A randomized, double-blind, parallel-group study of the safety and efficacy of RO4917523 versus placebo, as adjunctive therapy in patients with major depressive disorder with inadequate response to ongoing antidepressant treatment.

F. Hoffmann-La Roche Ltd0 个研究点目标入组 300 人开始时间: 2011年9月27日最近更新: 2014年10月27日

试验速览

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•Primary diagnosis of Major Depressive Disorder (MDD) without psychotic features as defined by DSM-IV-TR criteria, and determined on the basis of the MINI structured interview.
•Having inadequate response to an ongoing antidepressant treatment:
•Inadequate response, defined as a CGI-S score of at least moderately ill and a priory determined level of severity in MADRS score.
•Antidepressant treatment defined as pharmacotherapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI) of at least 6 weeks duration at the minimum acceptable dose.
•Dose and duration of ongoing antidepressant treatment must be verified during the screening period
•Having at least one but no more than three antidepressant treatment failures within the current depressive episode.
•Age 18 -70
•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 150
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 150

•Currently receiving treatment with a combination of antidepressants (two or more), or on adjunctive or potentiating treatment.
•Previously received RO4917523
•Past or current use (defined a priory) of Electroconvulsive Therapy, Repetitive Transcranial Magnetic Stimulation, Vagus Nerve Stimulation, or Deep Brain Stimulation may be exclusionary
•Other current DSM-IV-TR axis I diagnosis. Comorbid anxiety which dominates the clinical presentation or troubles the patient the most is not accepted: Obszessive-Compulsive Disorder (OCD) and Posttraumatic Stress Disorder (PTSD) are specifically not allowed under an circumstances.
•Current or past history of psychotic symptoms or of Bipolar Disorder

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