Efficacy and safety of desvenlafaxine 25 and 50 Mg/Day in a randomized, placebo-controlled study of depressed outpatients

Nakao Iwata, Karen A. Tourian, Eunhee Hwang, Linda Mele, Cecile Vialet

Research output: Contribution to journalArticle

36 Citations (Scopus)

Abstract

Background. This study evaluated the efficacy and safety of low-dose desvenlafaxine (administered as desvenlafaxine succinate) in treating major depressive disorder (MDD). Methods. Adult outpatients (aged 18 years) in the United States and (aged 20 years) in Japan, who met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria for MDD and had a 17-item Hamilton Depression Rating Scale (HAM-D17) score 20, were ran-domly assigned to placebo, low-dose desvenlafaxine (25 mg/day), or the recommended dose (50 mg/day) after a 6to 14-day placebo lead-in, in an 8-week, fixed-dose trial. The primary efficacy variable was change from baseline in HAMD17 total score at final on-therapy evaluation. Efficacy analyses were based on the intent-totreat (ITT) population, using the last observation carried forward. Results. The ITT population included 699 patients. Reduction in HAM-D17 scores from baseline to final evaluation was not significantly greater for desvenlafaxine 25 mg/day (-8.98) but was significantly greater for desvenlafaxine 50 mg/day (-10.02; P = 0.016) versus placebo (-8.52) after adjusting for multiplicity. P-values were < 0.05 versus placebo for percentage of patients responding to treatment ( 50% decrease in HAM-D17 score) with desven-lafaxine 50 mg/day (46%; P = 0.015), but not with desvenlafaxine 25 mg/day (42% versus 35% with placebo). P-values for remission rates (HAM-D17 score ≤ 7) were not < 0.05 versus placebo for either desvenlafaxine treatment group. Discontinuations due to adverse events were observed in 2.6%, 3.4%, and 3.4% of patients treated with placebo, desvenlafaxine 25 mg/day, and desvenlafaxine 50 mg/day, respectively. Conclusions. Consistent with other clinical studies, desvenlafaxine 50 mg/day demonstrated antidepressant efficacy and appears to be the minimally effective dosage for MDD.

Original languageEnglish
Pages (from-to)5-14
Number of pages10
JournalJournal of Psychiatric Practice
Volume19
Issue number1
DOIs
Publication statusPublished - 01-01-2013

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Outpatients
Placebos
Safety
Major Depressive Disorder
Desvenlafaxine Succinate
Diagnostic and Statistical Manual of Mental Disorders
Antidepressive Agents
Population
Japan
Therapeutics
Observation
Depression

All Science Journal Classification (ASJC) codes

  • Psychiatry and Mental health

Cite this

Iwata, Nakao ; Tourian, Karen A. ; Hwang, Eunhee ; Mele, Linda ; Vialet, Cecile. / Efficacy and safety of desvenlafaxine 25 and 50 Mg/Day in a randomized, placebo-controlled study of depressed outpatients. In: Journal of Psychiatric Practice. 2013 ; Vol. 19, No. 1. pp. 5-14.
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abstract = "Background. This study evaluated the efficacy and safety of low-dose desvenlafaxine (administered as desvenlafaxine succinate) in treating major depressive disorder (MDD). Methods. Adult outpatients (aged 18 years) in the United States and (aged 20 years) in Japan, who met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria for MDD and had a 17-item Hamilton Depression Rating Scale (HAM-D17) score 20, were ran-domly assigned to placebo, low-dose desvenlafaxine (25 mg/day), or the recommended dose (50 mg/day) after a 6to 14-day placebo lead-in, in an 8-week, fixed-dose trial. The primary efficacy variable was change from baseline in HAMD17 total score at final on-therapy evaluation. Efficacy analyses were based on the intent-totreat (ITT) population, using the last observation carried forward. Results. The ITT population included 699 patients. Reduction in HAM-D17 scores from baseline to final evaluation was not significantly greater for desvenlafaxine 25 mg/day (-8.98) but was significantly greater for desvenlafaxine 50 mg/day (-10.02; P = 0.016) versus placebo (-8.52) after adjusting for multiplicity. P-values were < 0.05 versus placebo for percentage of patients responding to treatment ( 50{\%} decrease in HAM-D17 score) with desven-lafaxine 50 mg/day (46{\%}; P = 0.015), but not with desvenlafaxine 25 mg/day (42{\%} versus 35{\%} with placebo). P-values for remission rates (HAM-D17 score ≤ 7) were not < 0.05 versus placebo for either desvenlafaxine treatment group. Discontinuations due to adverse events were observed in 2.6{\%}, 3.4{\%}, and 3.4{\%} of patients treated with placebo, desvenlafaxine 25 mg/day, and desvenlafaxine 50 mg/day, respectively. Conclusions. Consistent with other clinical studies, desvenlafaxine 50 mg/day demonstrated antidepressant efficacy and appears to be the minimally effective dosage for MDD.",
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Efficacy and safety of desvenlafaxine 25 and 50 Mg/Day in a randomized, placebo-controlled study of depressed outpatients. / Iwata, Nakao; Tourian, Karen A.; Hwang, Eunhee; Mele, Linda; Vialet, Cecile.

In: Journal of Psychiatric Practice, Vol. 19, No. 1, 01.01.2013, p. 5-14.

Research output: Contribution to journalArticle

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T1 - Efficacy and safety of desvenlafaxine 25 and 50 Mg/Day in a randomized, placebo-controlled study of depressed outpatients

AU - Iwata, Nakao

AU - Tourian, Karen A.

AU - Hwang, Eunhee

AU - Mele, Linda

AU - Vialet, Cecile

PY - 2013/1/1

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N2 - Background. This study evaluated the efficacy and safety of low-dose desvenlafaxine (administered as desvenlafaxine succinate) in treating major depressive disorder (MDD). Methods. Adult outpatients (aged 18 years) in the United States and (aged 20 years) in Japan, who met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria for MDD and had a 17-item Hamilton Depression Rating Scale (HAM-D17) score 20, were ran-domly assigned to placebo, low-dose desvenlafaxine (25 mg/day), or the recommended dose (50 mg/day) after a 6to 14-day placebo lead-in, in an 8-week, fixed-dose trial. The primary efficacy variable was change from baseline in HAMD17 total score at final on-therapy evaluation. Efficacy analyses were based on the intent-totreat (ITT) population, using the last observation carried forward. Results. The ITT population included 699 patients. Reduction in HAM-D17 scores from baseline to final evaluation was not significantly greater for desvenlafaxine 25 mg/day (-8.98) but was significantly greater for desvenlafaxine 50 mg/day (-10.02; P = 0.016) versus placebo (-8.52) after adjusting for multiplicity. P-values were < 0.05 versus placebo for percentage of patients responding to treatment ( 50% decrease in HAM-D17 score) with desven-lafaxine 50 mg/day (46%; P = 0.015), but not with desvenlafaxine 25 mg/day (42% versus 35% with placebo). P-values for remission rates (HAM-D17 score ≤ 7) were not < 0.05 versus placebo for either desvenlafaxine treatment group. Discontinuations due to adverse events were observed in 2.6%, 3.4%, and 3.4% of patients treated with placebo, desvenlafaxine 25 mg/day, and desvenlafaxine 50 mg/day, respectively. Conclusions. Consistent with other clinical studies, desvenlafaxine 50 mg/day demonstrated antidepressant efficacy and appears to be the minimally effective dosage for MDD.

AB - Background. This study evaluated the efficacy and safety of low-dose desvenlafaxine (administered as desvenlafaxine succinate) in treating major depressive disorder (MDD). Methods. Adult outpatients (aged 18 years) in the United States and (aged 20 years) in Japan, who met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria for MDD and had a 17-item Hamilton Depression Rating Scale (HAM-D17) score 20, were ran-domly assigned to placebo, low-dose desvenlafaxine (25 mg/day), or the recommended dose (50 mg/day) after a 6to 14-day placebo lead-in, in an 8-week, fixed-dose trial. The primary efficacy variable was change from baseline in HAMD17 total score at final on-therapy evaluation. Efficacy analyses were based on the intent-totreat (ITT) population, using the last observation carried forward. Results. The ITT population included 699 patients. Reduction in HAM-D17 scores from baseline to final evaluation was not significantly greater for desvenlafaxine 25 mg/day (-8.98) but was significantly greater for desvenlafaxine 50 mg/day (-10.02; P = 0.016) versus placebo (-8.52) after adjusting for multiplicity. P-values were < 0.05 versus placebo for percentage of patients responding to treatment ( 50% decrease in HAM-D17 score) with desven-lafaxine 50 mg/day (46%; P = 0.015), but not with desvenlafaxine 25 mg/day (42% versus 35% with placebo). P-values for remission rates (HAM-D17 score ≤ 7) were not < 0.05 versus placebo for either desvenlafaxine treatment group. Discontinuations due to adverse events were observed in 2.6%, 3.4%, and 3.4% of patients treated with placebo, desvenlafaxine 25 mg/day, and desvenlafaxine 50 mg/day, respectively. Conclusions. Consistent with other clinical studies, desvenlafaxine 50 mg/day demonstrated antidepressant efficacy and appears to be the minimally effective dosage for MDD.

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