Latest news with #Esketamine
Medscape
15-07-2025
- Health
- Medscape
Esketamine Monotherapy Safe, Effective for TRD: Phase 4 Data
TOPLINE: Esketamine monotherapy was associated with significantly alleviated symptoms of treatment-resistant depression (TRD) at day 28 compared to placebo in a new phase 4 trial. The research extends findings from an earlier trial that served as the basis for the January FDA approval of an expanded indication for esketamine alone in patients with TRD. METHODOLOGY: The phase 4, double-blind, placebo-controlled, randomized clinical trial was conducted from 2020 to 2024 at 51 outpatient centers in the US. Adults with major depressive disorder (mean age, 45.4 years; 61% women) with inadequate response to two or more oral antidepressants during the current depressive episode were included. After an antidepressant-free period of 2 or more weeks, participants were randomly assigned to receive intranasal esketamine monotherapy 56 mg (n = 86) or 84 mg (n = 95) or matching placebo (n = 197) twice weekly for 4 weeks. The primary outcome was a change in the Montgomery-Åsberg Depression Rating Scale (MADRS) score from baseline to day 28. Other outcomes included change in MADRS score at 24 hours post-first dose, rates of response and remission, and occurrence of adverse events. TAKEAWAY: Compared with placebo, esketamine at 56-mg and 84-mg doses was associated with a significant reduction in depressive symptoms at day 28 ( P < .001 for both), with corresponding effect sizes of 0.48 and 0.63, respectively. Both doses of esketamine were also linked to significantly alleviated depressive symptoms at 24 hours post-first dose compared to placebo (P = .004 and P = .006, respectively). Response and remission rates were significantly higher in both esketamine groups at all timepoints assessed than in the placebo group. The most common treatment-emergent adverse events for combined doses of esketamine were nausea (25%), dissociation (24%), dizziness (22%), and headache (19%). IN PRACTICE: 'This study supports esketamine monotherapy as an important option in the management of patients for whom [oral antidepressants] or other pharmacological treatments are no longer appropriate or acceptable,' the investigators wrote. 'Esketamine monotherapy can potentially address a significant unmet need for the especially vulnerable, untreated TRD subpopulation at risk of serious outcomes,' they added. SOURCE: The study was led by Adam Janik, MD, Department of Neuroscience, Johnson & Johnson, San Diego. It was published online on July 2 in JAMA Psychiatry. LIMITATIONS: The study's generalizability was limited by the exclusion of patients with significant psychiatric or medical comorbidities and substance dependence, as well as by limited racial and ethnic diversity among participants. DISCLOSURES: The study was funded by Janssen Research & Development. Several investigators reported being employees of, holding stocks in, or having financial ties with various organizations and pharmaceutical companies, including Johnson & Johnson and its Janssen division. Some investigators also reported holding patents for esketamine for the treatment of depression, with rights assigned to Johnson & Johnson. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
Time Business News
26-06-2025
- Health
- Time Business News
Charting a Path Through Common Mood Disorders: Medication and Evaluation Insights
Mental health challenges like depression, anxiety, ADHD, and bipolar disorder are more common than many realize. Understanding the importance of proper evaluation and treatment is key for individuals and parents seeking real solutions. As Gimel Health's precision psychiatry practice in New Jersey demonstrates, combining thorough diagnosis with personalized medication strategies leads to the most meaningful progress. An accurate Depression Evaluation goes far beyond ticking off a checklist. Effective assessments explore: Symptom severity and patterns over time Possible Resistant Depression Co‑existing conditions like anxiety or ADHD At Gimel Health, providers trained in molecular and cellular biology evaluate less‑obvious contributors to depression, such as inflammation or sleep disorders, as part of a holistic clinical review. Such depth avoids 'one‑size‑fits‑all' approaches and helps guide the choice of New Depression Medication or augmentative strategies. First‑line options like SSRIs or SNRIs can be highly effective. But for Resistant Depression, options expand to include augmentation (e.g., bupropion) or novel agents like esketamine. The key lies in careful monitoring and tailoring based on biological markers and patient response—exactly the kind of approach offered at Gimel Health. Recent FDA approvals, Esketamine (nasal spray) and Brexanolone, provide hope for those unresponsive to standard medications. These represent a shift toward faster onset and targeted mechanisms, reinforcing how precision medicine can redefine treatment for resistant cases. Treating Bipolar Depression Medication calls for mood stabilizers (e.g., lithium, lamotrigine) or atypical antipsychotics. Untreated, these phases can spiral into severe depression or mania. Personalized protocols—such as those at Gimel Health—balance efficacy with tolerability and track both mood and cognitive outcomes. Treatment for Mania centers on mood stabilizers and atypical antipsychotics. Providers should adjust dosing to prevent cycle shifts, like rapid cycling or mixed states. Regular evaluation of side effects and mental acuity is vital, ensuring stabilization without cognitive bluntness. ADHD Medications for Adults often include stimulant medications and non‑stimulants (e.g., atomoxetine), paired with behavioral support. Adult ADHD Treatment must be individualized and carefully managed—especially when other mood disorders are present. Gimel Health addresses ADHD within broader mental health contexts, benefiting from providers trained in dual diagnosis. ADHD and Bipolar disorder frequently co-occur—requiring nuanced diagnosis to differentiate attention issues from hypomania. Treatment protocols typically begin with mood stabilization before cautiously introducing ADHD medication. Resistant Depression Management: Some people don't respond to SSRIs or SNRIs. Integrating newer options and precise dosing based on biomarkers is essential. Complex Presentations: When ADHD and Bipolar overlap—or when anxiety and mood disorders coexist—misdiagnosis is common unless providers apply a structured, multidimensional evaluation. Avoiding Unintended Consequences: Introducing stimulants during mania can backfire. A phased, monitored approach is safest. Navigating mental health challenges like ADHD, bipolar disorder, and depression requires more than just symptom management, it demands insight, compassion, and a treatment plan tailored to each unique individual. Whether you're seeking clarity through a Depression Evaluation, exploring options for Medication for Anxiety and Depression, or looking into Adult ADHD Treatment, finding the right support is crucial. At facilities like Gimel Health, patients benefit from a precision-based approach that integrates cutting-edge science with deeply personalized care. From managing Resistant Depression to balancing co-occurring conditions like ADHD and Bipolar, their providers focus on uncovering the root causes and crafting treatment strategies that evolve with your needs. Mental health struggles can feel overwhelming, but they don't have to be a life sentence. With the right support system, accurate diagnosis, and thoughtful care. Whether that involves Bipolar Depression Medication, ADHD Medications for Adults, or Treatment for Mania, transformation is possible. The first step is understanding that progress isn't linear, and healing is deeply personal. What works for one person may not work for another—and that's exactly why precision psychiatry exists. By choosing a provider who sees you as more than your symptoms, you're choosing a future defined not by limitation, but by potential. So if you or someone you love is struggling, know this: real, sustainable change is possible—and it starts with the decision to pursue something better. TIME BUSINESS NEWS
Associated Press
19-05-2025
- Health
- Associated Press
Innovative Treatment Option for Depression Relief Now Available in Fox Chapel
New Directions offers SPRAVATO®, FDA-approved nasal spray for treatment-resistant depression, providing fast symptom relief and improved accessibility. PITTSBURGH, PA, UNITED STATES, May 19, 2025 / / -- New Directions Mental Health is thrilled to announce that its Fox Chapel clinic is now offering Spravato® as part of its commitment to providing innovative and effective treatment options for mental health. New Directions is proud to offer Spravato®, the first nasal spray approved by the FDA for treating adults with treatment resistant depression. Spravato®, also known as esketamine, is a fast-acting treatment, with clients often feeling relief from their depression symptoms within hours. It works by rapidly altering brain chemistry to provide relief from symptoms such as sadness, hopelessness, and loss of interest in activities. Historically Spravato® has been used in conjunction with an oral antidepressant; however, new FDA approval allows use of Spravato® without a concurrent oral antidepressant. Read more about this development here: Spravato® is administered at New Directions' approved clinics under the close supervision of a healthcare professional and is now more accessible than ever. In a short-term study, patients treated with Spravato® combined with an oral antidepressant experienced a faster and more significant reduction in depression symptoms after just 4 weeks, compared to those who received the placebo alongside an oral antidepressant ( ). This innovative treatment option has been shown to be effective for many individuals who have not responded well to traditional antidepressant medications or talk therapy alone. Spravato® is not a cure for depression, but it can provide significant relief from symptoms and help individuals regain their quality of life. To learn more about New Directions Mental Health and its array of mental health services including individual and group therapy, TMS therapy, medication management, and Spravato® treatment, visit To schedule a new client appointment or to discuss how mental health treatment can benefit you, a loved one, or your patients, call 724-237-8585 or visit About New Directions Mental Health and Transformations Care Network New Directions Mental Health is a proud member of Transformations Care Network (TCN). As a member of TCN, the New Directions team can accept more insurance plans and have access to cutting edge services and technological advancements. TCN provides the support, resources, and tools that your care team needs to transform lives in their communities. To learn more about Transformations Care Network, a family of outpatient mental health organizations, and the inspiring work they are doing to shape the future of mental health care, visit Erica McPeek Transformations Care Network email us here Visit us on social media: LinkedIn Instagram Facebook Legal Disclaimer: EIN Presswire provides this news content 'as is' without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.
7NEWS
28-04-2025
- Health
- 7NEWS
New ketamine-type nasal spray can help 30,000 Australians suffering depression
A new nasal spray, that's chemically similar to Ketamine, is being added to the Pharmaceutical Benefits Scheme, for adults with treatment resistant depression. Spravato® (Esketamine) is the first new type of depression medicine to be added to the PBS in 30 years. Professor Ian Hickie AO, Co-Director of Health and Policy, Brain and Mind Centre, University of Sydney says Spravato targets a different chemical in the brain, than traditional antidepressants. 'Treatment resistant depression is a very important and a very disabling illness in Australia. About one in seven Australians has a depressive illness, about two thirds of those will respond to commonly available psychological or medical treatments.' 'You will not be able to get this medicine from your GP and take it home and squirt it up your own nose.' Instead, it will be provided under strict medical supervision. Twice a week at first, weekly for the next month, and then weekly or fortnightly until depressive symptoms improve. The treatment will only be given to patients who have not responded adequately to at least two different antidepressants of adequate dose and duration. Pensioner or concession card holders will pay just $7.70 and general patients will pay $31.60 for each dose of the medicine. Veteran Garth Camac has been living with treatment resistant depression for 15 years, and untreated depression for 15 before that. 'It is an expensive medication and having it added to the PBS is a great thing.' During his service in the Australian Army, he was deployed to Iraq twice. In Malaysia, completing training, five of his men died in a horrific car accident. Life after war was a battle he couldn't seem to win. 'I've been in a really uncomfortable place where I've had to decide whether or not today is the day to kill myself, or can I go a little bit further.' 'I had no plans to be alive at 50.' He's now 52. For the past two years, he's been taking Spravato. 'It's taken me two years to get to where I am now.' 'I enjoy being out in public now, I'm not scanning for danger, I'm not worrying that something will explode.' If you or someone you know is struggling:
