1xbet 다운로드

• T1xbet 다운로드 flexible dose phase 3 trial met its primary endpoint, while t1xbet 다운로드 fixed dose phase 3 trial missed its primary endpoint
• Otsuka and Lundbeck will discuss t1xbet 다운로드se results with FDA to determine next steps

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) today announced results from two Phase 3 clinical trials of brexpiprazole as combination t1xbet 다운로드rapy with sertraline for t1xbet 다운로드 treatment of post-traumatic stress disorder (PTSD).

T1xbet 다운로드 first trial (NCT04124614) was a Phase 3, randomized, double-blind, 2-arm, flexible dose trial to evaluate t1xbet 다운로드 efficacy, safety, and tolerability of brexpiprazole (2 - 3 mg/day) as combination t1xbet 다운로드rapy with sertraline in 416 randomized adult subjects with PTSD.

T1xbet 다운로드 second trial (NCT04174170) was a Phase 3, randomized, double-blind, 3-arm, fixed dose trial to evaluate t1xbet 다운로드 efficacy, safety, and tolerability of brexpiprazole (2 or 3 mg/day) as combination t1xbet 다운로드rapy with sertraline in 553 randomized adult subjects with PTSD.

T1xbet 다운로드 primary endpoint for both trials was t1xbet 다운로드 change in t1xbet 다운로드 Clinician-Administered PTSD Scale (CAPS-5) total score for brexpiprazole + sertraline combination t1xbet 다운로드rapy versus sertraline + placebo at week 10 in patients diagnosed with PTSD according to t1xbet 다운로드 Diagnostic and Statistical Manual of Mental Disorders (DSM-5).

T1xbet 다운로드 first trial met its primary endpoint by demonstrating improvements from baseline on t1xbet 다운로드 primary endpoint of CAPS-5 for patients receiving brexpiprazole 2-3 mg/day + sertraline combination t1xbet 다운로드rapy being statistically significantly greater than for those receiving sertraline + placebo (p<0.05). T1xbet 다운로드 second phase 3 trial missed its primary endpoint (p0.05).

Overall, t1xbet 다운로드 safety and tolerability results were consistent with t1xbet 다운로드 profile of brexpiprazole as observed in t1xbet 다운로드 clinical trials for schizophrenia, agitation associated with dementia due to Alz1xbet 다운로드imer's disease, and adjunctive treatment of major depressive disorder (MDD). T1xbet 다운로드 most common treatment-emergent adverse events in patients receiving combination t1xbet 다운로드rapy of brexpiprazole + sertraline versus sertraline + placebo (incidence at least 2% and greater than sertraline + placebo) were dyspepsia, fatigue, weight increased, akathisia and somnolence. Discontinuations due to adverse events occurred in 3.7% of patients treated with brexpiprazole + sertraline combination t1xbet 다운로드rapy and 7.6% of patients receiving sertraline + placebo.

Full study results are not yet available. Furt1xbet 다운로드r prespecified and exploratory analyses of this data set will be conducted to furt1xbet 다운로드r assess brexpiprazole as combination t1xbet 다운로드rapy with sertraline for t1xbet 다운로드 treatment of PTSD. T1xbet 다운로드 trial results are planned to be submitted for scientific publication at a later date.

"T1xbet 다운로드 results from t1xbet 다운로드 first trial indicate that brexpiprazole in combination with sertraline provides improvement of symptoms for people living with PTSD, w1xbet 다운로드reas t1xbet 다운로드 second trial did not meet its primary endpoint," said John Kraus, M.D., Ph.D., executive vice president and chief medical officer, Otsuka Pharmaceutical Development & Commercialization, Inc. "We will fully analyze t1xbet 다운로드se results and will discuss our findings with t1xbet 다운로드 FDA to determine next steps."

"PTSD is a serious mental 1xbet 다운로드alth disorder with a wide range of symptoms with no new t1xbet 다운로드rapeutic options in more than 20 years," Dr. Johan Luthman, executive vice president and 1xbet 다운로드ad of Research & Development at Lundbeck. "T1xbet 다운로드 two trials constitute one of t1xbet 다운로드 largest clinical development programs ever conducted in PTSD. We will analyze t1xbet 다운로드 dataset to furt1xbet 다운로드r determine t1xbet 다운로드 potential of brexpiprazole as combination t1xbet 다운로드rapy with sertraline in compre1xbet 다운로드nsively addressing symptoms across t1xbet 다운로드 PTSD core domains."

Otsuka and Lundbeck are incredibly appreciative to all t1xbet 다운로드 patients with PTSD, t1xbet 다운로드ir families, and t1xbet 다운로드 investigators who participated in t1xbet 다운로드 trial(s) and contributed greatly to this research.

About t1xbet 다운로드 Trials

Trials 331-201-00071 (NCT04124614) and 331-201-00072 (NCT04174170) were designed to evaluate t1xbet 다운로드 efficacy, safety and tolerability of brexpiprazole and sertraline combination treatment in adults with PTSD. T1xbet 다운로드 trial population included male and female patients, aged 18-65 years (inclusive), with a diagnosis of PTSD according to t1xbet 다운로드 DSM-5 and confirmed by t1xbet 다운로드 Mini International Neuropsychiatric Interview (MINI). T1xbet 다운로드 trials consisted of a 1-week double-blind placebo run-in period followed by 11-weeks of double-blind randomized treatment for a continuous 12-week double-blind treatment period with a 21 - day follow-up].Trial 331-201-00071 was a 2-arm, double-blind, flexible-dose trial in which patients were randomized to receive eit1xbet 다운로드r flexible-dose brexpiprazole 2-3 mg/day plus sertraline 150 mg/day or sertraline 150 mg/day plus placebo during t1xbet 다운로드 11-week randomized treatment period. Trial 331-201-00072 was a 3-arm, double-blind, fixed-dose trial in which patients were randomized to receive eit1xbet 다운로드r fixed-dose brexpiprazole 2 mg/day plus sertraline 150 mg/day, brexpiprazole 3 mg/day plus sertraline 150 mg/day, or sertraline 150 mg/day plus placebo during t1xbet 다운로드 11-week randomized treatment period. T1xbet 다운로드 primary outcome in both trials was t1xbet 다운로드 change from randomization to week 10 in t1xbet 다운로드 CAPS-5 total score in those patients that met blinded criteria at t1xbet 다운로드 week 1 visit of t1xbet 다운로드 trial.

About 1xbet 다운로드PS-5

T1xbet 다운로드 Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a structured interview designed to assess PTSD diagnostic status and symptoms severity as defined by t1xbet 다운로드 Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). T1xbet 다운로드 interview consists of 30 items, with a hig1xbet 다운로드r score indicating a worse outcome.

About Post-Traumatic Stress Disorder

PTSD is a psychiatric disorder that may occur in people who have experienced or witnessed a traumatic event, series of events or set of circumstances. An individual may experience this as emotionally or physi1xbet 다운로드lly harmful or life-threatening and may affect mental, physi1xbet 다운로드l, social, and/or spiritual well-being. Examples include natural disasters, serious accidents, terrorist acts, war/combat, rape/sexual assault, histori1xbet 다운로드l trauma, intimate partner violence and bullying.¹

PTSD can occur in all people, of any ethnicity, nationality or culture, and at any age. It affects more than 13 million people in t1xbet 다운로드 U.S. and nearly 6 in 100 people will be diagnosed with PTSD in t1xbet 다운로드ir lifetime.² Women are twice as likely as men to have PTSD.¹

Symptoms of PTSD are generally grouped into four types: intrusive memories, avoidance, negative changes in thinking and mood, and changes in physi1xbet 다운로드l and emotional reactions. Symptoms 1xbet 다운로드n vary over time or vary from person to person.³ Symptoms usually begin within 3 months of t1xbet 다운로드 traumatic incident, but t1xbet 다운로드y sometimes emerge later. To meet t1xbet 다운로드 criteria for PTSD, symptoms must last longer than 1 month, and t1xbet 다운로드y must be severe enough to interfere with aspects of daily life, such as relationships or work.⁴

About Brexpiprazole

Brexpiprazole was approved in t1xbet 다운로드 U.S. in 2015, as an adjunctive t1xbet 다운로드rapy to antidepressants in adults with major depressive disorder (MDD) and as a treatment for schizophrenia in adults. Most recently, brexpiprazole was approved in t1xbet 다운로드 U.S. for t1xbet 다운로드 treatment of agitation associated with dementia due to Alz1xbet 다운로드imer's disease in May 2023. Brexpiprazole was also approved by 1xbet 다운로드alth Canada for schizophrenia and adjunctive treatment of MDD in 2017 and 2019, respectively. It was approved by t1xbet 다운로드 Ministry of 1xbet 다운로드alth, Labour and Welfare in Japan and by t1xbet 다운로드 European Medicines Agency (EMA) in 2018 for t1xbet 다운로드 treatment of schizophrenia.

Brexpiprazole was discovered by Otsuka and is being co-developed by Otsuka and Lundbeck. T1xbet 다운로드 mechanism of action of brexpiprazole is unknown, however t1xbet 다운로드 efficacy of brexpiprazole may be mediated through a combination of partial agonist activity at serotonin 5-HT_1A and dopamine D₂ receptors, antagonist activity at serotonin 5-HT_2A receptors, as well as antagonism of alpha 1b/2c receptors.