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Med Check
Psychiatric News
Volume 38 Number 12 page 19-19
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Atomoxetine appears to be effective in treating symptoms of emotional dysregulation, such as an inappropriately quick temper, affective lability, and emotional over-reactivity, often seen in adults with ADHD, according to Fred Reimherr, M.D., of the University of Utah School of Medicine and colleagues. In two concurrent multicenter studies involving a total of 451 patients, 31 percent experienced emotional dysregulation, as measured by the Connors’ Adult ADHD Rating Scale and the Wender-Reimherr Adult Attention-Deficit Disorder Scale. Atomoxetine significantly improved symptoms of emotional dysregulation with a treatment effect similar to improvements demonstrated in signs of hyperactivity/impulsivity and inattention. (Funded by Lilly Research Laboratories)

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• Patients with bipolar disorder who are prescribed antidepressants often are "switched" into mania. Ayal Schaffer, M.D., of the University of Toronto and colleagues reported that this may not be true for elderly patients with bipolar disorder. In a retrospective study, 1,072 elderly patients with bipolar disorder who were prescribed antidepressants were compared with 3,000 elderly patients with bipolar disorder who received no antidepressant medications. Over an average of 440 days of follow-up, patients who received antidepressant medications were half as likely to be admitted to a hospital for an acute manic episode as those not taking antidepressants. In addition, those taking antidepressants were 30 percent less likely to be admitted for depression. Shaffer believes that elderly patients may be "less biologically vulnerable to the switch" induced in younger patients who take antidepressants. (No industry funding)

Valproate may have no significant effect on total serum triglycerides, cholesterol, LDL, HDL, and fasting glucose levels, in contrast to some atypical antipsychotics used to treat acute mania that have been associated with significant elevations of lipids and serum glucose levels. In a small retrospective chart review, Susan Leckland, R.Ph., of the University of California, San Diego, and colleagues found that of 935 records examined, only 37 were found to have adequate data on total cholesterol, and not all of those 37 had complete data on the other metabolic factors. However, even though those 37 patients were noted to have gained significant weight resulting in increased body mass index (BMI), no significant changes were found in the data available on any of the metabolic laboratory values. The researchers noted that the significant lack of appropriate data on metabolic factors in the 935 patients indicates that certain aspects of routine medical care, for example, routine monitoring of serum lipids and glucose, are largely lacking in psychiatric settings. (Funded by Abbott Laboratories)

• Extended-release carbamazepine is effective as a maintenance medication for patients with manic or mixed bipolar disorder, reported Mark Hamner, M.D., of the Medical University of South Carolina and colleagues. In a six-month, open-label extension trial, 77 patients who had previously received either carbamazepine or placebo in a three-week, double-blind trial were given extended-release carbamazepine for an additional six months. Patients who had previously received placebo significantly improved as measured by Young Mania Rating Scale and Clinical Global Impressions scale scores. Improvements seen in the first three weeks for patients taking carbamazepine were maintained with the extended-release formulation through the six-month trial. Adverse events were mild to moderate, including headache, dizziness, and rash, all typical of carbamazepine. No cases of significant weight gain, serious rash, aplastic anemia, or agranulocytosis were noted. (Funded by Shire Pharmaceutical Development)

Oxcarbazepine may be effective for the treatment of patients with refractory bipolar disorder, reported Dennis Platt, M.D., of Tallahassee (Fla.) Memorial Hospital and colleagues. The study consisted of a retrospective chart review of 146 patients with bipolar disorder who had either failed or were unable to tolerate previous mood stabilizers and antidepressants. Oxcarbazepine, either as monotherapy or an adjunct to other psychotropic medications, was associated with significant reductions in the patients’ scores on depression and mania rating scales. Fourteen percent of patients discontinued oxcarbazepine due to lack of efficacy, and an additional 14 percent discontinued due to adverse events, including nausea, rash, and dizziness. (Funded by Novartis Pharmaceuticals)

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Escitalopram is safe and effective for treatment of severe depression, reported Phillip Ninan, M.D., of Emory University and colleagues. In a prospective, double-blind placebo trial, 300 patients with severe depression (a mean baseline score of greater than 30 on the 24-item Hamilton Depression Rating Scale) received either 10 mg to 20 mg of escitalopram or placebo for eight weeks. Escitalopram was statistically significantly superior to placebo in reducing patients’ depression ratings on the Hamilton and the Montgomery Asberg Depression Rating Scale, as well as on the Clinical Global Impression scales by week 2 of the trial. The statistical difference between escitalopram and placebo was maintained throughout the trial. Approximately 50 percent of patients taking escitalopram experienced a 50 percent or greater reduction in their depression scores, compared with only 30 percent of those taking placebo. (Funded by Forest Laboratories and Integrated Therapeutics)

Duloxetine appears to be associated with less sexual dysfunction than paroxetine, reported Stephen Brannan, M.D., of Lilly and colleagues. In a retrospective analysis of pooled data from four clinical trials, the incidence of sexual dysfunction with duloxetine was significantly lower than with paroxetine in acute-phase trials. In long-term studies the incidence of sexual dysfunction in patients on duloxetine fell between that of placebo and paroxetine. The study utilized the Arizona Sexual Experience Scale, a five-item questionnaire that assesses functioning in a number of areas. Acute data were collected during four eight-week, placebo-controlled, double-blind trials, and long-term data were collected during a 26-week extension phase of two of those acute trials. Duloxetine is a serotonin-norepinephrine reuptake inhibitor. The most common adverse events noted during clinical trials were nausea, dry mouth, constipation, decreased appetite, fatigue, somnolence, and increased sweating. (Funded by Lilly Research Laboratories)

Tamoxifen, a synthetic, nonsteroidal estrogen antagonist used in patients with estrogen-mediated breast cancer, does not appear to increase a patient’s risk of developing depression during treatment for the disease, reported Kelly Lee, Pharm.D., of the University of California at San Francisco and colleagues. Clinical observations had suggested that tamoxifen was associated with an increased risk of depression. In a retrospective cohort study, nearly 3,000 patient records were reviewed to determine whether depression was present at the start of tamoxifen treatment or developed during treatment. A hazard ratio was calculated for tamoxifen and the risk of developing depression due to the medication, and was found to be 1.052. (Funded by Kaiser Permanente Division of Research)

Risperidone is a cost-effective adjunct medication in the treatment of Medicaid patients with depression, according to Dennis Meletiche, Pharm.D., of Janssen Pharmaceutica. In an analysis of Medi-Cal (the California Medicaid system) patients with one or more medical claims for depression, augmentation with risperidone or olanzapine was tracked, and utilization of health services and costs were examined. Duration of treatment with either atypical antipsychotic was similar (92.1 days for risperidone vs. 88.4 days for olanzapine), but costs of the medications differed significantly, with risperidone averaging a total cost of $493 vs. $806 for olanzapine. Nearly 63 percent of patients taking risperidone had total mental health costs below the median, while 60.8 percent of patients taking olanzapine had costs above the median. Total utilization of mental health services did not significantly differ between the two groups; however, service utilization prior to initiation of the atypical antipsychotic medication strongly predicted utilization patterns after beginning the medication. (Funded by Janssen Pharmaceutica)

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Aripiprazole is associated with less weight gain and lower risk of elevation of cholesterol and triglyceride levels compared with olanzapine, reported Robert McQuade, Ph.D., of Bristol-Myers Squibb. In a double-blind, multicenter study, 317 patients were randomly assigned to take either aripiprazole or olanzapine and followed for 26 weeks. Efficacy of the two medications was comparable when measured by changes in the Positive and Negative Syndrome Scale (PANSS) total score and scores on the Clinical Global Impression-Improvement scale across the 26-week study. More olanzapine patients experienced a greater than 7 percent increase in weight than patients treated with aripiprazole. Patients on aripiprazole on average lost three pounds, while patients on olanzapine gained more than nine pounds on average. A significantly greater number of olanzapine-treated patients who had normal baseline values for cholesterol and triglycerides experienced elevations in those values compared with patients taking aripiprazole, whose values remained stable. (Funded by Bristol-Myers Squibb)

Ziprasidone is as effective but better tolerated than risperidone, according to Donald Addington, M.D., of the University of Calgary in Alberta, Canada. In a double-blind, 52-week head-to-head trial with more than 250 hospitalized patients, ziprasidone and risperidone were found to be equally effective in patients with schizophrenia or schizoaffective disorder. However, patients on ziprasidone had a lower risk of developing a movement disorder, gaining weight, and experiencing elevated prolactin levels. (Funded by Pfizer Inc.)

Long-acting risperidone is safe and effective in the maintenance treatment of patients with schizophrenia, data from two studies indicate. In the first study, Martin Turner, M.D., of the Larkfield Centre in Glasgow, Scotland, reported that patients who were stable on conventional depot antipsychotics showed significant reductions in movement disorders and symptoms when switched to long-acting risperidone. In the second study, Stephen Rodriguez, M.S., of Janssen Pharmaceutica reported that long-acting risperidone, when given every two weeks, is effective in both hospital inpatients and outpatients. Severity of movement disorders was mild, and patients experienced little or no pain or discomfort at the injection site. Adverse events noted were consistent with those experienced with oral risperidone. (Funded by Janssen Pharmaceutica) ▪

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