Major depressive disorder

Tonix Pharmaceuticals Announces Topline Results from Phase 2 Proof-of-Concept Study of TNX-601 ER for the Treatment of Major Depressive Disorder

Retrieved on: 
Tuesday, October 31, 2023

CHATHAM, N.J., Oct. 31, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced topline results from the Phase 2 proof-of-concept double-blind, randomized, multi-center, placebo-controlled UPLIFT study of TNX-601 ER* (tianeptine hemioxalate extended-release tablets) in patients with major depressive disorder (MDD). The primary efficacy endpoint of change from baseline in depression severity, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) total score, did not achieve clinical or statistical significance.

Key Points: 
  • The primary efficacy endpoint of change from baseline in depression severity, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) total score, did not achieve clinical or statistical significance.
  • “Based on these efficacy results, we are discontinuing development of TNX-601 ER.
  • We look forward to topline results from our Phase 2 study of TNX-1900 in chronic migraine in early December and topline results from our Phase 3 potential NDA-enabling study of TNX-102 SL in fibromyalgia in late December,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals.
  • In the study, TNX-601 ER was generally well-tolerated with a favorable safety profile.

Researchers at Fermata to Study SAINT Neuromodulation for Treatment-Resistant Major Depression

Retrieved on: 
Wednesday, October 25, 2023

The prospective, multi-site open-label optimization study (OLO) is designed to further evaluate the effectiveness of the investigational SAINT Neuromodulation System for the treatment of adults with MDD.

Key Points: 
  • The prospective, multi-site open-label optimization study (OLO) is designed to further evaluate the effectiveness of the investigational SAINT Neuromodulation System for the treatment of adults with MDD.
  • The SAINT Neuromodulation System may yield a new form of personalized, focused neurostimulation in adults with major depression.
  • Treatment-resistant depression (TRD) can leave sufferers feeling like they are out of options," said Owen Scott Muir, M.D.
  • This study is the first time the SAINT Neuromodulation System has been studied at multiple sites in a large sample of individuals with major depression.

ABVC BioPharma Receives Taiwanese Patent for Its Treatment of Major Depressive Disorder (MDD)

Retrieved on: 
Monday, October 9, 2023

FREMONT, CA, Oct. 09, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire -- ABVC BioPharma, Inc. (NASDAQ: ABVC) ("Company"), a clinical-stage biopharmaceutical company developing therapeutic solutions in ophthalmology, neurology, and oncology/hematology, announced today that it received a Taiwanese patent, Application No. 109130285, for the use of PDC-1421, a Radix Polygala (Polygala tenuifolia Willd) extract, which is used in the Company’s asset ABV-1504 for the treatment of Major Depressive Disorder (MDD). The Company was previously awarded a U.S. patent, US 11,554,154 B2, on April 25, 2023, for the same treatment.

Key Points: 
  • 109130285, for the use of PDC-1421, a Radix Polygala (Polygala tenuifolia Willd) extract, which is used in the Company’s asset ABV-1504 for the treatment of Major Depressive Disorder (MDD).
  • The Company was previously awarded a U.S. patent, US 11,554,154 B2, on April 25, 2023, for the same treatment.
  • The patent application was submitted to the Taiwan Patent and Trademark Office under the title "Polygala Extract for the Treatment of Major Depressive Disorder."
  • The invention relates to oral administration of the formulation containing a Radix Polygala (Polygala tenuifolia Willd) extract, PDC-1421, as a capsule for treating Major Depressive Disorder.

I think my teen is depressed. How can I get them help and what are the treatment options?

Retrieved on: 
Wednesday, October 4, 2023

And young people may say they feel so “depressed” about upcoming exams, or that the world is “just so depressing” these days.

Key Points: 
  • And young people may say they feel so “depressed” about upcoming exams, or that the world is “just so depressing” these days.
  • But how do you know if your teen is experiencing what health professionals call “major depression”?
  • Major depression is characterised by persistent low mood and/or irritability and loss of interest or pleasure in usual activities for at least two weeks.

Increasing over time

    • There is evidence depression is increasing among young people, with an international study in 2021 estimating 25% of children and adolescents experienced elevated depression symptoms – double pre-pandemic levels.
    • Given the understandable distress experienced by many young people, how can parents or carers know when to seek help?

Listen up

    • Let them know you have noticed some changes and you are concerned about them.
    • If your child opens up about their difficulties, listen carefully and validate their feelings.
    • Being able to talk about difficulties, and knowing support is there if they need may be enough for some teens.

Start with a GP

    • The first step to finding appropriate treatment will likely be supporting your teen to see a GP.
    • The GP may refer them to a mental health professional, such as a psychologist or psychiatrist.

What does depression treatment look like?


    A recent review on recognising and managing teen depression examined clinical practice guidelines from Canada, Australia, the United Kingdom, the United States and New Zealand found a comprehensive treatment approach is typically used. Treatment can include:
    • They are typically used in cases of severe depression, or if psychological treatments have been unsuccessful.
    • However, untreated depression is also a risk factor for suicide, so the potential benefits and risks of antidepressant use by teens needs to be carefully considered.

Assessing risk

    • Suicide risk assessment is a critical part of any treatment for depression, and should include the development of a safety plan with the teen and their parents or carers.
    • Safety plans can be very helpful in times of distress, listing helpful coping strategies and contact details for family, friends and health professionals.
    • If you are concerned your teen might be at risk of suicide, take it seriously.
    • Louise Birrell receives funding from the National Health and Medical Research Council, the Australian government and Australian Rotary Health.
    • She receives funding from the National Health and Medical Research Council, the Australian Government, BHP Foundation, Paul Ramsay Foundation and other research organisations.

Small Pharma Reports Positive Top-line Data from SPL026 (DMT)-SSRI Drug Interaction Study in Patients with Major Depressive Disorder

Retrieved on: 
Wednesday, September 27, 2023

This is impressive especially when combined with previously reported Phase IIa SPL026 efficacy data in MDD showing a rapid antidepressant effect and sustained remission to six months.

Key Points: 
  • This is impressive especially when combined with previously reported Phase IIa SPL026 efficacy data in MDD showing a rapid antidepressant effect and sustained remission to six months.
  • In the Phase I/IIa SPL026 study, patients were required to be withdrawn from SSRIs, which can be a disruptive experience.
  • Through the SPL026-SSRI drug interaction study, Small Pharma aimed to address this requirement, which could enable broader patient recruitment on future large-scale studies, and potentially accelerate the clinical development pathway.
  • Efficacy was assessed using the Montgomery-Asberg Depression Rating scale (MADRS) to measure any change in patients’ depression symptoms from baseline.

Small Pharma Reports Positive Top-line Data from SPL026 (DMT)-SSRI Drug Interaction Study in Patients with Major Depressive Disorder

Retrieved on: 
Tuesday, September 26, 2023

LONDON, Sept. 26, 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 safety, tolerability and efficacy data from its Phase Ib study exploring the interaction between selective serotonin reuptake inhibitors (“SSRIs”) and SPL026, native N, N-dimethyltryptamine (“DMT”), in patients with Major Depressive Disorder (“MDD”).

Key Points: 
  • In the Phase I/IIa SPL026 study, patients were required to be withdrawn from SSRIs, which can be a disruptive experience.
  • Through the SPL026-SSRI drug interaction study, Small Pharma aimed to address this requirement, which could enable broader patient recruitment on future large-scale studies, and potentially accelerate the clinical development pathway.
  • Additionally, removing the requirement to be withdrawn from SSRIs may facilitate patient access to SPL026 earlier in the MDD treatment journey, if approved.
  • Efficacy was assessed using the Montgomery-Asberg Depression Rating scale (MADRS) to measure any change in patients’ depression symptoms from baseline.

Seelos Therapeutics Announces Top Line Results from SLS-002 Phase II Study in Adults with Major Depressive Disorder at Imminent Risk of Suicide

Retrieved on: 
Wednesday, September 20, 2023

The graph presents results from the mixed model for repeated measures (MMRM) analysis of change from baseline in MADRS total score.

Key Points: 
  • The graph presents results from the mixed model for repeated measures (MMRM) analysis of change from baseline in MADRS total score.
  • Due to the limited sample size, the study did not meet the pre-defined primary endpoint (MADRS ANCOVA at 24 hours post dosing).
  • "We believe these results demonstrate the therapeutic potential of SLS-002 to address this huge unmet need and those at risk.
  • SLS-002 was well-tolerated with no new or unique safety signals identified and there were no deaths reported in the study.

Firefly Neuroscience Inc. Unveils Groundbreaking Insights on BNA™ as an Effective Disease Management Program in Psychiatric Practice

Retrieved on: 
Friday, September 15, 2023

The practical application of BNA™ in a real-world clinical scenario has demonstrated promising results in enhancing treatment outcomes for patients in psychiatric care.

Key Points: 
  • The practical application of BNA™ in a real-world clinical scenario has demonstrated promising results in enhancing treatment outcomes for patients in psychiatric care.
  • TORONTO, Sept. 15, 2023 /PRNewswire/ - Firefly Neuroscience Inc. is thrilled to announce the groundbreaking findings of the recent comprehensive study, which explored the potential benefits of utilizing the Brain Network Analytics (BNA™) technology as a disease management program in psychiatric practice.
  • The study amassed data from 2,253 patients who sought treatment at a prominent psychiatric and multispecialty clinic in the US.
  • Jon Olsen, Chief Executive Officer at Firefly Neuroscience Inc., commented, "These findings underscore the transformative potential of BNA™ technology in revolutionizing psychiatric treatment.

California Legislature Passes AB 1437 to Reduce Access Barriers for Mental Health Patients

Retrieved on: 
Thursday, September 14, 2023

SACRAMENTO, Calif., Sept. 14, 2023 /PRNewswire/ -- Patients with serious mental illness in California will have better, more consistent access to prescribed medication thanks to AB 1437, a bill passed by the California State Legislature.

Key Points: 
  • Reform marks a victory for patients with serious mental illness and encourages stability, timely treatment
    SACRAMENTO, Calif., Sept. 14, 2023 /PRNewswire/ -- Patients with serious mental illness in California will have better, more consistent access to prescribed medication thanks to AB 1437, a bill passed by the California State Legislature.
  • The Alliance for Patient Access, the California Access Coalition and the Psychiatric Physicians Alliance of California thank Assembly Members Jacqui Irwin and Sharon Quirk-Silva and applaud the California State Legislature for passing AB 1437 with wide bipartisan support.
  • "AB 1437 is a straightforward, transformational step in ensuring patients remain stable and retain access to their already approved medications," said Rimal Bera, MD, chairman of the Alliance for Patient Access' Mental Health Working Group.
  • I'm encouraged that the legislature has recognized this and taken steps to ensure appropriate mental health care for Californians.

Autobahn Therapeutics Completes Dosing in its Phase 1 Multiple-ascending Dose Study of ABX-002 for Major Depressive Disorder and Reports Company Progress

Retrieved on: 
Monday, September 11, 2023

Dr. Davar is an accomplished neurologist and neuroscientist with three decades of corporate and academic leadership in neuroscience research.

Key Points: 
  • Dr. Davar is an accomplished neurologist and neuroscientist with three decades of corporate and academic leadership in neuroscience research.
  • The company plans to assess and report topline data from the Phase 1 study in the fourth quarter of 2023.
  • Based on the Phase 1 experience, Autobahn plans to submit an investigational new drug (IND) application to the US.
  • The company plans to progress ABX-101 through IND-enabling studies in 2024 to support advancement into Phase 1 clinical development.