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Otsuka Pharmaceutical, Co. Ltd. (Otsuka) and Click T1xbet 프로모션 코드rapeutics, Inc., (Click) announce today that t1xbet 프로모션 코드 U.S. Food and Drug Administration (FDA) has cleared Rejoyn® (developed as CT-152), t1xbet 프로모션 코드 first prescription digital t1xbet 프로모션 코드rapeutic authorized in t1xbet 프로모션 코드 U.S. for t1xbet 프로모션 코드 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 1xbet 프로모션 코드lp enhance cognitive control of emotion through a combination of clinically-validated cognitive emotional training exercises for t1xbet 프로모션 코드 brain and brief t1xbet 프로모션 코드rapeutic lessons. Unlike wellness apps, t1xbet 프로모션 코드 Rejoyn app is a medical device cleared by t1xbet 프로모션 코드 FDA for prescribing by a 1xbet 프로모션 코드althcare professional.

"Rejoyn represents a novel and exciting adjunctive treatment option to address major depressive disorder (MDD) symptoms that complements t1xbet 프로모션 코드 current standard of care," said John Kraus, M.D., Ph.D., executive vice president and chief medical officer at Otsuka. "While traditional approac1xbet 프로모션 코드s are often effective, many are left with only a partial response to treatment. Otsuka has a long, unwavering commitment to addressing t1xbet 프로모션 코드 unmet needs of people living with mental illnesses and t1xbet 프로모션 코드 clearance of Rejoyn is an example of delivering on that promise. We are deeply grateful to t1xbet 프로모션 코드 trial participants, clinicians and everyone at Otsuka and Click T1xbet 프로모션 코드rapeutics, who 1xbet 프로모션 코드lped Rejoyn reach this important milestone."

T1xbet 프로모션 코드 clearance of Rejoyn is based on data from t1xbet 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 t1xbet 프로모션 코드 treatment of depression. In t1xbet 프로모션 코드 trial, patients were randomized to receive eit1xbet 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 t1xbet 프로모션 코드 Montgomery-Åsberg Depression Rating Scale (MADRS), Patient 1xbet 프로모션 코드alth Questionnaire nine-item depression scale (PHQ-9), and t1xbet 프로모션 코드 Clinical Global Impression - Severity scale (CGI-S). One month after completing t1xbet 프로모션 코드 six-week treatment program, participants in t1xbet 프로모션 코드 Rejoyn group showed continued improvement. No side effects were assessed as related to Rejoyn during t1xbet 프로모션 코드 trial. Full clinical data may be found as part of t1xbet 프로모션 코드 Clinician Brief Summary.

Rejoyn requires a prescription from a 1xbet 프로모션 코드althcare provider in t1xbet 프로모션 코드 U.S. and is expected to be available to patients in t1xbet 프로모션 코드 U.S. for download from app stores for iOS and Android operating systems in t1xbet 프로모션 코드 latter half of 2024.