Last updated: 11/07/2018 15:25:35
Major Depressive Disorder In The Elderly
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: 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
Trial description: This is a placebo-controlled study evaluating the effectiveness of medication in elderly subjects with Major Depressive Disorder (MDD).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: bupropion XL
Enrollment:
364
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
K. Hewett, W. Chrzanowski, R. Jokinen, R. Felgentreff, RK Shrivastava, MD Gee, DS Wightman, MC O'Leary, LS Millen, MC Leon, MA Briggs, A. Krishen, and JG Modell . Double-blind, placebo-controlled evaluation of extended-release bupropion in elderly patients with major depressive disorder. J Psychopharmacol. 2010;24:521-529.
Medical condition
Depressive Disorder, Major
Product
bupropion
Collaborators
Not applicable
Study date(s)
June 2004 to October 2005
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
65+ years
Accepts healthy volunteers
No
- Primary diagnosis of Major Depressive Disorder with DSM-IV criteria for their current episode for at least 8 weeks.
- Patient has current or past history of seizure disorder or brain injury.
- Patient has a diagnosis of anorexia or bulimia within the past 12 months.
Inclusion and exclusion criteria
Inclusion criteria:
- Primary diagnosis of Major Depressive Disorder with DSM-IV criteria for their current episode for at least 8 weeks.
Exclusion criteria:
- Patient has current or past history of seizure disorder or brain injury.
- Patient has a diagnosis of anorexia or bulimia within the past 12 months.
- Patient has a past or current DMS-IV diagnosis of schizophrenia or any other psychotic disorder(s).
- Patient has had a myocardial infarction within 1 year or a history of uncontrolled hypertension or unstable heart disease with 6 months.
Trial location(s)
Location
GSK Investigational Site
Everton Park, Queensland, Australia, 4053
Status
Study Complete
Location
GSK Investigational Site
Caboolture, Queensland, Australia, 4510
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2005-20-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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