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Analysis of individual items of the Hamilton depression scale in a study of eszopiclone/fluoxetine co-therapy

Published online by Cambridge University Press:  16 April 2020

P. Bech ,
A. Krystal ,
J. Walsh ,
R. Rubens ,
J. Caron ,
T. Wessel ,
D. Amato ,
T. Roth ,
W.V. McCall  and
M. Fava
P. Bech
Affiliation:
Psychiatric Research Unit, Frederiksborg General Hospital, Hillerod, Denmark
A. Krystal
Affiliation:
Duke University Medical Center, Durham, NC, USA
J. Walsh
Affiliation:
Sleep Medicine and Research Center, St. John's/St. Luke's Hospitals, St. Louis, MO, USA
R. Rubens
Affiliation:
Sepracor Inc., Marlborough, MA, USA
J. Caron
Affiliation:
Sepracor Inc., Marlborough, MA, USA
T. Wessel
Affiliation:
Sepracor Inc., Marlborough, MA, USA
D. Amato
Affiliation:
Sepracor Inc., Marlborough, MA, USA
T. Roth
Affiliation:
Henry Ford Sleep Disorders Center, Detroit, MI, USA
W.V. McCall
Affiliation:
Wake Forest University Health Sciences, Winston-Salem, NC, USA
M. Fava
Affiliation:
Massachusetts General Hospital, Boston, MA, USA

Abstract

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Background:

Results of a co-morbid insomnia and depression study of eszopiclone and fluoxetine demonstrated that co-therapy produced greater improvements in sleep and depression than fluoxetine monotherapy. To determine if changes in the HAMD17 were due to sleep, individual HAMD17 items were evaluated.

Methods:

Patients met DSM-IV criteria for MDD and insomnia, with screening HAMD17 >14. All patients received fluoxetine QAM for 10 weeks, and randomly received double-blind eszopiclone 3mg or placebo QHS for 8 weeks, followed by a single-blind placebo 2-week run-out. HAMD17 was completed at Weeks 4, 8, and 10. Individual items were compared with ANCOVA using an LOCF approach.

Results:

Mean baseline HAMD17 scores were 22 for each group. At Week 4, differences were noted between treatment groups in the total score, and the individual items of insight, the three insomnia items (p<0.02 vs monotherapy), with a trend for guilt (p=0.07). At Week 8, significant differences between groups were noted in total score (p=0.0005), in the clinician-administered Bech subscale (p<0.001), in the three insomnia items (p<0.001), guilt, work/activities, and anxiety psychic (p<0.05). At Week 10, the total score, guilt, the three insomnia items, work/activities, retardation, agitation, anxiety psychic, general somatic symptoms, and hypochondriasis demonstrated significant improvements (p<0.05 vs monotherapy) despite discontinuation of eszopiclone.

Conclusions:

Eszopiclone/fluoxetine co-therapy resulted in significant improvements in the insomnia items of the HAMD17. In addition, several items related to core depressive symptoms were also improved with co-therapy compared with monotherapy.

Support for this study provided by Sepracor Inc.

Type
Poster Session 2: Depressive Disorders
Information
European Psychiatry , Volume 22 , Issue S1: 15th AEP Congress - Abstract book - 15th AEP Congress , March 2007 , pp. S224
Copyright
Copyright © European Psychiatric Association 2007
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