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
Study complete
Study complete
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:
Enrollment:
364
Primary completion date:
Not applicable
Observational study model:
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)
Showing 1 - 6 of 16 Results
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
Study complete
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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