Interventional, randomised, double-blind, parallel-group,placebo-controlled, flexible-dose long-term study toevaluate the maintenance of efficacy and safety of 1 to 3mg/day of brexpiprazole as adjunctive treatment inpatients with major depressive disorder with aninadequate response to antidepressant treatment - N/A

H. Lundbeck A/S0 个研究点目标入组 2,924 人开始时间: 2013年4月18日最近更新: 2016年7月4日

适应症

试验速览

暂无简介。

•The patient is an outpatient consulting a psychiatrist.
•The patient has an MDD diagnosed according to DSM-IV-TR™. The current Major Depressive Episode (MDE) should be confirmed using the Mini International Neuropsychiatric Interview (MINI).
•The patient has a moderate to severe depression and an insufficient response to at least one and no more than three adequate antidepressant treatments.
•The patient agrees to protocol-defined use of effective contraception.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 2632
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 292

•1.The patient has any current psychiatric disorder or Axis I disorder (DSM-IV-TR™ criteria), established as the primary diagnosis, other than MDD.
•2.The patient has a current Axis II (DSM-IV-TR™) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypical or histrionic personality disorder.
•3.The patient has experienced/experiences hallucinations, delusions or any psychotic symptomatology in the current MDE.
•4.The patient suffers from mental retardation, organic mental disorders, or mental disorders due to a general medical condition (DSM-IV-TR™ criteria).
•5.The patient, in the opinion of the investigator or according to Columbia- Suicide Severity Rating Scale (C-SSRS), is at significant risk of suicide.
•6.The patient has had neuroleptic malignant syndrome.
•7.The patient has any relevant medical history or current presence of systemic disease.
•8.The patient has, at the Screening Visit an abnormal ECG that is, in the investigator's opinion, clinically significant.
•9.The patient has a history of cancer, other than basal cell or Stage 1 squamous cell carcinoma of the skin, that has not been in remission for >5 years prior to the first dose of IMP.
•10.The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.

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