ong-Term Administration Study of Aripiprazole as an Adjunctive Therapy in Patients with Major Depressive Disorder

Otsuka Pharmaceutical Co., Ltd.0 个研究点目标入组 100 人开始时间: 2009年3月23日最近更新: 2023年10月17日

适应症

试验速览

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•1) Patients who are either inpatients or outpatients
•2) Patients who have the ability to understand and to provide informed consent to the examination, observation, and evaluation processes specified in this protocol, and have signed the informed consent form based on a full understanding of the trial
•3) Patients diagnosed as having either 296.2x Major Depressive Disorder, Single Episode or 296.3x Major Depressive Disorder, Recurrent according to DSM-IV-TR, and for whom the current episode of major depressive disorder has been ongoing for more than 8 weeks.

•1) Female patients of child bearing potential who wish to become pregnant during the treatment period, or within 4 weeks after study completion/discontinuation
•2) Female patients who are pregnant, possibly pregnant, or breast feeding
•3) Patients judged to be unable to tolerate any type of antidpressant treatment (including drugs not being used in the current episode of major depressive disorder), based on treatment history to date
•4) Patients who have previously received electro-convulsive therapy
•5) Patients who have participated in clinical studies on medical devices or other drugs within the past month
•6) Patients at risk of having serious adverse events or developing symptoms that could interfere with safety and efficacy evaluations (such as symptoms of fibromyalgia syndrome overlapping with symptoms of depression), based on previous medical history
•7) Patients with a history or a complication of diabetes
•8) Patients with thyroid disease (excluding patients who are stabilized on drug therapy for at least 3 months)
•9) Patients with a history of serotonin syndrome or psychotropic neuroleptic malignant syndrome
•10) Patients with a history of seizure disorder (epilepsy etc.)

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