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
- Conditions
- Major Depressive Disorder (MDD)
- Registration Number
- EUCTR2004-004409-24-DE
- Lead Sponsor
- GlaxoSmithKline Research & Development
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 364
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
system.
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
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
Visit.
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
compounds.
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
Visit.
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.
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