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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
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/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
Other publications