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
| العنوان: | 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 |
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| المؤلفون: | Stefano Zamuner, Ole Graff, Susan Marie Learned, Gary Evoniuk, Suraja Roychowdhury, Jack G. Modell, Rachel Moate, Emiliangelo Ratti, Robert L. Alexander, Graeme Archer, K. Ranga Rama Krishnan, Agnes Lavergne |
| المصدر: | Journal of Psychopharmacology. 26:653-662 |
| بيانات النشر: | SAGE Publications, 2011. |
| سنة النشر: | 2011 |
| مصطلحات موضوعية: | Adult, Male, Pharmacology, Placebo, Placebos, Norepinephrine (medication), Double-Blind Method, Dopamine, medicine, Humans, Neurotransmitter Uptake Inhibitors, Pharmacology (medical), Depressive Disorder, Major, Venlafaxine Hydrochloride, Cyclohexanols, medicine.disease, Antidepressive Agents, Clinical trial, Paroxetine, Psychiatry and Mental health, Tolerability, Major depressive disorder, Female, Serotonin, Psychology, Reuptake inhibitor, Follow-Up Studies, Tropanes, medicine.drug |
| الوصف: | GSK372475 is a triple reuptake inhibitor with approximately equipotent inhibition of serotonin, norepinephrine, and dopamine transporters. Two randomized, placebo- and active-controlled, double-blind studies examined the efficacy and safety of GSK372475 in outpatients (aged 18–64 years) with a diagnosis of major depressive episode associated with major depressive disorder (MDD). Patients were randomized 1:1:1 to placebo, GSK372475 (1–2 mg/d), or active control (Study 1: venlafaxine XR 150–225 mg/d; Study 2: paroxetine 20–30 mg/d). GSK372475 did not significantly differ from placebo on any of the key efficacy endpoints (six-item Bech scale, IDS-Clinician Rated, MADRS) in either study. Both active controls demonstrated significant antidepressant activity compared with placebo on both primary and secondary endpoints. The most common adverse effects (AEs) with GSK372475 were dry mouth, headache, insomnia, and nausea. AEs were more frequent for GSK372475 versus placebo for sleep, anxiety-related, gastrointestinal, and tachycardia events. Increases in mean change from baseline in heart rate and sitting blood pressure were greater for GSK372475 than observed for either placebo or active control groups. Completion rates were lower for GSK372475 (49%, 58%) compared with placebo (67%, 74%), venlafaxine XR (63%), or paroxetine (77%). GSK372475 was neither efficacious nor well tolerated in patients with MDD in two 10-week studies. |
| تدمد: | 1461-7285 0269-8811 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::eb401d02422f13cc84019627705bbe45 https://doi.org/10.1177/0269881111424931 |
| حقوق: | CLOSED |
| رقم الأكسشن: | edsair.doi.dedup.....eb401d02422f13cc84019627705bbe45 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 14617285 02698811 |
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