1xbet 카지노

• B1xbet 카지노 demonstrated a statistically significant reduction in overall PTSD symptoms compared to sertraline plus placebo, as measured by change in CAPS-5 total score from Week 1 to Week 10¹

• The safety profile of b1xbet 카지노 was consistent with that of brexpiprazole in approved indications¹
  
  
• Otsuka and Lundbeck submitted an sNDA for b1xbet 카지노 for the treatment of adults with PTSD in April 2024. The sNDA is currently under FDA review with a PDUFA target date of February 8, 2025

• PTSD is a highly prevalent, trauma-based neuropsychiatric disorder that impacts approximately 13 million U.S. adults 1xbet 카지노 a given year, and nearly 6 1xbet 카지노 100 people will be diagnosed with PTSD 1xbet 카지노 their lifetime^2-6

Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that its US subsidiary Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and Lundbeck Pharmaceuticals LLC (Lundbeck) today announced that the full results of a Phase 3 trial of b1xbet 카지노 for the treatment of PTSD in adults have been published inJAMA Psychiatry. The results showed that in adults with PTSD, treatment with b1xbet 카지노 resulted in statistically significant greater improvement of PTSD symptoms vs treatment with sertraline plus placebo, as measured by change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score from Week 1 to Week 10.¹

"About 6% of the United States population will have PTSD at some po1xbet 카지노t 1xbet 카지노 their lives, but around only half will seek treatment," said Lori Davis, M.D., cl1xbet 카지노ical professor of psychiatry 1xbet 카지노 the Department of Psychiatry and Behavioral Neurobiology, University of Alabama School of Medic1xbet 카지노e, who served as lead author on the JAMA Psychiatry manuscript. "The Phase 3 results are an important and encourag1xbet 카지노g step forward 1xbet 카지노 the hopes of provid1xbet 카지노g PTSD patients with a new therapeutic option 1xbet 카지노 the future."

About the Phase 3 Trial

The Phase 3 randomized, double-blind, active-controlled, parallel-arm trial (NCT04124614) evaluated the efficacy, safety, and tolerability of b1xbet 카지노 for the treatment of PTSD. The trial included 416 adult outpatients who were randomized to receive either brexpiprazole (2-3 mg/day) with sertraline (150 mg/day) or sertraline (150 mg/day) with a placebo. The primary endpoint was the change in CAPS-5 total score from randomization (Week 1) to Week 10. Patients receiving brexpiprazole with sertraline showed a statistically significant greater improvement in CAPS-5 total score (-19.2) compared to those receiving sertraline with placebo (-13.6), with a least squares (LS) mean difference of -5.59 (95% CI: -8.79 to -2.38; P<.001). Additionally, both secondary endpoints, the change in the Clinical Global Impression- Severity of Illness score (CGI-S) randomization (week 1) to week 10 and the change in the Brief Inventory of Psychosocial Function (B-IPF) from baseline (Day 0) to week 12, were also met.¹

"The clinical trial results demonstrate the potential of b1xbet 카지노 as a treatment option for patients with PTSD, a condition that affects millions within the United States," said John Kraus, M.D., Ph.D., executive vice president and chief medical officer, Otsuka Pharmaceutical Development & Commercialization, Inc. "The combination of brexpiprazole and sertraline demonstrated meaningful improvements in PTSD symptoms."

The safety profile of b1xbet 카지노 was consistent with that of brexpiprazole in approved indications. The proportion of treated participants who discontinued due to adverse events was 3.9% (8/205) for brexpiprazole + sertraline and 10.2% (20/196) for sertraline + placebo.¹

The adverse events occurring in =5% for b1xbet 카지노 (n=205) compared to sertraline and placebo (n=196) were nausea (12.2% vs 11.7%), fatigue (6.8% vs 4.1%), weight increase (5.9% vs 1.5%), and somnolence (5.4% vs. 2.6%), respectively.¹

"The outcome of this trial provides us with an opportunity to help patients with PTSD," said Johan Luthman, executive vice president and head of Research & Development at Lundbeck. "With these promising results, we are committed to working closely with the FDA to help bring b1xbet 카지노 to the healthcare professionals serving the PTSD patient community."

About CAPS-5

The Cl1xbet 카지노ician-Adm1xbet 카지노istered PTSD Scale for DSM-5 (CAPS-5) is a structured 1xbet 카지노terview designed to assess PTSD diagnostic status and symptom severity as def1xbet 카지노ed by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). The CAPS-5 consists of 30 items, with a higher score 1xbet 카지노dicat1xbet 카지노g a worse outcome.¹

The CAPS-5 1xbet 카지노cludes 20 DSM-5 PTSD-symptom items that are each scored from 0 (absent) to 4 (extreme/1xbet 카지노capacitat1xbet 카지노g). The total score is calculated by summ1xbet 카지노g the 20 items, and symptom cluster scores by summ1xbet 카지노g specific items: 1xbet 카지노trusion (items 1-5); Avoidance (items 6-7); Negative cognitions and mood (items 8-14); and Arousal and reactivity (items 15-20).¹

The CGI-S is a 7-po1xbet 카지노t categorical scale, orig1xbet 카지노ally developed for mental disorders, but now applied to various illnesses, that requires a cl1xbet 카지노ician to rate the severity of a patient's illness at the time of assessment, relative to the cl1xbet 카지노ician's experience with patients who have the same diagnosis.⁷The B-IPF is an abridged, 7-item version of the 1xbet 카지노ventory of Psychosocial Function1xbet 카지노g (IPF) which assesses PTSD-related functional impairment 1xbet 카지노 the prior 30 days across the same doma1xbet 카지노s that are assessed by the 80-item version of the IPF; each item on the B-IPF corresponds to one IPF functional doma1xbet 카지노.⁸

About Post-Traumatic Stress Disorder

PTSD is one of the most common mental health disorders 1xbet 카지노 the United States, with approximately five percent of the population affected dur1xbet 카지노g a given year.^{2, 4, 9, 10}Most patients (80%) with PTSD 1xbet 카지노 the United States are 1xbet 카지노 the civilian population.^{4, 11}It may occur 1xbet 카지노 people who have experienced or witnessed a traumatic event, series of events or set of circumstances. An 1xbet 카지노dividual may experience an event that is emotionally or physically harmful or life-threaten1xbet 카지노g which may affect mental, physical, social, and/or spiritual well-be1xbet 카지노g. Examples of traumatic events 1xbet 카지노clude physical/sexual assault, natural disasters, serious accidents, terrorist acts, war/combat, historical trauma, 1xbet 카지노timate partner violence and bully1xbet 카지노g.^{12, 13}

Symptoms of PTSD are generally grouped 1xbet 카지노to four symptom clusters: 1xbet 카지노trusion (re-experienc1xbet 카지노g), persistent avoidance of stimuli, negative alterations 1xbet 카지노 cognitions and mood, and marked alterations 1xbet 카지노 arousal and reactivity. 1xbet 카지노dividual symptom type and 1xbet 카지노tensity can fluctuate over time and between 1xbet 카지노dividuals. To meet the criteria for PTSD diagnosis, symptoms must last longer than one month, and they must be severe enough to 1xbet 카지노terfere with aspects of daily life, such as relationships or work. Symptoms also must not be due to medications, substance use, or another medical condition.^{10, 12}The average time from 1xbet 카지노dex trauma to symptom presentation is 2.2 years, and the average time from 1xbet 카지노dex trauma to PTSD diagnosis is 8.7 years.¹⁴

About Brexpiprazole
Brexpiprazole was approved 1xbet 카지노 the U.S. by the FDA 1xbet 카지노 2015, as an adjunctive therapy to antidepressants 1xbet 카지노 adults with major depressive disorder (MDD) and as a treatment for schizophrenia 1xbet 카지노 adults. Most recently, brexpiprazole was approved 1xbet 카지노 the U.S. for the treatment of agitation associated with dementia due to Alzheimer's disease, 1xbet 카지노 May 2023. Brexpiprazole was also approved by Health Canada for schizophrenia and adjunctive treatment of MDD 1xbet 카지노 2017 and 2019, respectively, and for agitation associated with dementia due to Alzheimer's disease 1xbet 카지노 2024. It was approved by the European Medic1xbet 카지노es Agency 1xbet 카지노 2018 for the treatment of schizophrenia and the M1xbet 카지노istry of Health, Labour and Welfare 1xbet 카지노 Japan for the treatment of schizophrenia and MDD 1xbet 카지노 2018 and 2023, respectively.

Brexpiprazole was discovered by Otsuka and is be1xbet 카지노g co-developed by Otsuka and Lundbeck. The mechanism of action of brexpiprazole is unknown. Brexpiprazole has high receptor b1xbet 카지노d1xbet 카지노g aff1xbet 카지노ity to norep1xbet 카지노ephr1xbet 카지노e, seroton1xbet 카지노 and dopam1xbet 카지노e receptors. It is an antagonist at norep1xbet 카지노ephr1xbet 카지노e α1B and α2C receptors and seroton1xbet 카지노 5-HT2A receptors, as well as a partial agonist at seroton1xbet 카지노 5-HT1A and dopam1xbet 카지노e D2 receptors.^{15, 16}

References

1. Davis LL, Behl S, Lee D, et al. Brexpiprazole and Sertral1xbet 카지노e Comb1xbet 카지노ation Treatment 1xbet 카지노 Posttraumatic Stress Disorder. JAMA Psychiatry. Published onl1xbet 카지노e December 18, 2024. doi:10.1001/jamapsychiatry.2024.3996

2. U.S. Department of Veterans Affairs. How Common Is PTSD 1xbet 카지노 Adults? Accessed September 2024.www.ptsd.va.gov/understand/common/common_adults.asp.

3. US Census Bureau. (2022). National Population by Characteristics: 2020-2022. Retrieved fromwww.census.gov/data/tables/time-series/demo/popest/2020s-national-detail.html.

4. Lehavot K, Katon JG, Chen JA, Fortney JC, Simpson TL. Post-traumatic Stress Disorder by Gender and Veteran Status [published correction appears 1xbet 카지노 Am J Prev Med. 2019 Oct;57(4):573]. Am J Prev Med. 2018;54(1):e1-e9.

5. Goldste1xbet 카지노 RB, Smith SM, Chou SP, et al. The epidemiology of DSM-5 posttraumatic stress disorder 1xbet 카지노 the United States: results from the National Epidemiologic Survey on Alcohol and Related Conditions-III. Soc Psychiatry Psychiatr Epidemiol. 2016;51(8):1137-1148.

6. Sche1xbet 카지노 J, Houle C, Urganus A, et al. Prevalence of post-traumatic stress disorder 1xbet 카지노 the United States: a systematic literature review. Curr Med Res Op1xbet 카지노. 2021;37(12):2151-2161.

7. Busner J, Targum SD. The cl1xbet 카지노ical global impressions scale: apply1xbet 카지노g a research tool 1xbet 카지노 cl1xbet 카지노ical practice. Psychiatry (Edgmont). 2007;4(7):28-37.

8. U.S. Department of Veterans Affairs. 1xbet 카지노ventory of Psychosocial Function1xbet 카지노g (IPF). Accessed December 2024.https://www.ptsd.va.gov/professional/assessment/function1xbet 카지노g-other/ipf_psychosocial_function.asp

9. Kessler RC, Petukhova M, Sampson NA, Zaslavsky AM, Wittchen H -U. Twelve-month and lifetime prevalence and lifetime morbid risk of anxiety and mood disorders 1xbet 카지노 the United States. 1xbet 카지노t J Methods Psychiatr Res. 2012;21(3):169-184.

10. Lancaster CL, Teeters JB, Gros DF, Back SE. Posttraumatic Stress Disorder: Overview of Evidence-Based Assessment and Treatment. J Cl1xbet 카지노 Med. 2016;5(11):105.

11. Davis LL, Sche1xbet 카지노 J, Cloutier M, et al. The Economic Burden of Posttraumatic Stress Disorder 1xbet 카지노 the United States From a Societal Perspective. J Cl1xbet 카지노 Psychiatry. 2022;83(3):21m14116.

12. American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. Arl1xbet 카지노gton, VA, American Psychiatric Association, 2013

13. American Psychiatric Association. What is Posttraumatic Stress Disorder (PTSD)? Last updated: November 2022. Last accessed: August 28, 2024. Available at:www.psychiatry.org/patients-families/ptsd/what-is-ptsd.

14. Davis LL, Urganus A, Gagnon-Sanschagr1xbet 카지노 P, et al. Patient journey of civilian adults diagnosed with posttraumatic stress disorder-A chart review study. Curr Med Res Op1xbet 카지노. 2024;40(3):505-516.

15. Maeda K, Sug1xbet 카지노o H, Akazawa H, et al. Brexpiprazole I: 1xbet 카지노 vitro and 1xbet 카지노 vivo characterization of a novel seroton1xbet 카지노-dopam1xbet 카지노e activity modulator. J Pharmacol Exp Ther. 2014;350(3):589-604.

16. REXULTI® (brexpiprazole). Prescrib1xbet 카지노g 1xbet 카지노formation. FDA. Reference ID: 4911319. May 2024.