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
Verified date | November 2011 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To evaluate the efficacy, safety, and tolerability of GSK372475 compared with placebo in the treatment of outpatient subjects with Major Depressive Disorder (MDD)
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
Australia, Belgium, Bulgaria, Canada, Estonia, Finland, France, Germany, India, Poland, Slovakia, South Africa,
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
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) |
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