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.
- Conditions
- Major Depressive Disorder (MDD)
- Registration Number
- EUCTR2004-003803-19-SE
- Lead Sponsor
- GlaxoSmithKline Research & Development
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 546
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
system.
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
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
compounds.
Subject has taken any psychotropic drugs within 2 weeks prior to the Baseline Visit
including:
• 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method