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A Study Of New Medicine (GSK 372475) For The Treatment Of Depression

Primary Purpose

Depressive Disorder

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GSK372475
venlafaxine
placebo
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder focused on measuring Flexible-dose, GSK372475, MDD, Venlafaxine XR, Major Depressive Disorder

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

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

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

GSK372475

Venlafaxine

placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change from randomization to the end of the Treatment Phase (Week 10) on a depression rating scale.

Secondary Outcome Measures

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

Full Information

First Posted
March 13, 2007
Last Updated
October 2, 2014
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00448058
Brief Title
A Study Of New Medicine (GSK 372475) For The Treatment Of Depression
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

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)
Detailed Description
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 Subjects Diagnosed with Major Depressive Disorder

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder
Keywords
Flexible-dose, GSK372475, MDD, Venlafaxine XR, Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
396 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GSK372475
Arm Type
Experimental
Arm Description
flexible-dose design from GSK372475 1.0 mg/day to GSK372475 2.0 mg/day
Arm Title
Venlafaxine
Arm Type
Active Comparator
Arm Description
Flexible- dose design from Venlafaxine XR 75 mg/day to Venlafaxine XR 225 mg/day
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
GSK372475
Intervention Description
daily administration during the 10-week treatment phase
Intervention Type
Drug
Intervention Name(s)
venlafaxine
Intervention Description
daily administration during the 10-week treatment phase
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
daily administration during the 10-week treatment phase
Primary Outcome Measure Information:
Title
Change from randomization to the end of the Treatment Phase (Week 10) on a depression rating scale.
Time Frame
Randomisation (week 0) And end of the treatment
Secondary Outcome Measure Information:
Title
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
Time Frame
Randomisation (week 0) and at weeks 1,2,4,6,8 and week 10 (end of treatment phase)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Auchenflower
State/Province
Queensland
ZIP/Postal Code
4066
Country
Australia
Facility Name
GSK Investigational Site
City
Kippa Ring
State/Province
Queensland
ZIP/Postal Code
4021
Country
Australia
Facility Name
GSK Investigational Site
City
Epping
State/Province
Victoria
ZIP/Postal Code
3076
Country
Australia
Facility Name
GSK Investigational Site
City
Heidelberg West
State/Province
Victoria
ZIP/Postal Code
3081
Country
Australia
Facility Name
GSK Investigational Site
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
GSK Investigational Site
City
Mont-Godinne
ZIP/Postal Code
5530
Country
Belgium
Facility Name
GSK Investigational Site
City
Burgas
ZIP/Postal Code
8000
Country
Bulgaria
Facility Name
GSK Investigational Site
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
GSK Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6L 5X8
Country
Canada
Facility Name
GSK Investigational Site
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 2H4
Country
Canada
Facility Name
GSK Investigational Site
City
Sydney
State/Province
Nova Scotia
ZIP/Postal Code
B1P 1C6
Country
Canada
Facility Name
GSK Investigational Site
City
Sydney
State/Province
Nova Scotia
ZIP/Postal Code
B1S 2E8
Country
Canada
Facility Name
GSK Investigational Site
City
Burlington
State/Province
Ontario
ZIP/Postal Code
L7R 4E2
Country
Canada
Facility Name
GSK Investigational Site
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5M 4N4
Country
Canada
Facility Name
GSK Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2T 2N6
Country
Canada
Facility Name
GSK Investigational Site
City
Tallinn
ZIP/Postal Code
10614
Country
Estonia
Facility Name
GSK Investigational Site
City
Tartu
ZIP/Postal Code
50417
Country
Estonia
Facility Name
GSK Investigational Site
City
Voru
ZIP/Postal Code
65620
Country
Estonia
Facility Name
GSK Investigational Site
City
Kuopio
ZIP/Postal Code
70110
Country
Finland
Facility Name
GSK Investigational Site
City
Turku
ZIP/Postal Code
20100
Country
Finland
Facility Name
GSK Investigational Site
City
Arcachon
ZIP/Postal Code
33120
Country
France
Facility Name
GSK Investigational Site
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
GSK Investigational Site
City
Toulouse
ZIP/Postal Code
31000
Country
France
Facility Name
GSK Investigational Site
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
80333
Country
Germany
Facility Name
GSK Investigational Site
City
Unterhaching
State/Province
Bayern
ZIP/Postal Code
82008
Country
Germany
Facility Name
GSK Investigational Site
City
Wuerzburg
State/Province
Bayern
ZIP/Postal Code
97070
Country
Germany
Facility Name
GSK Investigational Site
City
Schwerin
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
19053
Country
Germany
Facility Name
GSK Investigational Site
City
Westerstede
State/Province
Niedersachsen
ZIP/Postal Code
26655
Country
Germany
Facility Name
GSK Investigational Site
City
Bangalore
ZIP/Postal Code
560010
Country
India
Facility Name
GSK Investigational Site
City
Chennai
ZIP/Postal Code
600003
Country
India
Facility Name
GSK Investigational Site
City
Hyderabad
ZIP/Postal Code
500 034
Country
India
Facility Name
GSK Investigational Site
City
Tirupati
ZIP/Postal Code
517507
Country
India
Facility Name
GSK Investigational Site
City
Bialystok
ZIP/Postal Code
15-879
Country
Poland
Facility Name
GSK Investigational Site
City
Gdansk
ZIP/Postal Code
80-282
Country
Poland
Facility Name
GSK Investigational Site
City
Lublin
ZIP/Postal Code
20-442
Country
Poland
Facility Name
GSK Investigational Site
City
Skorzewo
ZIP/Postal Code
60-185
Country
Poland
Facility Name
GSK Investigational Site
City
Bratislava
ZIP/Postal Code
826 06
Country
Slovakia
Facility Name
GSK Investigational Site
City
Michalovce
ZIP/Postal Code
071 01
Country
Slovakia
Facility Name
GSK Investigational Site
City
Observatory ,Cape Town
ZIP/Postal Code
7925
Country
South Africa
Facility Name
GSK Investigational Site
City
Somerset West
ZIP/Postal Code
7140
Country
South Africa
Facility Name
GSK Investigational Site
City
Somerset West
ZIP/Postal Code
7500
Country
South Africa
Facility Name
GSK Investigational Site
City
Vereeniging
ZIP/Postal Code
1929
Country
South Africa

12. IPD Sharing Statement

Citations:
PubMed Identifier
22048884
Citation
Learned S, Graff O, Roychowdhury S, Moate R, Krishnan KR, Archer G, Modell JG, Alexander R, Zamuner S, Lavergne A, Evoniuk G, Ratti E. Efficacy, safety, and tolerability of a triple reuptake inhibitor GSK372475 in the treatment of patients with major depressive disorder: two randomized, placebo- and active-controlled clinical trials. J Psychopharmacol. 2012 May;26(5):653-62. doi: 10.1177/0269881111424931. Epub 2011 Nov 2.
Results Reference
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A Study Of New Medicine (GSK 372475) For The Treatment Of Depression

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