Abstract
BackgroundRelapse 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.MethodsA 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.ResultsThe 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.ConclusionThe 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 RegistrationClinicalTrials.gov Identifier: NCT00427128
Highlights
Relapse of major depressive disorder (MDD) is a common clinical problem
Patients were excluded from the study if they were at significant risk of suicide; were pregnant or breastfeeding, were women not using effective contraception; had an unstable physical disorder; had a lifetime history of any organic mental disorder, psychotic disorder, or mania; had a history of seizures; had a neurological disorder that significantly affects central nervous system (CNS) function; had met criteria for substance abuse or dependence in the previous 6 months, other than nicotine dependence; were taking medications that may cause or exacerbate depression; had clinical or laboratory evidence of hypothyroidism without adequate and stable replacement therapy; or had a history of nonresponse to an adequate trial of a selective serotonin reuptake inhibitor (SSRI)
The results of the present analysis do not suggest that a greater burden of residual sleep disturbance is associated with a higher risk of relapse among fluoxetine responders with MDD during the continuation/maintenance phase of treatment with either fluoxetine or placebo
Summary
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. Dombrovski and colleagues [27], for instance, used data from a clinical trial of maintenance treatment of late-life depression to analyze the impact of overall residual symptom levels as well as specific residual depressive symptom clusters on depressive recurrence Both residual anxiety and residual sleep disturbance were found to be significant independent predictors of early recurrence across treatment groups. One Sequenced Treatment Alternatives to Relieve Depression (STAR*D) report [28] suggests that the association between residual sleep disturbance and MDD recurrence is far from being fully understood For this reason, there is the need for more studies examining the role of residual sleep disturbance as a predictor of relapse in MDD
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