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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/NCT00448058




Registration number
NCT00448058
Ethics application status
Date submitted
13/03/2007
Date registered
15/03/2007
Date last updated
10/10/2014

Titles & IDs
Public title
A Study Of New Medicine (GSK 372475) For The Treatment Of Depression
Scientific title
A Ten-Week, Multicenter, Randomized, Double-Blind, Placebo and Active-Controlled, Parallel-Group, Flexible-Dose Study Evaluating the Efficacy, Safety, and Tolerability of GSK372475 (1.5 mg/Day to 2.0 mg/Day) or Extended Release Venlafaxine XR (150 mg/Day to 225 mg/Day) Compared to Placebo in Adult s
Secondary ID [1] 0 0
SND 103285
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depressive Disorder 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 - GSK372475
Treatment: Drugs - venlafaxine
Treatment: Drugs - placebo

Experimental: GSK372475 - flexible-dose design from GSK372475 1.0 mg/day to GSK372475 2.0 mg/day

Active Comparator: Venlafaxine - Flexible- dose design from Venlafaxine XR 75 mg/day to Venlafaxine XR 225 mg/day

Placebo Comparator: placebo -


Treatment: Drugs: GSK372475
daily administration during the 10-week treatment phase

Treatment: Drugs: venlafaxine
daily administration during the 10-week treatment phase

Treatment: Drugs: placebo
daily administration during the 10-week treatment phase
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from randomization to the end of the Treatment Phase (Week 10) on a depression rating scale.
Timepoint [1] 0 0
Randomisation (week 0) And end of the treatment
Secondary outcome [1] 0 0
Endpoints related to response & remission on depression rating scales during time of treatment exposureChange during treatment & at endpoint-week 10:in Clinical Global Impression scale; in motivation, energy, & sexual functioning on patient-rated scales
Timepoint [1] 0 0
Randomisation (week 0) and at weeks 1,2,4,6,8 and week 10 (end of treatment phase)

Eligibility
Key inclusion criteria
- Major depressive episode (MDE) associated with Major Depressive Disorder (DSM-IV-TR
criteria)

- Duration of current episode is at least 12 weeks duration and less than 2 years

- Symptoms of decreased energy, pleasure, and interest

- Female subjects who agree to use acceptable methods of birth control throughout the
study
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

- Current diagnosis of Panic Disorder, or symptoms of generalized anxiety or panic
attacks that could interfere with their ability to complete the trial

- Symptoms of MDE better accounted for by another diagnosis

- Diagnosis of Bipolar, schizophrenia, other psychotic disorder(s), borderline or
antisocial personality disorder, or dementia.

- Started psychotherapy within 3 months prior to the Screening

- Received electroconvulsive therapy or transcranial magnetic stimulation within 6
months prior to screening

- Received psychoactive drugs within 4 weeks of randomization

- Positive urine drug screen or positive blood alcohol

- Suicidal risk or has had any previous suicide attempt, a family history of suicide
attempt

- Positive pregnancy test

- History of seizure disorder, myocardial infarction (< 1yr), or unstable medical
condition

- Failed to respond to an adequate course of pharmacotherapy of at least 2 different
antidepressants

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 administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
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
1/04/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2008
Sample size
Target
Accrual to date
Final
396
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Auchenflower
Recruitment hospital [2] 0 0
GSK Investigational Site - Kippa Ring
Recruitment hospital [3] 0 0
GSK Investigational Site - Epping
Recruitment hospital [4] 0 0
GSK Investigational Site - Heidelberg West
Recruitment postcode(s) [1] 0 0
4066 - Auchenflower
Recruitment postcode(s) [2] 0 0
4021 - Kippa Ring
Recruitment postcode(s) [3] 0 0
3076 - Epping
Recruitment postcode(s) [4] 0 0
3081 - Heidelberg West
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
Bulgaria
State/province [3] 0 0
Burgas
Country [4] 0 0
Bulgaria
State/province [4] 0 0
Varna
Country [5] 0 0
Canada
State/province [5] 0 0
Alberta
Country [6] 0 0
Canada
State/province [6] 0 0
British Columbia
Country [7] 0 0
Canada
State/province [7] 0 0
Nova Scotia
Country [8] 0 0
Canada
State/province [8] 0 0
Ontario
Country [9] 0 0
Canada
State/province [9] 0 0
Quebec
Country [10] 0 0
Estonia
State/province [10] 0 0
Tallinn
Country [11] 0 0
Estonia
State/province [11] 0 0
Tartu
Country [12] 0 0
Estonia
State/province [12] 0 0
Voru
Country [13] 0 0
Finland
State/province [13] 0 0
Kuopio
Country [14] 0 0
Finland
State/province [14] 0 0
Turku
Country [15] 0 0
France
State/province [15] 0 0
Arcachon
Country [16] 0 0
France
State/province [16] 0 0
Paris
Country [17] 0 0
France
State/province [17] 0 0
Toulouse
Country [18] 0 0
Germany
State/province [18] 0 0
Bayern
Country [19] 0 0
Germany
State/province [19] 0 0
Mecklenburg-Vorpommern
Country [20] 0 0
Germany
State/province [20] 0 0
Niedersachsen
Country [21] 0 0
India
State/province [21] 0 0
Bangalore
Country [22] 0 0
India
State/province [22] 0 0
Chennai
Country [23] 0 0
India
State/province [23] 0 0
Hyderabad
Country [24] 0 0
India
State/province [24] 0 0
Tirupati
Country [25] 0 0
Poland
State/province [25] 0 0
Bialystok
Country [26] 0 0
Poland
State/province [26] 0 0
Gdansk
Country [27] 0 0
Poland
State/province [27] 0 0
Lublin
Country [28] 0 0
Poland
State/province [28] 0 0
Skorzewo
Country [29] 0 0
Slovakia
State/province [29] 0 0
Bratislava
Country [30] 0 0
Slovakia
State/province [30] 0 0
Michalovce
Country [31] 0 0
South Africa
State/province [31] 0 0
Observatory ,Cape Town
Country [32] 0 0
South Africa
State/province [32] 0 0
Somerset West
Country [33] 0 0
South Africa
State/province [33] 0 0
Vereeniging

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

Ethics approval
Ethics application status

Summary
Brief summary
To evaluate the efficacy, safety, and tolerability of GSK372475 compared with placebo in the
treatment of outpatient subjects with Major Depressive Disorder (MDD)
Trial website
https://clinicaltrials.gov/ct2/show/NCT00448058
Trial related presentations / publications
Learned S, Graff O, Roychowdhury S, Moate R, Krishnan KR, Archer G, Modell J, Alexander R, Zamuner S, Lavergne A, Evoniuk G, Ratti E. Results of Two Double-Blind, Placebo- and Active-Controlled Studies of GSK372475, a Triple Monoamine Reuptake Inhibitor, in the Treatment of Major Depressive Disorder. [J Psychopharmacol EPublication ahead of print. DOI 10.1177/0269881111424931]. 2011;
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/NCT00448058