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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Depressive Disorder

Intervention: GSK372475 (Drug); venlafaxine (Drug); placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

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

Secondary outcome: 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

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

Eligibility

Minimum age: 18 Years. Maximum age: 64 Years. Gender(s): Both.

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

Locations and Contacts

GSK Investigational Site, Li├Ęge 4000, Belgium

GSK Investigational Site, Mont-Godinne 5530, Belgium

GSK Investigational Site, Burgas 8000, Bulgaria

GSK Investigational Site, Varna 9010, Bulgaria

GSK Investigational Site, Tallinn 10614, Estonia

GSK Investigational Site, Tartu 50417, Estonia

GSK Investigational Site, Voru 65620, Estonia

GSK Investigational Site, Kuopio 70110, Finland

GSK Investigational Site, Turku 20100, Finland

GSK Investigational Site, Arcachon 33120, France

GSK Investigational Site, Paris 75012, France

GSK Investigational Site, Toulouse 31000, France

GSK Investigational Site, Bangalore 560010, India

GSK Investigational Site, Chennai 600003, India

GSK Investigational Site, Hyderabad 500 034, India

GSK Investigational Site, Tirupati 517507, India

GSK Investigational Site, Bialystok 15-879, Poland

GSK Investigational Site, Gdansk 80-282, Poland

GSK Investigational Site, Lublin 20-442, Poland

GSK Investigational Site, Skorzewo 60-185, Poland

GSK Investigational Site, Bratislava 826 06, Slovakia

GSK Investigational Site, Michalovce 071 01, Slovakia

GSK Investigational Site, Observatory ,Cape Town 7925, South Africa

GSK Investigational Site, Somerset West 7140, South Africa

GSK Investigational Site, Somerset West 7500, South Africa

GSK Investigational Site, Vereeniging 1929, South Africa

GSK Investigational Site, Edmonton, Alberta T6L 5X8, Canada

GSK Investigational Site, Muenchen, Bayern 80333, Germany

GSK Investigational Site, Unterhaching, Bayern 82008, Germany

GSK Investigational Site, Wuerzburg, Bayern 97070, Germany

GSK Investigational Site, Kelowna, British Columbia V1Y 2H4, Canada

GSK Investigational Site, Schwerin, Mecklenburg-Vorpommern 19053, Germany

GSK Investigational Site, Westerstede, Niedersachsen 26655, Germany

GSK Investigational Site, Sydney, Nova Scotia B1S 2E8, Canada

GSK Investigational Site, Sydney, Nova Scotia B1P 1C6, Canada

GSK Investigational Site, Burlington, Ontario L7R 4E2, Canada

GSK Investigational Site, Mississauga, Ontario L5M 4N4, Canada

GSK Investigational Site, Montreal, Quebec H2T 2N6, Canada

GSK Investigational Site, Auchenflower, Queensland 4066, Australia

GSK Investigational Site, Kippa Ring, Queensland 4021, Australia

GSK Investigational Site, Epping, Victoria 3076, Australia

GSK Investigational Site, Heidelberg West, Victoria 3081, Australia

Additional Information

Related publications:

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.

Starting date: April 2007
Last updated: October 2, 2014

Page last updated: August 23, 2015

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