EUCTR2004-004409-24-DE进行中（未招募）不适用
A Multi-Centre, Randomised, Double-Blind, Parallel-Group, Placebo-Controlled,Flexible Dose Study to Evaluate the Efficacy, Safety and Tolerability of Extended-Release Bupropion Hydrochloride (150mg-300mg once daily) in Elderly Subjects with Major Depressive Disorder
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 364
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects must have the ability to comprehend the key components of the consent
- •form and must provide written informed consent prior to commencing any study specific assessments and procedures.
- •Male or female out-patients aged = 65 years at the time of consent.
- •Subjects with Major Depressive Disorder, single episode or recurrent, DSM-IV
- •(296.2/296.3) diagnosed with comprehensive psychiatric evaluation as assessed by
- •a physician with adequate training in psychiatry (e.g., Board Certification in US;
- •Certificate of Completion of Specialist Training in EU).
- •In the investigator’s opinion, subjects must have met DSM-IV criteria for their
- •current major depressive episode for at least 8 weeks.
- •Subject must have an IVRS HAMD-17 total score of = 18 at both the Screening Visit
- •and the Baseline Visit, as assessed via an Interactive Voice Response (IVR) rating
- •Subject has a CGI Severity of Illness (CGI-S) score of = 4 at the Screening Visit and Baseline Visit.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subject’s IVRS HAMD-17 total score increases or decreases by more than 25%
- •between the Screening and Baseline visits.
- •Subject has a history of manic episodes.
- •Subject has a past or current DSM-IV diagnosis of Schizophrenia, or any other
- •psychotic disorder(s).
- •Subject has a current DSM-IV Axis II diagnosis that would suggest nonresponsiveness to pharmacotherapy or non-compliance with the protocol (e.g.
- •antisocial or borderline personality disorders).
- •Subject has a diagnosis of anorexia nervosa or bulimia within the past 12 months.
- •Subject is diagnosed with dementia.
- •Subject has a score of = 24 on the Mini Mental State Exam (MMSE) at the Screening
- •Subject, in the investigator’s judgement, poses a homicidal or serious suicidal risk,
- •has made a suicide attempt within the six months prior to the Screening Visit or has
- •ever been homicidal.
- •Subject has current or past history of seizure disorder or brain injury (traumatic or disease-related), or any condition which, in the opinion of the investigator,
- •predisposes to seizure; subject treated with other medications or treatment regimens that lower seizure threshold; subject undergoing abrupt discontinuation of alcohol or sedatives (including benzodiazepines or benzodiazepine-like agents). Note: single childhood febrile seizure is not exclusionary.
- •Subject has had a myocardial infarction within 1 year prior to Screening Visit or as a
- •history of uncontrolled hypertension, or unstable heart disease within the 6 months
- •prior to the Screening Visit.
- •Subject has a history of medically significant adverse effect (including allergic
- •reaction) from bupropion hydrochloride, it’s excipients, or closely related
- •Subject is taking any medication with potential for pharmacokinetic interaction with
- •bupropion hydrochloride or closely related compounds. These medications should not be taken during the Screening, Treatment, or Follow-up phases of the study.
- •Subject has taken any psychotropic drugs within two weeks prior to the Baseline
- •Subject has taken bupropion hydrochloride in the last 6 months.
- •Subject has initiated psychotherapy within 3 months prior to the Screening Visit, or
- •plans to initiate psychotherapy during the study.
- •Subject has received electro-convulsive therapy (ECT) or trans-cranial magnetic
- •stimulation (TMS) within 6 months prior to the Screening Visit.
- •Subject has previously failed adequate courses (e.g. maximum-labelled doses for
- •= 4 weeks) of pharmacotherapy with two different classes of antidepressants.
- •Subject has a positive urine test at screening for illicit drug use and/or a history of
- •alcohol or substance abuse or dependence within the past 12 months or subject has a blood alcohol level of >15 mg/dl (0.015%) at the Screening Visit.
- •Subject has ECG or clinical evidence of atrial or ventricular hypertrophy;
- •intraventricular conduction defects (excluding incomplete right bundle branch block
- •in the absence of clinical evidence of heart disease); symptomatic coronary artery
- •disease (or any symptomatic cardiac disease); myocardial strain, ischaemia, or
- •infarct; atrial arrhythmia (must be in normal sinus rhythm); second- or third-degree
- •AV block; congestive heart failure; cor pulmonale; or any cardiac condition that the
- •investigator feels may predispose the subject to ischaemia or arrhythmia.
- •Subject has systolic blood pressure = 150 mmHg or diastolic blood pressure
- •= 95 mmHg at either the Screening Visit or Baseline Visit.
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