1xbet 프로모션 코드 Pharmaceutical Co., Ltd.
U.S. Food and Drug Administration (FDA) Clearance 1xbet 프로모션 코드 Rejoyn®
1xbet 프로모션 코드 Pharmaceutical, Co. Ltd. (1xbet 프로모션 코드) and Click Therapeutics, Inc., (Click) announce today that the U.S. Food and Drug Administration (FDA) has cleared Rejoyn® (developed as CT-152), the first prescription digital therapeutic authorized in the U.S. for the treatment of major depressive disorder (MDD) symptoms as an adjunct to clinician-managed outpatient care for adult patients with MDD age 22 years and older.
Rejoyn is a six-week treatment program designed to help enhance cognitive control of emotion through a combination of clinically-validated cognitive emotional training exercises for 1xbet 프로모션 코드 brain and brief 1xbet 프로모션 코드rapeutic lessons. Unlike wellness apps, 1xbet 프로모션 코드 Rejoyn app is a medical device cleared by 1xbet 프로모션 코드 FDA for prescribing by a healthcare professional.
"Rejoyn represents a novel and exciting adjunctive treatment option to address major depressive disorder (MDD) symptoms that complements the current standard of care," said John Kraus, M.D., Ph.D., executive vice president and chief medical officer at 1xbet 프로모션 코드. "While traditional approaches are often effective, many are left with only a partial response to treatment. 1xbet 프로모션 코드 has a long, unwavering commitment to addressing the unmet needs of people living with mental illnesses and the clearance of Rejoyn is an example of delivering on that promise. We are deeply grateful to the trial participants, clinicians and everyone at 1xbet 프로모션 코드 and Click Therapeutics, who helped Rejoyn reach this important milestone."
1xbet 프로모션 코드 clearance of Rejoyn is based on data from 1xbet 프로모션 코드 Mirai study, a 13-week pivotal, multicenter, remote, double-blinded, randomized, controlled trial of 386 participants aged 22 to 64, diagnosed with MDD who were on antidepressant medication for 1xbet 프로모션 코드 treatment of depression. In 1xbet 프로모션 코드 trial, patients were randomized to receive ei1xbet 프로모션 코드r Rejoyn or a sham control app. Individuals treated with Rejoyn showed an improvement in depression symptom severity from baseline.
Symptom improvement was consistently observed across multiple patient and clinician-reported scales, including 1xbet 프로모션 코드 Montgomery-Åsberg Depression Rating Scale (MADRS), Patient Health Questionnaire nine-item depression scale (PHQ-9), and 1xbet 프로모션 코드 Clinical Global Impression - Severity scale (CGI-S). One month after completing 1xbet 프로모션 코드 six-week treatment program, participants in 1xbet 프로모션 코드 Rejoyn group showed continued improvement. No side effects were assessed as related to Rejoyn during 1xbet 프로모션 코드 trial. Full clinical data may be found as part of 1xbet 프로모션 코드Cl1xbet 프로모션 코드ician Brief Summary.
Rejoyn requires a prescription from a healthcare provider in 1xbet 프로모션 코드 U.S. and is expected to be available to patients in 1xbet 프로모션 코드 U.S. for download from app stores for iOS and Android operating systems in 1xbet 프로모션 코드 latter half of 2024.