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A randomized, double-blind, placebo-controlled trial of desvenlafaxine succinate in the treatment of major depressive disorder.
Int Clin Psychopharmacol. 2007 Nov; 22(6):338-47.IC

Abstract

The antidepressant efficacy and safety of desvenlafaxine succinate (desvenlafaxine) were evaluated in a phase III, double-blind, placebo-controlled study. Outpatients with a primary diagnosis of major depressive disorder were treated with fixed once-daily doses of desvenlafaxine 200 or 400 mg for 8 weeks. The primary efficacy measure was change from baseline on the 17-item Hamilton Rating Scale for Depression. At the final on-therapy evaluation, adjusted mean change from baseline in 17-item Hamilton Rating Scale for Depression total score was greater for desvenlafaxine 200 and 400 mg/day vs. placebo. Both desvenlafaxine doses showed greater efficacy than placebo on the secondary efficacy measures, including the Clinical Global Impressions-Improvement scale scores, Montgomery-Asberg Depression Rating Scale scores, CGI-Severity, and 17-item Hamilton Rating Scale for Depression response rate. Desvenlafaxine 200 mg/day was also significantly better than placebo on remission, Visual Analog Scale-Pain Intensity overall scores, and some Visual Analog Scale-Pain Intensity subscale scores. Desvenlafaxine 400 mg/day was significantly better than placebo on selected Visual Analog Scale-Pain Intensity subscale scores. Most adverse events were mild or moderate in severity, and safety assessments revealed few clinically significant changes in vital signs, laboratory tests, and electrocardiogram results. These data provide support for the efficacy and safety of desvenlafaxine in the treatment of major depressive disorder.

Authors+Show Affiliations

Wyeth Research, Paris, France.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17917552

Citation

Septien-Velez, Lucia, et al. "A Randomized, Double-blind, Placebo-controlled Trial of Desvenlafaxine Succinate in the Treatment of Major Depressive Disorder." International Clinical Psychopharmacology, vol. 22, no. 6, 2007, pp. 338-47.
Septien-Velez L, Pitrosky B, Padmanabhan SK, et al. A randomized, double-blind, placebo-controlled trial of desvenlafaxine succinate in the treatment of major depressive disorder. Int Clin Psychopharmacol. 2007;22(6):338-47.
Septien-Velez, L., Pitrosky, B., Padmanabhan, S. K., Germain, J. M., & Tourian, K. A. (2007). A randomized, double-blind, placebo-controlled trial of desvenlafaxine succinate in the treatment of major depressive disorder. International Clinical Psychopharmacology, 22(6), 338-47.
Septien-Velez L, et al. A Randomized, Double-blind, Placebo-controlled Trial of Desvenlafaxine Succinate in the Treatment of Major Depressive Disorder. Int Clin Psychopharmacol. 2007;22(6):338-47. PubMed PMID: 17917552.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized, double-blind, placebo-controlled trial of desvenlafaxine succinate in the treatment of major depressive disorder. AU - Septien-Velez,Lucia, AU - Pitrosky,Bruno, AU - Padmanabhan,Sudharshan Krishna, AU - Germain,Jean-Michel, AU - Tourian,Karen A, PY - 2007/10/6/pubmed PY - 2008/1/15/medline PY - 2007/10/6/entrez SP - 338 EP - 47 JF - International clinical psychopharmacology JO - Int Clin Psychopharmacol VL - 22 IS - 6 N2 - The antidepressant efficacy and safety of desvenlafaxine succinate (desvenlafaxine) were evaluated in a phase III, double-blind, placebo-controlled study. Outpatients with a primary diagnosis of major depressive disorder were treated with fixed once-daily doses of desvenlafaxine 200 or 400 mg for 8 weeks. The primary efficacy measure was change from baseline on the 17-item Hamilton Rating Scale for Depression. At the final on-therapy evaluation, adjusted mean change from baseline in 17-item Hamilton Rating Scale for Depression total score was greater for desvenlafaxine 200 and 400 mg/day vs. placebo. Both desvenlafaxine doses showed greater efficacy than placebo on the secondary efficacy measures, including the Clinical Global Impressions-Improvement scale scores, Montgomery-Asberg Depression Rating Scale scores, CGI-Severity, and 17-item Hamilton Rating Scale for Depression response rate. Desvenlafaxine 200 mg/day was also significantly better than placebo on remission, Visual Analog Scale-Pain Intensity overall scores, and some Visual Analog Scale-Pain Intensity subscale scores. Desvenlafaxine 400 mg/day was significantly better than placebo on selected Visual Analog Scale-Pain Intensity subscale scores. Most adverse events were mild or moderate in severity, and safety assessments revealed few clinically significant changes in vital signs, laboratory tests, and electrocardiogram results. These data provide support for the efficacy and safety of desvenlafaxine in the treatment of major depressive disorder. SN - 0268-1315 UR - https://www.unboundmedicine.com/medline/citation/17917552/A_randomized_double_blind_placebo_controlled_trial_of_desvenlafaxine_succinate_in_the_treatment_of_major_depressive_disorder_ L2 - http://dx.doi.org/10.1097/YIC.0b013e3281e2c84b DB - PRIME DP - Unbound Medicine ER -