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Objective: This study evaluates the efficacy of agomelatine, the first antidepressant to be an agonist at MT1/MT2 receptors and an antagonist at 5-HT2C receptors, versus sertraline with regard to the amplitude of the circadian rest-activity cycle and depressive and anxiety symptoms in patients with major depressive disorder (MDD).
Method: Outpatients with DSM-IV-TR-defined MDD received either agomelatine 25 to 50 mg (n' ‰=' ‰154) or sertraline 50 to 100 mg (n' ‰=' ‰159) during a 6-week, randomized, double-blind treatment period. The study was conducted from 2005 to 2006. The main outcome measure was the relative amplitude of the individual rest-activity cycles, expressed as change from baseline to week 6 and collected from continuous records using wrist actigraphy and sleep logs. Secondary outcome measures were sleep efficiency and sleep latency, both derived from actigraphy, and efficacy on depression symptoms (17-Item Hamilton Depression Rating Scale total score and Clinical Global Impressions scale scores) and anxiety symptoms (Hamilton Anxiety Rating Scale total score and subscores).
Results: A significant difference in favor of agomelatine compared to sertraline on the relative amplitude of the circadian rest-activity cycle was observed at the end of the first week (P' ‰=' ‰.01). In parallel, a significant improvement of sleep latency (P' ‰<' ‰.001) and sleep efficiency (P' ‰<' ‰.001) from week 1 to week 6 was observed with agomelatine as compared to sertraline. Over the 6-week treatment period, depressive symptoms improved significantly more with agomelatine than with sertraline (P' ‰<' ‰.05), as did anxiety symptoms (P' ‰<' ‰.05).
Conclusions: The favorable effect of agomelatine on the relative amplitude of the circadian rest-activity/sleep-wake cycle in depressed patients at week 1 reflects early improvement in sleep and daytime functioning. Higher efficacy results were observed with agomelatine as compared to sertraline on both depressive and anxiety symptoms over the 6-week treatment period, together with a good tolerability profile. These findings indicate that agomelatine offers promising benefits for MDD patients.
Trial Registration: www.isrctn.org: ISRCTN49376288
Introduction: Agitation is common in dementia and is associated with use of restraints and use of psychotropic drugs. The aim of this study was to determine whether an education and supervision intervention could reduce agitation and the use of restraints and antipsychotic drugs in nursing homes.
Method: Four Norwegian nursing homes were randomly allocated to receive either treatment as usual or an intervention consisting of a 2-day educational seminar and monthly group guidance for 6 months. One hundred forty-five residents with dementia (based on medical records and corroborated with a Functional Assessment Staging score' ‰≥' ‰4) completed baseline and 6-month intervention assessments and were included in the analyses. The co-primary outcome measures were the proportion of residents subject to interactional restraint and the severity of agitation using the Cohen-Mansfield Agitation Inventory (CMAI). Patients were assessed at baseline, immediately after completion of the intervention at 6 months, and 12 months after baseline. Comparison of change in the 2 groups was made using repeated-measures analysis of variance (CMAI) and Mann-Whitney test (restraints). The study was conducted from 2003 to 2004.
Results: The proportion of residents starting new restraint was lower in the intervention than in the control group at 6-month evaluation (P' ‰=' ‰.02), but no statistically significant differences were found at 12-month assessment (P' ‰=' ‰.57). The total CMAI score declined from baseline to 6 and 12 months' follow-up in the intervention homes compared to a small increase in the control homes (F2,176' ‰=' ‰3.46, P' ‰=' ‰.034). There were no statistically significant differences in use of antipsychotic drugs.
Conclusions: A brief 2-day staff education program followed by continued monthly guidance was able both to improve quality of care by reducing the frequency of interactional restraints and to reduce severity of agitation.
Submitted: June 18, 2009; accepted September 23, 2009
Corresponding author: Ingelin Testad, RN, Psychiatric Clinic, Stavanger University Hospital, PO Box 8100, 4068 Stavanger, Norway ([email protected]).
Objective: Treatment of excessive sleepiness in the context of obstructive sleep apnea (OSA) may be particularly difficult in those with depression because depression and/or antidepressant medications may cause sleepiness and fatigue in addition to that due to the OSA. This study evaluating armodafinil, a nonamphetamine wakefulness-promoting medication, is the first trial for treatment of excessive sleepiness in patients with treated OSA and comorbid depression.
Method: Men and women with OSA diagnosed using International Classification of Sleep Disorders criteria being treated with continuous positive airway pressure and comorbid major depressive disorder or dysthymic disorder according to DSM-IV-TR criteria were enrolled into a 12-week, randomized, double-blind, parallel-group study between September 2007 and March 2009 at 60 outpatient sites. Patients maintained on stable monotherapy with a serotonergic antidepressant and with a 17-item Hamilton Depression Rating Scale score <' ‰17 received placebo or armodafinil (target dose: 200 mg once daily). Coprimary outcomes were the proportion of patients with at least minimal improvement on the Clinical Global Impression of Change (CGI-C) as related to excessive sleepiness and mean change from baseline in Maintenance of Wakefulness Test mean sleep latency at final visit; the key secondary outcome was mean change in the Epworth Sleepiness Scale score.
Results: 249 patients were enrolled: 125 in the armodafinil group and 124 in the placebo group. The proportion of patients with at least minimal improvement on the CGI-C was statistically significantly greater in the armodafinil group (69%) compared with the placebo group (53%, P' ‰=' ‰.012). Mean (SD) increase in Maintenance of Wakefulness Test sleep latency was numerically but not significantly greater following armodafinil (2.6 [7.1] min) versus placebo (1.1 [7.6] min, P' ‰=' ‰.30) treatment. Mean decrease in Epworth Sleepiness Scale score was greater in the armodafinil group (-6.3 [4.8]) than in the placebo group (-4.8 [4.9], nominal P' ‰=' ‰.003). Headache, dry mouth, and insomnia were the most common adverse events occurring with armodafinil treatment. There was no clinically significant effect on depression in either group as measured by the Quick Inventory of Depressive Symptomatology-Self-Report 16.
Conclusions: Armodafinil significantly improved overall clinical condition related to excessive sleepiness as rated by the CGI-C and was well tolerated in patients with treated OSA and comorbid depression.
Trial Registration: clinicaltrials.gov Identifier: NCT00518986
Submitted: July 16, 2009; accepted October 30, 2009.
Online ahead of print: December 29, 2009
Corresponding author: Andrew D. Krystal, MD, Duke University Medical Center, Department of Psychiatry and Behavioral Sciences, Duke Clinic, 200 Trent Dr, 4th Fl, White Zone, Durham, NC 27710 ([email protected]).
Objective: This review aims to impart information regarding recognition of obstructive sleep apnea (OSA) and associated excessive sleepiness (ES) in the primary care setting in order to provide optimal care to patients with this common but serious condition. This review will also discuss the prevalence and treatment of depression in patients with OSA.
Data Sources: A MEDLINE search of articles published between 1990 and 2008 was conducted using the search terms obstructive sleep apnea AND excessive sleepiness, obstructive sleep apnea AND depression, and obstructive sleep apnea AND primary care. Searches were limited to articles in English concerned with adult patients.
Study Selection: In total, 239 articles were identified. Articles concerning other sleep disorders and forms of apnea were excluded. The reference lists of identified articles were searched manually to find additional articles of interest.
Data Synthesis: Primary care physicians can aid in the diagnosis of OSA and associated ES by being vigilant for lifestyle and physical risk factors associated with this condition. In addition, primary care physicians should maintain a high level of clinical suspicion when presented with illnesses that are commonly comorbid with OSA, such as psychiatric disorders and depression, in particular. Conversely, assessment of patients with OSA for common comorbidities may also improve a patient's prognosis and quality of life.
Conclusions: Primary care physicians play a vital role in recognizing OSA and ES. These clinicians are crucial in supporting their patients during treatment by ensuring that they have clear, concise information regarding available therapies and the correct application and maintenance of prescribed devices.
Letter to the Editor
Somatic symptoms are the foremost reason that individuals seek medical care, and most patients present with these symptoms in the primary care setting. Thus, clinicians must be able to recognize the manifestations of chronic pain as well as devise and implement an individualized treatment strategy that will relieve pain, manage any psychiatric comorbidities, and improve functioning and quality of life. This video includes 3 example patient cases and expert recommendations on accurately identifying, diagnosing, and treating the illnesses related to chronic pain, including comorbid depression and anxiety.
Background:Excessive sleepiness often goes unrecognized in the primary care setting despite its high prevalence and deleterious effects on both individual and public safety. Patients with neurologic and psychiatric illnesses, as well as those with acute and chronic medical conditions, plus those with sleep disorders, often have symptoms of excessive sleepiness, tiredness, and fatigue. Recognition and prompt treatment of these symptoms are important, even though their etiology may not be immediately understood. This review focuses on the underlying causes, consequences, identification, and treatment of excessive sleepiness.
Data Sources: A search of the literature to 2007 was performed using the PubMed search engine. English-language articles were identified using the following search terms: excessive sleepiness, fatigue, circadian rhythm, obstructive sleep apnea, shift work disorder, narcolepsy, drowsy driving, and wakefulness. Additional references were identified through bibliography reviews of relevant articles.
Data Synthesis:Current assessments of the prevalence, consequences, and etiologies of excessive sleepiness, with leading treatment strategies, were extracted, reviewed, and summarized to meet the objectives of this article.
Conclusions: Excessive sleepiness is associated with a wide range of medical, neurologic, and psychiatric disorders frequently seen in primary care practice. Excessive sleepiness is a serious, debilitating, potentially life-threatening condition, yet also treatable, and it is important to initiate appropriate intervention as early as possible. Physicians should place increasing emphasis on the substantial benefits that accompany improvements in wakefulness.
Capgras Syndrome in a Patient With Multiple Sclerosis: A Case Report
Objective: To investigate the efficacy of duloxetine in the treatment of pain and improvement in functional impairment and quality of life in patients with fibromyalgia from a pooled analysis of 4 placebo-controlled, double-blind, randomized trials.
Method: Patients were eligible for inclusion in the studies if they were at least 18 years of age, met criteria for fibromyalgia as defined by the American College of Rheumatology, and had specified minimum pain severity scores. Across all studies, 797 patients received duloxetine 60-120 mg/d and 535 patients received placebo. Pain was assessed by the Brief Pain Inventory (BPI) 24-hour average pain severity score; other efficacy measures included the Clinical Global Impressions-Severity of Illness scale (CGI-S), Patient Global Impressions-Improvement scale (PGI-I), 17-item Hamilton Depression Rating Scale (HDRS-17), Fibromyalgia Impact Questionnaire (FIQ) total score, BPI pain interference items, Sheehan Disability Scale (SDS), and Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) mental and physical components. Changes from baseline to endpoint (last observation carried forward) for most of the above efficacy measures were analyzed using an analysis-of-covariance model.
Results: After 12 weeks of treatment, pain was significantly reduced in patients treated with duloxetine (P < .001) compared with placebo. In addition, duloxetine was superior to placebo in improving CGI-S (P < .001); PGI-I (P < .001); FIQ total (P < .001); HDRS-17 total (P = .003); SDS global functioning (P < .001), work/school (P = .018), and family life (P < .001); SF-36 mental (P < .001) and physical (P = .026) component; and BPI pain interference (P < .001) scores. Treatment-by-subgroup interactions were not significant for sex (P = .320), age (P = .362), or race (P = .180).
Conclusions: This pooled analysis provides evidence that 12 weeks of treatment with duloxetine 60-120 mg/d effectively improves fibromyalgia symptoms and may offer benefits beyond pain relief.