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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
To assess the comparative efficacy of sertraline versus venlafaxine XR on measures of quality of life.
Trial website
https://clinicaltrials.gov/study/NCT00644982
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00644982