Treatment-resistant depression

Axsome Therapeutics Confirms Pivotal Status and Advancement of AXS-05 for the Treatment of Alzheimer’s Disease Agitation Based on Successful FDA Breakthrough Therapy Meeting

Retrieved on: 
Monday, August 31, 2020
Health, Psychiatry, Psychiatric diagnosis, Articles, RTT, Antidepressants, Major depressive disorder, Mood disorders, Bupropion/dextromethorphan, Treatment-resistant depression, Breakthrough therapy, Smoking cessation

In June 2020, Axsome received Breakthrough Therapy designation from the FDA for AXS-05 for the treatment of AD agitation, the second Breakthrough Therapy designation received by Axsome for AXS-05.

Key Points: 
  • In June 2020, Axsome received Breakthrough Therapy designation from the FDA for AXS-05 for the treatment of AD agitation, the second Breakthrough Therapy designation received by Axsome for AXS-05.
  • Breakthrough Therapy designation is granted by the FDA in order to expedite the development and review of drugs for serious or life-threatening conditions.
  • Alzheimers disease (AD) is a progressive neurodegenerative disorder characterized by cognitive decline, and behavioral and psychological symptoms including agitation.
  • AXS-05 is being developed for major depressive disorder (MDD), treatment resistant depression (TRD), Alzheimers disease (AD) agitation, and as treatment for smoking cessation.

Treatment-resistant depression (TRD) Market Trends & Epidemiology Forecasts to 2030 - Cariprazine (Allergan/Gedeon Richter) Expected to be Launched in the US Market by 2022 - ResearchAndMarkets.com

Retrieved on: 
Monday, July 13, 2020
Mental health, Health, Psychiatric diagnosis, Psychiatry, Human behavior, Psychology, Drug resistance, Treatment-resistant depression, TRD, Abnormal psychology, Major depressive disorder, Depression

The "Treatment-resistant depression (TRD) - Market Insights, Epidemiology, and Market Forecast - 2030" drug pipelines has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Treatment-resistant depression (TRD) - Market Insights, Epidemiology, and Market Forecast - 2030" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • The total Diagnosed Prevalent population of Treatment-resistant depression (TRD) in 7MM countries was estimated to be 4,464,781 cases in 2017.
  • According to the publisher, Treatment-resistant depression (TRD) market in 7MM is expected to change in the study period 2017-2030.
  • Their opinion helps to understand and validate current and emerging therapies treatment patterns or Treatment-resistant depression (TRD) market trends.

Axsome Therapeutics Completes Successful FDA Pre-NDA Meeting for AXS-05 for the Treatment of Major Depressive Disorder

Retrieved on: 
Monday, July 13, 2020
Antidepressants, Drugs, Branches of biology, Psychoactive drugs, Combination drugs, Depression, Bupropion/dextromethorphan, NMDA receptor antagonists, RTT, Treatment-resistant depression, Major depressive disorder, Management of depression

Axsome received Breakthrough Therapy Designation from the FDA for AXS-05 for the treatment of MDD in March 2019.

Key Points: 
  • Axsome received Breakthrough Therapy Designation from the FDA for AXS-05 for the treatment of MDD in March 2019.
  • Axsome is pleased with the outcome of our recent pre-NDA meeting with the FDA, which confirmed the studies and data to be presented in our planned NDA submission of AXS-05 in major depressive disorder, said Herriot Tabuteau, MD, Chief Executive Officer of Axsome.
  • If approved, AXS-05 has the potential to be the first oral, NMDA receptor antagonist for the treatment of depression.
  • AXS-05 is being developed for major depressive disorder (MDD), treatment resistant depression (TRD), Alzheimers disease (AD) agitation, and as treatment for smoking cessation.

LivaNova Announces Publication Detailing the Design of the RECOVER Clinical Study Evaluating VNS Therapy for Treatment-Resistant Depression

Retrieved on: 
Tuesday, July 7, 2020
Cardiology, Biotechnology, FDA, Health, Mental health, Medical devices, Research, Hospitals, Surgery, Science, Clinical trials, Branches of biology, Neuroscience, Medicine, Neurophysiology, Depression, Neurotechnology, Drug resistance, Neuromodulation, Treatment-resistant depression, LivaNova, Major depressive disorder, Clinical trial

Working with CMS, we designed RECOVER the largest clinical study of its kind to further evaluate and confirm the efficacy of VNS Therapy for TRD, said Bryan Olin, LivaNova Senior Vice President for Clinical, Quality and Regulatory Affairs.

Key Points: 
  • Working with CMS, we designed RECOVER the largest clinical study of its kind to further evaluate and confirm the efficacy of VNS Therapy for TRD, said Bryan Olin, LivaNova Senior Vice President for Clinical, Quality and Regulatory Affairs.
  • More information about the RECOVER study is available at ClinicalTrials.gov and at recovervns .com.
  • LivaNova operates as two businesses: Cardiovascular and Neuromodulation, with operating headquarters in Mirandola (Italy) and Houston (U.S.), respectively.
  • These statements include, but are not limited to, statements regarding VNS Therapy and our approach to treatment-resistant depression using VNS Therapy.

Axsome Therapeutics Presents Data from GEMINI Phase 3 Trial of AXS-05 in Major Depressive Disorder at the 2020 American Society for Clinical Psychopharmacology Annual Meeting

Retrieved on: 
Friday, May 29, 2020
Psychoactive drugs, Drugs, Antidepressants, RTT, Nicotinic antagonists, Depression, Combination drugs, Bupropion/dextromethorphan, Bupropion, Treatment-resistant depression, Dextromethorphan, Smoking cessation

AXS-05 consists of a proprietary formulation and dose of dextromethorphan and bupropion and utilizes Axsomes metabolic inhibition technology.

Key Points: 
  • AXS-05 consists of a proprietary formulation and dose of dextromethorphan and bupropion and utilizes Axsomes metabolic inhibition technology.
  • For the many people facing unsatisfactory treatments for CNS disorders, Axsome accelerates the invention and adoption of life-changing medicines.
  • AXS-05 is being developed for major depressive disorder (MDD), treatment resistant depression (TRD), Alzheimers disease (AD) agitation, and as treatment for smoking cessation.
  • The data disclosed in this press release are considered topline data and subject to further statistical review and the final results may vary.

Nexstim Reports Promising Clinical Outcomes of First 55 Patients Completing SmartFocus® rTMS Treatment of Major Depressive Disorder

Retrieved on: 
Friday, April 17, 2020
Medicine, Psychiatry, Branches of biology, Depression, Clinical research, Medical statistics, RTT, Mood disorders, Transcranial magnetic stimulation, Major depressive disorder, Clinical endpoint, Treatment-resistant depression

Nexstim Plc (NXTMH:HEX, NXTMS:STO) ("Nexstim" or "Company") reports the clinical outcomes of the first 55 patients who have completed SmartFocus rTMS therapy for treatment of major depressive disorder (MDD) at clinical sites in the United States.

Key Points: 
  • Nexstim Plc (NXTMH:HEX, NXTMS:STO) ("Nexstim" or "Company") reports the clinical outcomes of the first 55 patients who have completed SmartFocus rTMS therapy for treatment of major depressive disorder (MDD) at clinical sites in the United States.
  • 40% of the patients completing the treatment achieved clinical remission and 71% obtained a clinical response at the end of treatment.
  • The clinical outcomes of SmartFocus rTMS treated patients are being collected in a registry the information is provided by participating clinical sites using Nexstims SmartFocus technology.
  • Mikko Karvinen, CEO of Nexstim Plc said: We are happy to report these promising clinical outcomes based on the data registry.

Axsome Therapeutics Announces Topline Results of the STRIDE-1 Phase 3 Trial in Treatment Resistant Depression and Expert Call to Discuss Clinical Implications

Retrieved on: 
Monday, March 30, 2020
Antidepressants, Depression, Drugs, Medicine, Clinical medicine, Combination drugs, Bupropion/dextromethorphan, Mood disorders, Psychiatric diagnosis, Treatment-resistant depression, Major depressive disorder, TRD

These data suggest that AXS-05 may represent a novel approach both for the frontline treatment of major depressive disorder, and for treatment resistant depression.

Key Points: 
  • These data suggest that AXS-05 may represent a novel approach both for the frontline treatment of major depressive disorder, and for treatment resistant depression.
  • Based on the results of the STRIDE-1 trial, Axsome intends to initiate a second Phase 3 trial of AXS-05 in patients with treatment resistant depression in the third quarter of 2020.
  • Axsome will host a conference call and webcast with slides today at 8:00 AM Eastern to discuss the topline results of the STRIDE-1 trial of AXS-05 in treatment resistant depression.
  • STRIDE-1 (Symptom Treatment in Resistant Depression 1) was a Phase 3, randomized, double-blind, active controlled trial to assess the efficacy and safety of AXS-05 in the treatment of treatment resistant depression (TRD).

Axsome Therapeutics Accelerates Completion of the ADVANCE-1 Phase 2/3 Trial of AXS-05 in Alzheimer’s Disease Agitation

Retrieved on: 
Friday, March 20, 2020
Psychiatry, RTT, Psychiatric diagnosis, Medicine, Antidepressants, Cognitive disorders, Learning disabilities, Health, Bupropion/dextromethorphan, Alzheimer's disease, Dementia, Treatment-resistant depression

The ADVANCE-1 trial is enrolling only patients 65 years of age or older, the demographic at highest risk for COVID-19 related fatalities.

Key Points: 
  • The ADVANCE-1 trial is enrolling only patients 65 years of age or older, the demographic at highest risk for COVID-19 related fatalities.
  • ADVANCE-1 (Addressing Dementia Via Agitation-Centered Evaluation 1) is a Phase 2/3 multicenter, randomized, double-blind, controlled trial to evaluate the efficacy and safety of AXS-05 in patients with agitation associated with Alzheimers disease.
  • Alzheimers disease (AD) is a progressive neurodegenerative disorder that manifests initially as forgetfulness advancing to severe cognitive impairment and memory loss.
  • AXS-05 is currently in a Phase 3 trial in treatment resistant depression (TRD), a Phase 2/3 trial in agitation associated with Alzheimers disease (AD), and is being developed for major depressive disorder (MDD).

D'Amore Healthcare Offers Ketamine Therapy

Retrieved on: 
Monday, March 9, 2020
Psychoactive drugs, Drugs, Neurochemistry, Antidepressants, NMDA receptor antagonists, Sedatives, Amines, Nicotinic antagonists, Ketamine, Esketamine, Management of depression, Treatment-resistant depression

"Spravato" is the latest technique being utilized to counteract treatment-resistant depression.Spravato is a variation of Ketamine Therapy that is administered in a nasal spray as opposed to previous intravenous ketamine infusions.

Key Points: 
  • "Spravato" is the latest technique being utilized to counteract treatment-resistant depression.Spravato is a variation of Ketamine Therapy that is administered in a nasal spray as opposed to previous intravenous ketamine infusions.
  • With tremendous support, Ketamine therapy was approved by the Food and Drug Administration for the treatment of depression in March of 2019.
  • D'Amore Healthcare recently became licensed to administer Ketamine Therapy in the less-invasive form of a nasal spray called Spravato.
  • At their Huntington Beach Treatment Center, D'Amore provides Ketamine Therapy that is overseen by trained medical professionals.

2019 Global Treatment Resistant Depression Clinical Trials Review, H2: Overview of Trial Numbers & their Average Enrollment in Top Countries Conducted Across the Globe - ResearchAndMarkets.com

Retrieved on: 
Thursday, January 30, 2020
Pharmaceutical, Health, Clinical trials, Mental health, Health, Clinical research, Medical research, Depression, Pharmaceutical industry, Food and Drug Administration, Design of experiments, Treatment-resistant depression, Major depressive disorder, Clinical trials

The "Treatment Resistant Depression Global Clinical Trials Review, H2, 2019" clinical trials has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Treatment Resistant Depression Global Clinical Trials Review, H2, 2019" clinical trials has been added to ResearchAndMarkets.com's offering.
  • The clinical trial report, Treatment Resistant Depression Global Clinical Trials Review, H2, 2019 provides an overview of Treatment Resistant Depression clinical trials scenario.
  • This report provides top line data relating to the clinical trials on Treatment Resistant Depression.
  • Clinical trials are collated from 80+ different clinical trial registries, conferences, journals, news etc across the globe.