Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT00448058
Status:
COMPLETED
Last Update Posted:
2014-10-10
First Post:
2007-03-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study Of New Medicine (GSK 372475) For The Treatment Of Depression
Sponsor:
Organization:
Raw JSON
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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;'}, {'pmid': '22048884', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy, safety, and tolerability of GSK372475 compared with placebo in the treatment of outpatient subjects with Major Depressive Disorder (MDD)', 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Major depressive episode (MDE) associated with Major Depressive Disorder (DSM-IV-TR criteria)\n* Duration of current episode is at least 12 weeks duration and less than 2 years\n* Symptoms of decreased energy, pleasure, and interest\n* Female subjects who agree to use acceptable methods of birth control throughout the study\n\nExclusion criteria:\n\n* Current diagnosis of Panic Disorder, or symptoms of generalized anxiety or panic attacks that could interfere with their ability to complete the trial\n* Symptoms of MDE better accounted for by another diagnosis\n* Diagnosis of Bipolar, schizophrenia, other psychotic disorder(s), borderline or antisocial personality disorder, or dementia.\n* Started psychotherapy within 3 months prior to the Screening\n* Received electroconvulsive therapy or transcranial magnetic stimulation within 6 months prior to screening\n* Received psychoactive drugs within 4 weeks of randomization\n* Positive urine drug screen or positive blood alcohol\n* Suicidal risk or has had any previous suicide attempt, a family history of suicide attempt\n* Positive pregnancy test\n* History of seizure disorder, myocardial infarction (\\< 1yr), or unstable medical condition\n* 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