanford University School of Medicine, MDD, MD, Post-traumatic stress disorder, Standard of care, Mental, Navy, Traumatic brain injury, Behavioural sciences, PAT, Entrepreneurship, ROI, TRD, Death, Mental health, Society, Fourth Estate Public Benefit Corporation, Safety, Major depressive disorder, Pharmaceutical industry, Nursing, Psychotherapy, Medicine, Trauma, Practitioner, Psychiatry

Red Cell Partners, an incubation firm building and investing in technology-led companies that bring revolutionary advancements to healthcare and national security, has announced $3 million in pre-seed funding for TARA Mind, a mental health company that enables safe and affordable access to psychedelic-assisted therapy (PAT).

Key Points: 
  • Red Cell Partners, an incubation firm building and investing in technology-led companies that bring revolutionary advancements to healthcare and national security, has announced $3 million in pre-seed funding for TARA Mind, a mental health company that enables safe and affordable access to psychedelic-assisted therapy (PAT).
  • The problem is a large and complicated one exacerbated by misaligned incentives, a global pandemic, and deep-rooted stigma surrounding psychedelics and other alternative therapies.
  • “Far too many people are being failed by our country’s outdated approach to mental health care,” said Red Cell CEO and TARA Mind Co-Founder, Grant Verstandig.
  • At TARA Mind, we aren’t being guided by ‘the buzz’ around psychedelics, nor are we chasing a quick profit from lingering loopholes in a post-COVID world.

Evecxia Therapeutics Reports Favorable Data From a Phase 1 Single-Ascending Dose and Multiple-Ascending Dose Trial of Adjunctive EVX-101 in Healthy Volunteers Treated With a First-Line Antidepressant

Retrieved on: 
Monday, April 10, 2023
Men, Research, General Health, Family, Pharmaceutical, Consumer, Mental Health, Clinical Trials, Science, Biotechnology, Women, Health, Other Science, Quotient, PK, Major depressive disorder, Depression, Safety, SAD, Harvard Medical School, Plasma, MDD, Vital signs, Patient, Carbidopa, 5-Hydroxytryptophan, Pharmacokinetics, BID, Psychiatry, Grammatical mood, MAD, SNRI, Serotonin, SATRO-ECG, Massachusetts General Hospital, Therapy, SSRI, Pharmacology, Pharmaceutical industry, Medicinal plants

Evecxia Therapeutics, Inc. today announced favorable safety, tolerability, pharmacokinetic, and pharmacodynamic data from a double-blind, placebo-controlled Phase 1, a two-part single ascending dose (SAD) and multiple ascending dose (MAD) trial of EVX-101 in healthy volunteers treated with escitalopram.

Key Points: 
  • Evecxia Therapeutics, Inc. today announced favorable safety, tolerability, pharmacokinetic, and pharmacodynamic data from a double-blind, placebo-controlled Phase 1, a two-part single ascending dose (SAD) and multiple ascending dose (MAD) trial of EVX-101 in healthy volunteers treated with escitalopram.
  • In EVX-101, the 5-HTP dose is fixed at 250 mg, while variable levels of carbidopa control 5-HTP plasma exposure levels.
  • Thirty-four healthy subjects were randomized to EVX-101 twice-daily (BID) or placebo in the Phase 1 SAD-MAD trial (EVX-101 N=25, Placebo N=9).
  • Best practices will be employed to ensure the quality and integrity of the EVX-101 Phase 2 trial.

Beckley Psytech initiates Phase IIa study of 5-MeO-DMT candidate BPL-003 for Alcohol Use Disorder

Retrieved on: 
Wednesday, April 5, 2023
Biotechnology, Technology, Health, Pharmaceutical, Mental Health, Health Technology, Other Technology, Medical Devices, Research, Science, Clinical Trials, Drug development, Phases of clinical research, Beckley Foundation, Pharmacokinetics, King's College London, DSM-IV codes, University College London Hospitals NHS Foundation Trust, Death, AUD, MDD, Patient, Atypical depression, King, FDA, TRD, Treatment, Safety, Major depressive disorder, Pharmaceutical industry

Beckley Psytech Ltd, a private, clinical-stage biotechnology company dedicated to addressing neuropsychiatric disorders by transforming psychedelics into effective and licensed medicines, today announced that it has initiated a Phase IIa study ( NCT05674929 ) investigating its lead candidate, BPL-003, as a potential treatment for alcohol use disorder (AUD).

Key Points: 
  • Beckley Psytech Ltd, a private, clinical-stage biotechnology company dedicated to addressing neuropsychiatric disorders by transforming psychedelics into effective and licensed medicines, today announced that it has initiated a Phase IIa study ( NCT05674929 ) investigating its lead candidate, BPL-003, as a potential treatment for alcohol use disorder (AUD).
  • Beckley Psytech’s Phase IIa study, taking place at King’s College Hospital in London, will explore the safety, efficacy and pharmacokinetics of BPL-003 in patients diagnosed with alcohol use disorder (AUD).
  • Alcohol use disorders are estimated to affect around 237 million people across the globe , with 3 million deaths each year attributed to the harmful use of alcohol.
  • Cosmo Feilding Mellen, CEO of Beckley Psytech, said: “There is increasing evidence demonstrating the therapeutic effect of psychedelics for substance use disorders.

Alzamend Neuro Announces the Initiation of a Phase I/IIA Trial for Its Immunotherapy Vaccine (ALZN002) to Treat Mild to Moderate Dementia of the Alzheimer’s Type

Retrieved on: 
Monday, April 3, 2023
Mental Health, Research, Neurology, Clinical Trials, Biotechnology, Health, Pharmaceutical, Other Science, Science, Major depressive disorder, IIA, Clinical trial, Dementia, Post-traumatic stress disorder, Patient, Immune system, Disease, Bipolar disorder, Safety, Pharmaceutical industry

Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), an early clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s disease (“Alzheimer’s”), bipolar disorder, major depressive disorder (“MDD”) and post-traumatic stress disorder (“PTSD”), today announced the initiation of a phase I/IIA clinical trial for its immunotherapy vaccine (ALZN002) to treat mild to moderate dementia of the Alzheimer’s type.

Key Points: 
  • Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), an early clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s disease (“Alzheimer’s”), bipolar disorder, major depressive disorder (“MDD”) and post-traumatic stress disorder (“PTSD”), today announced the initiation of a phase I/IIA clinical trial for its immunotherapy vaccine (ALZN002) to treat mild to moderate dementia of the Alzheimer’s type.
  • The purpose of this trial is to assess the safety, tolerability, and efficacy of multiple ascending doses of ALZN002 compared with that of placebo in 20-30 subjects with mild to moderate morbidity.
  • The primary goal of this clinical trial is to determine an appropriate dose of ALZN002 for treatment of patients with Alzheimer’s in a larger Phase IIB efficacy and safety clinical trial, which Alzamend expects to initiate within three months of receiving data from the initial trial.
  • Today, we are on the threshold of importantly advancing the art and science of anti-beta amyloid therapy by treating each Alzheimer’s patient’s individual immune system,” said Stephan Jackman, Chief Executive Officer of Alzamend.

Best Poster Awardees Announced at AMCP 2023 Focus on Adherence

Retrieved on: 
Friday, April 7, 2023
Anticoagulant, Medicine, CAE, Doctor of Pharmacy, University, Atrial fibrillation, Evidence-based medicine, AMCP, Master of Philosophy, Health, MBA, Research, Doctor of Philosophy, DOAC, Medicare, Graduate, PDC, DSM-IV codes, MDD, Patient, Population health, University of Houston, Prevalence, Jefferson College, Ageing, CVS Health, Medication, Female, Major depressive disorder, Nursing

ALEXANDRIA, Va., April 7, 2023 /PRNewswire/ -- AMCP Foundation and CVS Health announced the recipients of AMCP Foundation's Best Poster Awards at AMCP 2023.

Key Points: 
  • ALEXANDRIA, Va., April 7, 2023 /PRNewswire/ -- AMCP Foundation and CVS Health announced the recipients of AMCP Foundation's Best Poster Awards at AMCP 2023.
  • Since 2002, AMCP Foundation's Best Poster Competition has allowed student pharmacists and new practitioners to demonstrate analytic proficiency, poster development, and technical skills.
  • AMCP Foundation also periodically invites established researchers to compete for topical Best Poster Awards.
  • The Best Poster Awards at AMCP 2023 were made possible by funding partner CVS Health, the Journal of Managed Care & Specialty Pharmacy, the Best Poster judges, and research preceptors who support AMCP Foundation's efforts to recognize future pharmacists and new practitioners conducting transformative research.

Nexalin Technology Provides 2022 Year-End Business Update

Retrieved on: 
Monday, March 27, 2023
Initial public offering, Depression, University, File, Second generation, Anxiety, Central South University, University of California, San Diego Performance-Based Skills Assessment, Brain, TBI, Insomnia, Hospital, PMA, MDD, Patient, Investment, Traumatic brain injury, Algorithm, Security (finance), United, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Safety, Chronic pain, NMPA, Food, PTSD, Major depressive disorder, Cryptocurrency, Pharmaceutical industry

HOUSTON, March 27, 2023 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (the “Company” or “Nexalin”) (Nasdaq: NXL; NXLIW) today provided a business update for the year ended December 31, 2022.

Key Points: 
  • HOUSTON, March 27, 2023 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (the “Company” or “Nexalin”) (Nasdaq: NXL; NXLIW) today provided a business update for the year ended December 31, 2022.
  • Mark White, CEO of Nexalin Technology stated, “Nexalin has made significant progress towards commencing clinical trials of our Gen-2 and Gen-3 neurostimulation devices in the United States.
  • As of December 31, 2022, we had cash, cash equivalents and short-term investments of $7.0 million, which we believe provides us sufficient liquidity to execute our business plan.
  • The increase in revenue for 2022 compared to 2021 was primarily due to increased device sales in 2022.

Alzamend Neuro Announces Completion of Clinical Portion of Phase IIA Multiple Ascending Dose Clinical Trial for AL001 Treatment of Dementia Related to Alzheimer’s

Retrieved on: 
Wednesday, March 22, 2023
Biotechnology, Mental Health, Health, Pharmaceutical, Clinical Trials, Major depressive disorder, IIA, Deficit spending, Dementia, MDD, Post-traumatic stress disorder, Patient, MAD, Lithium toxicity, Bipolar disorder, PTSD, Safety, Lithium, Pharmaceutical industry

Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), an early clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s disease (“Alzheimer’s”), bipolar disorder, major depressive disorder (“MDD”) and post-traumatic stress disorder (“PTSD”), today announced the completion of the clinical portion of its Phase IIA multiple ascending dose (“MAD”) study for dementia related to Alzheimer’s.

Key Points: 
  • Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), an early clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s disease (“Alzheimer’s”), bipolar disorder, major depressive disorder (“MDD”) and post-traumatic stress disorder (“PTSD”), today announced the completion of the clinical portion of its Phase IIA multiple ascending dose (“MAD”) study for dementia related to Alzheimer’s.
  • The MAD study’s purpose was to evaluate the safety and tolerability of AL001 under multiple-dose, steady-state conditions and determine the maximum tolerated dose in patients diagnosed with mild to moderate Alzheimer’s and healthy subjects.
  • AL001 has the potential to deliver benefits of marketed lithium carbonate while mitigating or avoiding current toxicities associated with lithium.
  • “We look forward to reporting topline data in June 2023 and further advancing clinical development of this promising potential therapeutic.”

FSD Pharma Announces Its Australian Entity Receives Approval to Proceed With Phase 1 Clinical Trial of Lucid-201, a Candidate for the Potential Treatment of Major Depressive Disorder

Retrieved on: 
Wednesday, March 22, 2023
Science, Neurology, Biotechnology, Research, Pharmaceutical, Health, Mental Health, Clinical Trials, CSE, Depression, Therapy, FSD, DSM-IV codes, Grammatical mood, Seasonal affective disorder, SAD, Multiple sclerosis, FRA, Sadness, Anhedonia, MDD, Season, Machine learning, Melancholic depression, Algorithm, Psychotic depression, Motivation, Ageing, United, National Institute for Health and Care Excellence, Major depressive disorder, Pharmaceutical industry

Hundreds of millions of people globally need new, safer, accessible and more effective options to redefine the front-line approach by getting to the root of the disorder and how it is currently treated.

Key Points: 
  • Hundreds of millions of people globally need new, safer, accessible and more effective options to redefine the front-line approach by getting to the root of the disorder and how it is currently treated.
  • MDD can be a chronic condition with multiple periods of regression and relapse over a lifetime.
  • Different types of MDD include Seasonal Affective Disorder (SAD), Postpartum depression, psychotic depression, melancholic depression, and catatonic depression.
  • According to Allied Market Research, the global antidepressant drugs market size was valued at $15.65 billion in 2020 and is projected to reach $21.0 billion by 2030.2