Abstract | OBJECTIVE: METHOD: Data were pooled from 2 randomized, double-blind, 8-week trials. One trial (conducted from January 2004 to October 2004) included patients with DSM-IV insomnia and comorbid MDD treated with fluoxetine concurrently with eszopiclone 3 mg/d or placebo. The other trial (conducted from July 2005 to April 2006) included patients with DSM-IV-TR insomnia and comorbid generalized anxiety disorder treated with escitalopram concurrently with eszopiclone 3 mg/d or placebo. Anxious depression was defined as a baseline 17-item Hamilton Depression Rating Scale (HDRS-17) score ≥ 14 (excluding insomnia items) and an anxiety/somatization factor score ≥ 7. Treatment group differences were determined for mean changes in HDRS-17 scores (with and without insomnia items), HDRS anxiety/somatization scores, and response and remission rates. Severity of insomnia was assessed by the Insomnia Severity Index (ISI). RESULTS: In the combined dataset, 347 of 1,136 patients (30.5%) had insomnia and comorbid anxious depression. Significant improvements in insomnia were observed for eszopiclone cotherapy relative to placebo cotherapy (mean change from baseline on the ISI: -11.0 vs -7.8, respectively; P < .001). There were greater reductions in HDRS-17 scores at week 8 following cotherapy with eszopiclone compared with placebo when the insomnia items were included (mean change: -14.1 vs -11.2, respectively; P < .01) or excluded (-10.6 vs -8.9; P < .01), but not for anxiety/somatization (-4.3 vs -4.1; P = .23). Response rates were greater for eszopiclone cotherapy than for placebo cotherapy (55.6% vs 42.0%, respectively; P = .01; 50.0% vs 44.4% when insomnia items were removed; P = .3). Remission rates were not significantly different (32.6% vs 27.2%, respectively; P = .28). CONCLUSIONS: In this post hoc analysis of patients with insomnia and comorbid anxious depression derived from 2 trials, 8 weeks of eszopiclone therapy coadministered with an SSRI resulted in significantly greater improvements in insomnia, significantly greater reductions in HDRS-17 total score, and significantly greater HDRS-17 response rates compared with placebo coadministration. There were no significant differences in response rates (when insomnia items were excluded) and remission rates, as well as in anxiety/somatization scores. Further research is warranted to determine whether these modest antidepressant effects can be replicated, and anxiolytic effects demonstrated, when evaluated in a prospective manner.
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Authors | Maurizio Fava, Kendyl Schaefer, Holly Huang, Amy Wilson, Dan V Iosifescu, David Mischoulon, Thomas C Wessel |
Journal | The Journal of clinical psychiatry
(J Clin Psychiatry)
Vol. 72
Issue 4
Pg. 473-9
(Apr 2011)
ISSN: 1555-2101 [Electronic] United States |
PMID | 21208574
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | © Copyright 2011 Physicians Postgraduate Press, Inc. |
Chemical References |
- Azabicyclo Compounds
- Hypnotics and Sedatives
- Piperazines
- Serotonin Uptake Inhibitors
- Fluoxetine
- Eszopiclone
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Topics |
- Adult
- Anxiety
(complications, drug therapy)
- Azabicyclo Compounds
(administration & dosage, therapeutic use)
- Depressive Disorder, Major
(complications, drug therapy)
- Double-Blind Method
- Drug Therapy, Combination
- Eszopiclone
- Female
- Fluoxetine
(administration & dosage, therapeutic use)
- Humans
- Hypnotics and Sedatives
(administration & dosage, therapeutic use)
- Male
- Piperazines
(administration & dosage, therapeutic use)
- Psychiatric Status Rating Scales
- Selective Serotonin Reuptake Inhibitors
(therapeutic use)
- Sleep Initiation and Maintenance Disorders
(complications, drug therapy)
- Treatment Outcome
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