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

NCT00448058 | Completed Phase 2

• 1 other identifier: SND 103285
• Study Type: interventional
• Target: 396
• Locations: 12 countries
• Sites: 42

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)

Conditions

Depressive Disorder

Keywords

Flexible-dose; GSK372475; MDD; Venlafaxine XR; Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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)

Study Arms (3)

GSK372475

EXPERIMENTAL

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

Drug: GSK372475

Venlafaxine

ACTIVE COMPARATOR

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

Drug: venlafaxine

placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

GSK372475 DRUG

daily administration during the 10-week treatment phase

GSK372475

venlafaxine DRUG

daily administration during the 10-week treatment phase

Venlafaxine

placebo DRUG

daily administration during the 10-week treatment phase

placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (42)

GSK Investigational Site

Auchenflower, Queensland, 4066, Australia

Location

GSK Investigational Site

Kippa-Ring, Queensland, 4021, Australia

Location

GSK Investigational Site

Epping, Victoria, 3076, Australia

Location

GSK Investigational Site

Heidelberg West, Victoria, 3081, Australia

Location

GSK Investigational Site

Liège, 4000, Belgium

Location

GSK Investigational Site

Mont-Godinne, 5530, Belgium

Location

GSK Investigational Site

Burgas, 8000, Bulgaria

Location

GSK Investigational Site

Varna, 9010, Bulgaria

Location

GSK Investigational Site

Edmonton, Alberta, T6L 5X8, Canada

Location

GSK Investigational Site

Kelowna, British Columbia, V1Y 2H4, Canada

Location

GSK Investigational Site

Sydney, Nova Scotia, B1P 1C6, Canada

Location

GSK Investigational Site

Sydney, Nova Scotia, B1S 2E8, Canada

Location

GSK Investigational Site

Burlington, Ontario, L7R 4E2, Canada

Location

GSK Investigational Site

Mississauga, Ontario, L5M 4N4, Canada

Location

GSK Investigational Site

Montreal, Quebec, H2T 2N6, Canada

Location

GSK Investigational Site

Tallinn, 10614, Estonia

Location

GSK Investigational Site

Tartu, 50417, Estonia

Location

GSK Investigational Site

Võru, 65620, Estonia

Location

GSK Investigational Site

Kuopio, 70110, Finland

Location

GSK Investigational Site

Turku, 20100, Finland

Location

GSK Investigational Site

Arcachon, 33120, France

Location

GSK Investigational Site

Paris, 75012, France

Location

GSK Investigational Site

Toulouse, 31000, France

Location

GSK Investigational Site

Munich, Bavaria, 80333, Germany

Location

GSK Investigational Site

Unterhaching, Bavaria, 82008, Germany

Location

GSK Investigational Site

Würzburg, Bavaria, 97070, Germany

Location

GSK Investigational Site

Westerstede, Lower Saxony, 26655, Germany

Location

GSK Investigational Site

Schwerin, Mecklenburg-Vorpommern, 19053, Germany

Location

GSK Investigational Site

Bangalore, 560010, India

Location

GSK Investigational Site

Chennai, 600003, India

Location

GSK Investigational Site

Hyderabad, 500 034, India

Location

GSK Investigational Site

Tirupati, 517507, India

Location

GSK Investigational Site

Bialystok, 15-879, Poland

Location

GSK Investigational Site

Gdansk, 80-282, Poland

Location

GSK Investigational Site

Lublin, 20-442, Poland

Location

GSK Investigational Site

Skorzewo, 60-185, Poland

Location

GSK Investigational Site

Bratislava, 826 06, Slovakia

Location

GSK Investigational Site

Michalovce, 071 01, Slovakia

Location

GSK Investigational Site

Observatory ,Cape Town, 7925, South Africa

Location

GSK Investigational Site

Somerset West, 7140, South Africa

Location

GSK Investigational Site

Somerset West, 7500, South Africa

Location

GSK Investigational Site

Vereeniging, 1929, South Africa

Location

Related Publications (2)

• 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;

  BACKGROUND

• 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.

  PMID: 22048884 DERIVED

MeSH Terms

Conditions

Depressive Disorder; Depressive Disorder, Major

Interventions

GSK372475; Venlafaxine Hydrochloride

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Phenethylamines; Ethylamines; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Lipids

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2007
• First Posted: March 15, 2007
• Study Start: April 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: October 10, 2014

Record last verified: 2011-11

Locations

FI (2); FR (3); SL (2); BU (2); PL (4); CA (7); IN (4); BE (2); ES (3); AU (4); DE (5); ZA (4)