EUCTR2004-003803-19-SE进行中（未招募）不适用
A Multi-Centre, Randomised, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Flexible Dose Study Evaluating the Efficacy, Safety and Tolerability ofExtended-Release Bupropion Hydrochloride (150mg - 300mg once daily), Extended-Release Venlafaxine Hydrochloride (75mg - 150mg once daily) and Placebo in Subjects with Major Depressive Disorder.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 546
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
- •Subject must be an outpatient (male or female) and must be aged between 18 and 64 years (inclusive).
- •Subjects must have a diagnosis of 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).
- •* Physician assessment must include face-to-face evaluation of the subject, but may
- •be aided by subject evaluation conducted by a healthcare professional with a
- •clinically relevant qualification (e.g., psychiatric nurses or psychologists) and a
- •minimum of two years documented experience assessing patients with Major
- •Depressive Disorder.
- •In the investigator’s opinion, subject 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 must have a CGI Severity of Illness (CGI-S) score of =4 at both the
- •Screening Visit and the Baseline Visit.
- •Female subjects are eligible for entry into the study if she is of:
- •a. non child-bearing potential (i.e. physiologically incapable of becoming pregnant)
- •including any female who is pre-menarchal, post-menopausal or surgically sterile
- •(via hysterectomy, ovariectomy or bilateral ligation); or,
- •b. child-bearing potential, has a negative serum pregnancy test at the Screening Visit
- •and one of the following:
- •complete abstinence from intercourse from the Screening Visit throughout the
- •treatment phase of the study, and for a period of at least 7 days after completion of
- •the study or early withdrawal from the study, or,
- •has a male sexual partner who is surgically sterilized, or,
- •use of implants of levonorgesterel, or,
- •use of injectable progesterone, or,
- •use of oral contraceptive (combined or progesterone only), or,
- •use of double-barrier contraception, specifically, a spermicide plus a mechanical
- •barrier (e.g. male condom, female diaphragm), or,
- •use of any intrauterine device (IUD) with published data showing that the highest
- •expected failure rate is less than 1% per year, or,
- •use of any other method of contraception with data documented in the product
- •labelling as approved by regulatory agencies, or in the absence of approved labelling, in peer reviewed studies, showing that the highest expected failure rate for that method is less than 1% per year.
- •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
- •F.1.3 Elderly (>=65 years) no
- •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’s depressive symptoms are due to the direct physiological effects of a
- •general medical condition (e.g. hypothyroidism, Parkinson's disease, chronic pain).
- •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 last 12 months.
- •Subject, in the investigator's judgement, poses a homicidal or serious suicidal risk,
- •has made a suicide attempt within 6 months prior to the Screening Visit or has ever
- •been homicidal.
- •Subjects 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; those treated with other medications or treatment regimes that lower seizure threshold; those 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 the Screening Visit or
- •has a history of uncontrolled hypertension or unstable heart disease within the 6
- •months prior to the Screening Visit.
- •Subject has a history of a medically significant adverse effect (including allergic
- •reaction) from either bupropion hydrochloride, venlafaxine hydrochloride, their
- •excipients or closely related compounds.
- •Subject is taking any medication with potential for pharmacokinetic interaction with
- •either bupropion hydrochloride, venlafaxine hydrochloride or closely related
- •Subject has taken any psychotropic drugs within 2 weeks prior to the Baseline Visit
- •all antidepressants, including but not limited to monoamine oxidase inhibitors
- •(MAOIs), tricyclic antidepressants (TCAs), serotonin and noradrenaline reuptake
- •inhibitors (SNRIs), noradrenaline and dopamine reuptake inhibitors (NDRIs),
- •selective serotonin reuptake inhibitors (SSRIs) (with the exception of fluoxetine, for
- •which the time period is 4 weeks prior to the Baseline Visit)
- •benzodiazepines, sedatives or hypnotics (except for zolpidem, zopiclone or zaleplon, which may be used sparingly, at the recommended dosage, for night time sedation up to two weeks after randomisation)
- •other psychoactive medications (including psychoactive herbal treatments, e.g. St.
- •John's Wort).
- •Subject has received electroconvulsive therapy (ECT) or transcranial magnetic
- •stimulation (TMS) within the 6 months prior to the Screening Visit.
- •Subject has initiated psychotherapy within 3 months prior to the Screening Visit, or
- •plans to initiate psychotherapy during the study.
- •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); myocardial strain, ischaemia or
- •infarct; atrial arrythmia (must be in normal sinus rhythm); second- or third-degree
- •AV block; congestive heart failure; cor pulmonale; any cardiac condition that the
- •investigator feels may predispose the subject to ischaemia or arrythmia.
- •Subject has systolic
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