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Deep Brain Stimulation & Treatment-Resistant Depression

About 1% to 3% of the United States population has treatment-resistant depression (TRD), a costly and disabling disorder. In recent clinical trials, deep brain stimulation (DBS) has been used on various neuroanatomic targets in the brain in an effort to treat TRD. Helen S. Mayberg, MD, and colleagues in Toronto published a report in 2005 which demonstrated encouraging results when using DBS in the subcallosal cingulate (SCC) matter, an area of the brain that has been dubbed “Area 25.” In this study, patients with TRD who had DBS experienced antidepressant response rates in excess of 50% when assessed 6 and 12 months after the procedure. “Although results were encour­aging, this initial pilot study was limited by being an open-label investigation,” says Dr. Mayberg. In an effort to garner more long-term efficacy and safety data on SCC DBS for TRD and extend experience with the procedure, Dr. Mayberg teamed up with Paul E. Holtzheimer, MD, and colleagues at Emory University and published a study in the February 2012 Archives of General Psychiatry involving 17 TRD patients who received the procedure. The analysis also aimed to address whether there was an antidepressant effect associated with sham SCC DBS and if the procedure was safe and effective in patients with treatment-resistant bipolar depression. (see also, Navigating Patients Through Depression) Analyzing the New Data on DBS In the study by Drs. Holtzheimer and Mayberg, participants received single-blind sham SCC DBS for 4 weeks, in which patients did not know if the DBS system was on or off. This was followed by active stimulation for 24 weeks. Patients were evaluated for up to 2...

Racial & Ethnic Disparities in CAD

Previous research has shown that there appears to be disparate care among different racial and ethnic populations, especially in the treatment of coronary artery disease (CAD). Clinical studies also suggest that there are differences in the use of evidence-based medicine among these different racial and ethnic groups. According to published data, minorities with acute coronary syndromes are more likely to receive sub-standard care. It has been shown throughout the medical literature that racial and ethnic minorities often receive evidence-based treatments less frequently than Caucasians. Other studies show that minorities are often treated at facilities that are not as adept at adhering to composite performance measures. The Get With the Guidelines-CAD (GWTG-CAD) quality improvement program, provided by the American Heart Association and American Stroke Association, is designed to enhance hospital adherence to guidelines when managing CAD patients. The program employs a set of performance, quality, and reporting measures to track the quality of care at an institution, and it has been proven to improve adherence to evidence-based care of patients hospitalized with CAD. A part of the GWTG-CAD program is directed toward improving ethnic and racial disparities among CAD patients to the point where care is defect-free. The concept of defect-free care is a critical component in the GWTG-CAD program. At its core, defect-free care is intended to ensure that every patient receives all of the interventions for which they’re eligible. These interventions are also known as performance measures because their use in CAD patients is supported by well-grounded scientific evidence. Therefore, performance measures are well-suited for public reporting to compare hospitals and pay-for-performance initiatives. Quality Improvement Programs Work In...

A Guideline Update for Major Depressive Disorder

The impact of major depressive disorder (MDD) on patients and their families is substantial. MDD adversely affects the patient as well as others, with the most serious complication of a major depressive episode being suicide. The disorder has also been associated with significant medical comorbidity. It can complicate recovery from other medical illnesses. Furthermore, MDD affects patients’ marital, parental, social, and vocational functioning. The disorder is unremitting in about 15% of patients and recurrent in another 35%. Compounding the problem is that treatment is often delayed. These factors highlight the need for changes in the delivery of mental health services to enhance timeliness and quality of care in MDD. With treatment, however, the prognosis associated with MDD is generally good. Most patients will respond to acute treatment, and continuation and maintenance therapy with acutely active treatments has been shown to lower the risk and severity of relapses into depression. Revisiting Previous Guidelines In 2010, the American Psychiatric Association (APA) released a new clinical practice guideline for the treatment of patients with MDD. This document (available online at www.psych.org/guidelines/mdd2010), the third since guidelines were originally created by the APA for MDD, revises a previous version that was published about a decade ago. “It includes new evidence-based recommendations on the use of antidepressant medications, depression-focused psychotherapies, and somatic treatments, such as electroconvulsive therapy,” says Alan J. Gelenberg, MD, who chaired the workgroup that developed the recommendations. “The guideline also addresses other topics, such as alternative and complementary treatments, treating depression during pregnancy, and strategies for treatment-resistant depression.” It took approximately 5 years to update the APA guidelines, Dr. Gelenberg says. “The update...

Emerging Drug Options: Adolescent Depression

Approximately 2 million adolescents between the ages 12 and 17 in the United States have suffered a serious bout of depression within the past year. Major depressive disorder (MDD) in adolescents is debilitating; about half of these patients will have continued problems with depression as they enter adulthood. Compounding the problem is the fact that few treatment options have been effective and well-tolerated in this patient group. In March 2009, the FDA approved a supplemental New Drug Application for escitalopram (Lexapro, Forest Laboratories, Inc.) as acute and maintenance treatment for MDD in adolescents aged 12 to 17. The SSRI is only the second antidepressant to be approved for the treatment of MDD in adolescents, the first of which was fluoxetine (Prozac, Eli Lilly and Co.). Encouraging Data After observing improvements in adults with MDD taking escitalopram, investigators more recently undertook several studies to assess efficacy in adolescents with MDD. The FDA’s most recent approval for use in adolescent depression was supported by two placebo-controlled studies, one conducted in adolescents taking the drug and the other conducted in children and adolescents taking citalopram (Celexa, Forest Laboratories, Inc.). In an 8-week flexible-dose, placebo-controlled study that compared escitalopram 10 mg/day or 20 mg/day to placebo in adolescents in 2008, those receiving escitalopram had statistically significant greater improvements from baseline when compared with placebo, based on the Children’s Depression Rating Scale-Revised (CDRS-R). In another 8-week, flexible-dose, placebo-controlled study, children and adolescents aged 7 to 17 treated with racemic citalopram 20 mg/day or 40 mg/day had statistically significant greater improvements from baseline on the CDRS-R when compared with patients treated with placebo. Positive results...
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