drugset / Trial / NCT00235508
Safety and Efficacy of Eszopiclone in Patients With Generalized Anxiety Disorder
RandomizedParallel-groupTriple-blindTreatment
Summary
To determine the safety and efficacy of eszopiclone as adjunctive therapy in the treatment of insomnia in patients with insomnia related to Generalized Anxiety Disorder. All subjects will receive an approved anxiolytic agent and will be randomized to nightly therapy with either eszopiclone or placebo.
Timeline
- Start
- 2005-06
- Primary completion
- 2006-04
- Completion
- 2006-04
Publications
- Results Fava M, Schaefer K, Huang H, Wilson A, Iosifescu DV, Mischoulon D, Wessel TC. A post hoc analysis of the effect of nightly administration of eszopiclone and a selective serotonin reuptake inhibitor in patients with insomnia and anxious depression. J Clin Psychiatry. 2011 Apr;72(4):473-9. doi: 10.4088/JCP.09m05131gry. Epub 2010 Nov 2.
- Pollack M, Kinrys G, Krystal A, McCall WV, Roth T, Schaefer K, Rubens R, Roach J, Huang H, Krishnan R. Eszopiclone coadministered with escitalopram in patients with insomnia and comorbid generalized anxiety disorder. Arch Gen Psychiatry. 2008 May;65(5):551-62. doi: 10.1001/archpsyc.65.5.551.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Eszopiclone | Small molecule | 3 mg | — |