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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00093288




Registration number
NCT00093288
Ethics application status
Date submitted
5/10/2004
Date registered
7/10/2004
Date last updated
2/09/2013

Titles & IDs
Public title
Major Depressive Disorder In The Elderly
Scientific 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
Secondary ID [1] 0 0
AK130940
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depressive Disorder, Major 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - bupropion XL

Treatment: Drugs: bupropion XL
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Montgomery-Asberg Depression Rating Scale
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Montgomery-Asberg Depression Rating Scale Clinical Global Impression Improvement Scale Clinical Global Impression Severity Scale Hamilton Anxiety Rating Scale
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
- Primary diagnosis of Major Depressive Disorder with DSM-IV criteria for their current
episode for at least 8 weeks.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2005
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Caboolture
Recruitment hospital [2] 0 0
GSK Investigational Site - Everton Park
Recruitment hospital [3] 0 0
GSK Investigational Site - New Farm
Recruitment hospital [4] 0 0
GSK Investigational Site - St. Albans
Recruitment postcode(s) [1] 0 0
4510 - Caboolture
Recruitment postcode(s) [2] 0 0
4053 - Everton Park
Recruitment postcode(s) [3] 0 0
4005 - New Farm
Recruitment postcode(s) [4] 0 0
3021 - St. Albans
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Liège
Country [2] 0 0
Belgium
State/province [2] 0 0
Mont-Godinne
Country [3] 0 0
Belgium
State/province [3] 0 0
Montignies-sur-Sambre
Country [4] 0 0
Finland
State/province [4] 0 0
Mikkeli
Country [5] 0 0
Netherlands
State/province [5] 0 0
Amersfoort
Country [6] 0 0
Netherlands
State/province [6] 0 0
Grubbenvorst
Country [7] 0 0
Netherlands
State/province [7] 0 0
Hilversum
Country [8] 0 0
Netherlands
State/province [8] 0 0
Hoogvliet
Country [9] 0 0
Netherlands
State/province [9] 0 0
Wildervank
Country [10] 0 0
Norway
State/province [10] 0 0
Oslo
Country [11] 0 0
Russian Federation
State/province [11] 0 0
Moscow

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a placebo-controlled study evaluating the effectiveness of medication in elderly
subjects with Major Depressive Disorder (MDD).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00093288
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00093288