Jean Endicott1, Raymond W Lam2, Ming-Ann Hsu3, Rana Fayyad4, Matthieu Boucher5, Christine J Guico-Pabia6. 1. Columbia University Medical Center, New York State Psychiatric Institute, 1051 Riverside Drive, New York, NY 10032, USA. Electronic address: je10@columbia.edu. 2. University of British Columbia, Vancouver, Canada. 3. Pfizer Inc, Groton, CT, USA. 4. Pfizer Inc, New York, NY, USA. 5. Pfizer Canada Inc., Kirkland, Canada. 6. Metagenics, Inc, USA.
Abstract
BACKGROUND: Diminished quality of life (QOL) is associated with major depressive disorder (MDD). METHODS:QOL was assessed in a post-hoc analysis of a double-blind, placebo-controlled trial. Employed adult outpatients with MDD were randomly assigned to 12 weeks of treatment with desvenlafaxine 50mg/d or placebo. Changes from baseline in the Short Form of the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) item scores at week 12 were analyzed using analysis of covariance with treatment, region, and baseline in the model. Correlations between change from baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D17) total score and Q-LES-Q scores were computed. RESULTS: The intent-to-treat population included 427 patients. There were statistically significant improvements from baseline for desvenlafaxine vs placebo in 10 of 16 Q-LES-Q item scores (P values ≤0.0441). The percentage of patients with severe QOL impairment (≥2 SD below community norm) at week 12 was significantly lower for desvenlafaxine (46%) vs placebo (62%; P=0.0024; baseline: 95% and 94%, respectively). Change in Q-LES-Q total score was highly correlated with change in HAM-D17 score at week 12, LOCF (P<0.0001), and improvement in HAM-D17 total score at week 2 predicted change in Q-LES-Q total score at week 12 for the desvenlafaxine group (F=24.89; P<0.0001) but not placebo. LIMITATIONS: This analysis excluded patients who were unemployed, had severe comorbidities, and those taking multiple, concomitant medications. CONCLUSION: Improvement in QOL and depressive symptoms was significantly greater for employed depressed patients treated with desvenlafaxine vs placebo.
RCT Entities:
BACKGROUND: Diminished quality of life (QOL) is associated with major depressive disorder (MDD). METHODS: QOL was assessed in a post-hoc analysis of a double-blind, placebo-controlled trial. Employed adult outpatients with MDD were randomly assigned to 12 weeks of treatment with desvenlafaxine 50mg/d or placebo. Changes from baseline in the Short Form of the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) item scores at week 12 were analyzed using analysis of covariance with treatment, region, and baseline in the model. Correlations between change from baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D17) total score and Q-LES-Q scores were computed. RESULTS: The intent-to-treat population included 427 patients. There were statistically significant improvements from baseline for desvenlafaxine vs placebo in 10 of 16 Q-LES-Q item scores (P values ≤0.0441). The percentage of patients with severe QOL impairment (≥2 SD below community norm) at week 12 was significantly lower for desvenlafaxine (46%) vs placebo (62%; P=0.0024; baseline: 95% and 94%, respectively). Change in Q-LES-Q total score was highly correlated with change in HAM-D17 score at week 12, LOCF (P<0.0001), and improvement in HAM-D17 total score at week 2 predicted change in Q-LES-Q total score at week 12 for the desvenlafaxine group (F=24.89; P<0.0001) but not placebo. LIMITATIONS: This analysis excluded patients who were unemployed, had severe comorbidities, and those taking multiple, concomitant medications. CONCLUSION: Improvement in QOL and depressive symptoms was significantly greater for employed depressedpatients treated with desvenlafaxine vs placebo.
Authors: Anna J Swan; Philip C Kendall; Thomas Olino; Golda Ginsburg; Courtney Keeton; Scott Compton; John Piacentini; Tara Peris; Dara Sakolsky; Boris Birmaher; Anne Marie Albano Journal: J Consult Clin Psychol Date: 2018-09
Authors: Emma Morton; Venkat Bhat; Peter Giacobbe; Wendy Lou; Erin E Michalak; Shane McInerney; Trisha Chakrabarty; Benicio N Frey; Roumen V Milev; Daniel J Müller; Sagar V Parikh; Susan Rotzinger; Sidney H Kennedy; Raymond W Lam Journal: CNS Drugs Date: 2021-04-16 Impact factor: 5.749