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

Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00448058
• Other study ID #: SND 103285
• Status: Completed
• Phase: Phase 2
• First received: March 13, 2007
• Last updated: October 2, 2014
• Start date: April 2007
• Est. completion date: December 2008

Study information

• Verified date: November 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the efficacy, safety, and tolerability of GSK372475 compared with placebo in the treatment of outpatient subjects with Major Depressive Disorder (MDD)

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 396
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Drug:
• GSK372475
daily administration during the 10-week treatment phase
• venlafaxine
daily administration during the 10-week treatment phase
• placebo
daily administration during the 10-week treatment phase

Locations

Country	Name	City	State
Australia	GSK Investigational Site	Auchenflower	Queensland
Australia	GSK Investigational Site	Epping	Victoria
Australia	GSK Investigational Site	Heidelberg West	Victoria
Australia	GSK Investigational Site	Kippa Ring	Queensland
Belgium	GSK Investigational Site	Liège
Belgium	GSK Investigational Site	Mont-Godinne
Bulgaria	GSK Investigational Site	Burgas
Bulgaria	GSK Investigational Site	Varna
Canada	GSK Investigational Site	Burlington	Ontario
Canada	GSK Investigational Site	Edmonton	Alberta
Canada	GSK Investigational Site	Kelowna	British Columbia
Canada	GSK Investigational Site	Mississauga	Ontario
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Sydney	Nova Scotia
Canada	GSK Investigational Site	Sydney	Nova Scotia
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tartu
Estonia	GSK Investigational Site	Voru
Finland	GSK Investigational Site	Kuopio
Finland	GSK Investigational Site	Turku
France	GSK Investigational Site	Arcachon
France	GSK Investigational Site	Paris
France	GSK Investigational Site	Toulouse
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Schwerin	Mecklenburg-Vorpommern
Germany	GSK Investigational Site	Unterhaching	Bayern
Germany	GSK Investigational Site	Westerstede	Niedersachsen
Germany	GSK Investigational Site	Wuerzburg	Bayern
India	GSK Investigational Site	Bangalore
India	GSK Investigational Site	Chennai
India	GSK Investigational Site	Hyderabad
India	GSK Investigational Site	Tirupati
Poland	GSK Investigational Site	Bialystok
Poland	GSK Investigational Site	Gdansk
Poland	GSK Investigational Site	Lublin
Poland	GSK Investigational Site	Skorzewo
Slovakia	GSK Investigational Site	Bratislava
Slovakia	GSK Investigational Site	Michalovce
South Africa	GSK Investigational Site	Observatory ,Cape Town
South Africa	GSK Investigational Site	Somerset West
South Africa	GSK Investigational Site	Somerset West
South Africa	GSK Investigational Site	Vereeniging

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Australia,  Belgium,  Bulgaria,  Canada,  Estonia,  Finland,  France,  Germany,  India,  Poland,  Slovakia,  South Africa, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from randomization to the end of the Treatment Phase (Week 10) on a depression rating scale.		Randomisation (week 0) And end of the treatment
Secondary	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		Randomisation (week 0) and at weeks 1,2,4,6,8 and week 10 (end of treatment phase)