FDA Approves Milnacipran HCI for the Management of Fibromyalgia

The United States Food and Drug Administration approved milnacipran HCl (Savella, Forest Laboratories) for the treatment of fibromyalgia. It will be available in 12.5-mg, 25-mg, 50-mg, and 100-mg dosages.

The safety and efficacy of milnacipran HCI, a selective serotonin and norepinephrine dual reuptake inhibitor, was established in two clinical trials with a combined study population of 2,084 patients (1,460 milnacipran; 624 placebo). Both trials, with a 6- and 3-month duration for trials one and two, respectively, demonstrated clinically significant improvement compared to placebo. More milnacipran patients than placebo patients reported ≥30% reduction in pain (100 mg/day and 200 mg/day) in both studies by month 3.

Common adverse events included nausea, constipation, hot flush, hyperhidrosis, vomiting, palpitations, heart rate increased, dry mouth, and hypertension.

For complete safety, prescribing, and efficacy information, please visit www.frx.com. –LS

Psychological Distress Risk Increases for Siblings of Patients with Mental Health Disorders

Despite their prevalence, few studies have examined the effect of mental health disorders or intellectual deficits on the siblings of affected patients, siblings’ development during childhood, and the progression of any significant effect from that relationship into adulthood. Prior studies have shown that 5% of the adult population in the United States is affected by a serious mental health disorder, and >15% of the US adult population has intelligence testing scores that suggest mild to severe intellectual deficits. Research on siblings of patients with developmental disabilities have shown that the patient/sibling relationship is often quite different from a relationship between siblings without any disability. However, this finding has not been replicated for patients with mental illness or intellectual deficits.

Julie Lounds Taylor, PhD, of the University of Wisconsin–Madison, and colleagues studied 83 siblings of patients with mental health disorders and 268 siblings of patients with mild intellectual deficits to understand if such impairment affected the siblings’ development in childhood and into adulthood. They hypothesized that siblings of patients with mental illness would have relationships characterized by less closeness and contact, and would experience more distress than siblings of healthy controls. Siblings of patients with intellectual deficits were hypothesized to have similar levels of distress when compared to siblings of healthy controls, among other hypotheses.

Taylor and colleagues gathered patients from the Wisconsin Longitudinal Study, a sample of 10,317 people whose life course, including education, health, career, and family, have been evaluated since 1957. For study inclusion, patients with intellectual deficits had Henmon–Nelson Test of Mental Ability scores of ≤85. Patients with mental health disorders were determined via self-report responses. Of those who responded to being diagnosed with a mental health disorder, 85.5% were diagnosed with either a depressive and/or anxiety disorder. Patient siblings could not have IQ scores ≤100 or have been diagnosed in the past with a mental illness for study inclusion.

Patient/sibling relationship was measured using structured interviews, and sibling distress was measured using the Center for Epidemiological Studies–Depression Scale. The authors found that siblings of patients with mental health disorders had a 63% increased risk of having a depressive episode during their lifetime, when compared to 791 siblings of healthy controls. Siblings of patients with mental illness also reported more psychological distress, less psychological well-being, and less adaptive personality characteristics as compared to siblings of healthy controls.

Gender also contributed to the effect of patient mental illness on a sibling. Siblings of male patients with mental illness had significantly lower well-being scores than siblings of healthy controls. Siblings of patients with intellectual deficits showed reduced feelings of emotional closeness to patients, despite living in geographically nearer areas than siblings of patients without intellectual deficits. Neither sibling group showed differences in life course patterns (ie, marriage, childbirth) due to their relationship with patients.

Taylor and colleagues concluded that having a sibling with a mental health disorder or intellectual deficits does alter the sibling relationship, and can contribute to the development of psychological distress for the healthy sibling. The authors added that other social and environmental factors may also contribute to the development of depression and distress for siblings of patients with mental illness.

Funding for this research was provided by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute on Aging. (J Fam Psychol. 2008;22(6):905-914.) –CP

Sertraline and CBT: Combination Therapy in Pediatric Anxiety Disorders

Pediatric anxiety disorders are common (10% to 20% prevalence estimates) and can have detrimental effects on family, educational, and social functioning. These disorders are typically treated with cognitive-behavioral therapy (CBT) or selective serotonin reuptake inhibitors (SSRIs).

John T. Walkup, MD, at the Johns Hopkins Medical Institutions in Baltimore, Maryland, and colleagues conducted a multicenter, randomized controlled trial to assess the relative and combined efficacy of SSRIs and CBT for pediatric anxiety disorders. Participants included 488 children, 7–17 years of age. Primary diagnoses included separation anxiety disorder, generalized anxiety disorder, or social anxiety disorder, as verified by the Anxiety Disorders Interview Schedule for the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision, Child Version.

In the first of two phases of this study, Phase 1 represented a short-term, 12-week trial comparing CBT, sertraline, and sertraline/CBT combination with placebo. Phase 2 represented a 6-month open extension for Phase 1 treatment responders.

CBT included fourteen 60-minute sessions with progress and symptom reviews. Pharmacotherapy included eight 30–60-minute sessions, with sertraline and placebo starting at 25 mg/day and increasing up to 200 mg/day by week 8. Administration of sertraline monotherapy, CBT monotherapy, and placebo was double blind. Sertraline/CBT combination therapy was open label.

Patients who were very much or much improved, as defined by the Clinical Global Impression-Improvement scale, included 80.7% for combination therapy (P<.001), 59.7% for CBT (P<.001), 54.9% for sertraline (P<.001), and 23.7% for placebo. Combination therapy was superior to monotherapy, and all active treatment was superior to placebo. In addition, no adverse events were reported more frequently in the sertraline group than in the placebo group.

Funding for this research was provided by the National Institute of Mental Health; sertraline and placebo were provided by Pfizer. (N Engl J Med. 2008;359(26):2753-2766.) –LS


Psychiatric dispatches is written by Carlos Perkins, Jr. and Lonnie Stoltzfoos.