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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00644982




Registration number
NCT00644982
Ethics application status
Date submitted
24/03/2008
Date registered
27/03/2008
Date last updated
27/01/2021

Titles & IDs
Public title
A Comparison of Sertraline Versus Venlafaxine XR in the Treatment of Major Depression
Scientific title
A Multicenter Randomized, Double-Blind, Parallel-Group Study of Sertraline Versus Venlafaxine XR in the Acute Treatment of Outpatients With Major Depressive Disorder
Secondary ID [1] 0 0
A0501066
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 - sertraline
Treatment: Drugs - venlafaxine XR

Experimental: Sertaline group -

Active comparator: Venlafaxine group -


Treatment: Drugs: sertraline
Flexibly-titrated 50 mg tablets, 50-150 mg/day and venlafaxine placebo orally for 10 weeks.

Treatment: Drugs: venlafaxine XR
Flexibly-titrated 75 mg capsules, 75-225mg/day and sertraline placebo orally for 10 weeks.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in QOL, measured using the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q).
Timepoint [1] 0 0
Weeks 1, 2, 3, 4, 6, 8, 9 and 10.
Secondary outcome [1] 0 0
Change from baseline in the 17-item Hamilton-Depression Rating Scale (HAM-D) including response (=50% reduction in HAM-D total score from baseline) and remission (HAM-D total score =7) rates.
Timepoint [1] 0 0
Weeks 1, 2, 3, 4, 6, 8, 9 and 10.
Secondary outcome [2] 0 0
The 17-item Hamilton-Depression Rating Scale response rates at endpoint (week 8).
Timepoint [2] 0 0
Week 8
Secondary outcome [3] 0 0
CGI response rate at endpoint (week 8).
Timepoint [3] 0 0
Week 8
Secondary outcome [4] 0 0
Change from baseline in the CGI-Severity Scale (CGI-S).
Timepoint [4] 0 0
Weeks 1, 2, 3, 4, 6, 8, 9 and 10.
Secondary outcome [5] 0 0
Change from baseline in the Hamilton Anxiety Scale (HAM-A).
Timepoint [5] 0 0
Weeks 1, 2, 3, 4, 6, 8, 9 and 10.
Secondary outcome [6] 0 0
Change from baseline in the Endicott Work Productivity Scale (EWPS).
Timepoint [6] 0 0
Weeks 1, 8, 9, 10
Secondary outcome [7] 0 0
Change from baseline in the Visual Analogue Scale (VAS) for Depression.
Timepoint [7] 0 0
Weeks 1, 2, 3, 4, 6, 8, 9 and 10.
Secondary outcome [8] 0 0
Change from baseline in the Visual Analogue Scale (VAS) for Overall Assessment of Pain.
Timepoint [8] 0 0
Weeks 1, 2, 3, 4, 6, 8, 9 and 10.
Secondary outcome [9] 0 0
Hamilton-Depression Rating Scale remission rates at endpoint (week 8).
Timepoint [9] 0 0
Week 8
Secondary outcome [10] 0 0
Change from baseline in the Clinical Global Impression-Improvement Scale.
Timepoint [10] 0 0
Weeks 1, 2, 3, 4, 6, 8

Eligibility
Key inclusion criteria
* Primary diagnosis of DSM-IV Major Depressive Disorder, single episode or recurrent, without psychotic features. Additional DSM-IV Axis I diagnoses will be permitted only if they are identified as secondary diagnoses.
* Hamilton-Depression rating scale (HAM-D; 17 item) total score =18 and HAMD item 1 (depressed mood) score =2.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Use of an antidepressant within 2 weeks of baseline (4 weeks for fluoxetine)
* Current or past diagnosis of bipolar disorder or any psychotic disorder.

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?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
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
1/10/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2003
Sample size
Target
Accrual to date
Final
163
Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Cairns
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Everton Park
Recruitment hospital [3] 0 0
Pfizer Investigational Site - North Cairns
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Box Hill
Recruitment hospital [5] 0 0
Pfizer Investigational Site - Heidelberg
Recruitment hospital [6] 0 0
Pfizer Investigational Site - WEST Heidelberg
Recruitment hospital [7] 0 0
Pfizer Investigational Site - West Perth
Recruitment postcode(s) [1] 0 0
4870 - Cairns
Recruitment postcode(s) [2] 0 0
4053 - Everton Park
Recruitment postcode(s) [3] 0 0
4870 - North Cairns
Recruitment postcode(s) [4] 0 0
3128 - Box Hill
Recruitment postcode(s) [5] 0 0
3084 - Heidelberg
Recruitment postcode(s) [6] 0 0
3081 - WEST Heidelberg
Recruitment postcode(s) [7] 0 0
6005 - West Perth
Recruitment outside Australia
Country [1] 0 0
Turkey
State/province [1] 0 0
Adana
Country [2] 0 0
Turkey
State/province [2] 0 0
Ankara
Country [3] 0 0
Turkey
State/province [3] 0 0
Diyarbakir
Country [4] 0 0
Turkey
State/province [4] 0 0
Istanbul
Country [5] 0 0
Turkey
State/province [5] 0 0
Izmir
Country [6] 0 0
Turkey
State/province [6] 0 0
Izmit
Country [7] 0 0
Turkey
State/province [7] 0 0
Malatya

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00644982