Abstract
Objectives: Patients with major depressive disorder (MDD) and a comorbid anxiety disorder or significant anxiety symptoms have decreased functioning, increased risk of suicidality, and worse post-treatment outcomes. This pooled analysis of 8 duloxetine MDD trials was designed to determine whether early improvement in anxiety symptoms predicts MDD remission. Methods: Eight trials were pooled. Patients with a baseline 17-item Hamilton Rating Scale for Depression (HA-MD17) anxiety/somatization factor score ≥7 were considered to have anxious depression. Early response on the HAMD17 total score was defined as a 20% reduction at weeks 2 or 4, a 30% reduction at weeks 2 or 4, or a 50% reduction at weeks 2 or 4 in the HAMD17 anxiety subscale. Each category was analyzed separately for all patients. MDD remission is a score of ≤7 on the HAMD17 total score at study endpoint. Results: The early responder group in each analysis showed greater numerical improvement at endpoint on the HAMD17 total score than the nonresponder group. Duloxetine showed statistically significantly greater improvement than placebo in most nonresponder and responder subgroups. There were no statistically significant interaction effects for the difference between duloxetine and placebo for any of the anxious categories. Conclusion: Although patients who responded in the various response categories had greater numerical improvement and greater remission rates than nonresponding patients, the response and nonresponse groups did not differ statistically regarding the treatment effect of duloxetine. Therefore, early improvement in anxiety symptoms was not a predictor of greater endpoint remission of depressive symptoms for duloxetine treatment.
Highlights
Depression affects more than 350 million people worldwide and has a lifetime prevalence range of 10% to 15% (Lépine & Briley, 2011; World Health Organization, 2012)
Studies have shown that relapse rates are much higher in patients with partial remission than in those who experience complete remission (Bakish, 2001; Pintor, Gastó, Navarro, Torres, & Fañanas, 2003)
Data were pooled from 8 randomized, double-blind, placebo-controlled trials of duloxetine for the treatment of major depressive disorder (MDD) conducted by Eli Lilly and Company (Table 1)
Summary
Depression affects more than 350 million people worldwide and has a lifetime prevalence range of 10% to 15% (Lépine & Briley, 2011; World Health Organization, 2012). The percentage of people with MDD in the National Comorbidity Survey Replication study who were treated was only 51.6%; only 41.9% of those patients received adequate levels of treatment (Kessler et al, 2003). The majority of patients who are not adequately treated for their symptoms will relapse (Bakish, 2001). In the treatment of depression, early symptom improvement may be a clinically useful indicator for successful treatment or treatment failure (Nierenberg, Qyitkin, Kremer, Keller, & Thase, 2004; Wade & Friis Anderson, 2006). Some analyses have suggested that early drug-specific symptom improvement is predictive of greater overall response and symptom resolution at endpoint (Nierenberg et al, 2004; Wade & Friis Anderson, 2006)
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