Abstract
Background: Relapse of major depressive disorder (MDD) is a common clinical problem. This study was designed to determine whether residual sleep disturbance (insomnia and hypersomnia) predict risk of relapse during the continuation and maintenance treatment of MDD.Methods: A total of 570 patients with MDD were treated with open-label, flexible dose fluoxetine (range 20 to 60 mg; mean dose = 45.8 mg/day; SD = 15.1) for 12 weeks. Under double blind conditions, 262 patients who achieved clinical response were randomly assigned to continue fluoxetine or to switch to placebo for 52 weeks or until relapse. Residual sleep disturbance during the baseline visit of the double-blind phase was assessed using items 4, 5, 6 (insomnia) and 22, 23, 24 (hypersomnia) of the Hamilton Depression Rating Scale (HDRS). Survival analysis was utilized to determine the effect of residual sleep disturbance on risk of relapse.Results: The severities of early (P > 0.05), middle (P > 0.05), late (P > 0.05), or total (P > 0.05) residual insomnia were not found to significantly predict risk of relapse during continuation and maintenance-phase treatment. Similarly, the severities of early bedtime (P > 0.05), oversleeping (P > 0.05), napping (P > 0.05), or total (P > 0.05) residual hypersomnia were not found to significantly predict risk of relapse during continuation and maintenance-phase treatment.Conclusion: The present study did not identify the severity of residual sleep disturbance among fluoxetine responders to predict risk of MDD relapse. The size of our sample may have precluded us from identifying more modest effects of residual sleep disturbance on the risk of relapse in MDD patients. Future studies are needed to further explore the relationship between residual sleep disturbance and relapse in MDD.Trial Registration: ClinicalTrials.gov Identifier: NCT00427128.
| Original language | English (US) |
|---|---|
| Article number | 10 |
| Journal | Annals of General Psychiatry |
| Volume | 9 |
| DOIs | |
| State | Published - Feb 26 2010 |
Funding
HY, LSY, SC, SJY, YC, AC, and LB declare that they have no competing interests. PJM has received research support from the National Institute of Mental Health, National Institute on Alcohol Abuse and Alcoholism, New York State Department of Mental Hygiene, NARSAD, Research Foundation for Mental Hygiene (New York State), GlaxoSmithKline, Eli Lilly, Organon and Lipha Pharmaceuticals, and has worked in an advisory/consulting capacity for GlaxoSmithKline, Somerset Pharmaceuticals, Novartis Pharmaceuticals (2008), Sanofi Aventis (2007) and Roche (2008), MF has received research support from Abbott Laboratories, Alkermes, Aspect Medical Systems, Astra-Zeneca, Bristol-Myers Squibb Company, Cephalon, Eli Lilly & Company, Forest Pharmaceuticals Inc., GlaxoSmithKline, J & J Pharmaceuticals, Lichtwer Pharma GmbH, Lorex Pharmaceuticals, Novartis, Organon Inc., PamLab, LLC, Pfizer Inc, Pharmavite, Roche, Sanofi Aventis, Solvay Pharmaceuticals, Inc. and Synthelabo, Wyeth-Ayerst Laboratories, has worked in an advisory/consulting capacity for Abbott Laboratories, Amarin, Aspect Medical Systems, Astra-Zeneca, Auspex Pharmaceuticals, Bayer AG, Best Practice Project Management, Inc., Biovail Pharmaceuticals, Inc., BrainCells, Inc. Bristol-Myers Squibb Company, Cephalon, CNS Response, Compellis, Cypress Pharmaceuticals, Dov Pharmaceuticals, Eli Lilly & Company, EPIX Pharmaceuticals, Fabre-Kramer Pharmaceuticals, Inc., Forest Pharmaceuticals Inc., GlaxoSmithKline, Grunenthal GmBH, Janssen Pharmaceutica, Jazz Pharmaceuticals, J & J Pharmaceuticals, Knoll Pharmaceutical Company, Lorex Pharmaceuticals, Lundbeck, MedAvante, Inc., Merck, Neuronetics, Novartis, Nutrition 21, Organon Inc., PamLab, LLC, Pfizer Inc, PharmaStar, Pharmavite, Precision Human Biolaboratory, Roche, Sanofi Aventis, Sepracor, Solvay Pharmaceuticals, Inc., Somaxon, Somerset Pharmaceuticals, Synthelabo, Takeda, Tetragenex, Transcept Pharmaceuticals, Vanda Pharmaceuticals Inc, Wyeth-Ayerst Laboratories, has been a speaker for Astra-Zeneca, Boehringer-Ingelheim, Bristol-Myers Squibb Company, Cephalon, Eli Lilly & Company, Forest Pharmaceuticals Inc., GlaxoSmithKline, Novartis, Organon Inc., Pfizer Inc, PharmaStar, Primedia, Reed-Elsevier and Wyeth-Ayerst Laboratories, has equity holdings in Compellis and MedAvante, and has the following royalties/patents or other income: patent applications for SPCD and for a combination of azapirones and bupropion in MDD, copyright royalties for the MGH CPFQ, DESS, and SAFER. GIP has served as a consultant to Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Evotec, Inflabloc Pharmaceuticals, Jazz Pharmaceuticals, Pamlab, Pfizer, Pierre Fabre, Shire and Wyeth, has received honoraria from Bristol-Myers Squibb, Eli Lilly, Evotec, GlaxoSmithKline, Inflabloc Pharmaceuticals, Jazz Pharmaceuticals, Lundbeck, Pamlab, Pfizer, Pierre Fabre, Shire, Titan Pharmaceuticals and Wyeth, has received research support from Bristol-Myers Squibb, Forest, National Institute of Mental Health, Pamlab, Pfizer and Precision Human Biolaboratories, and has served on the speakers bureau for Bristol-Myers Squibb and Pfizer.
ASJC Scopus subject areas
- Psychiatry and Mental health