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Regulatory and Legal Briefs

Lamictal was approved June 23 by the FDA for the maintenance treatment of adults with bipolar I disorder. The drug delays the onset of mood episodes (depression, mania, hypomania, mixed episodes). Lamictal is only the second medication (lithium was the first) to be approved for the long-term maintenance of patients with bipolar disorder. While Lamictal delays the onset of mood episodes, it has not been found to be an effective treatment for ending an acute mood episode. Common adverse events include nausea, insomnia, somnolence, back pain, and rash. Complete prescribing information is available on the Web at www.lamictal.com.

Research Briefs

• Monitoring lithium levels is routine; however, new research indicates that the utility of lithium blood levels in women who are breast-feeding may not be a good estimate of how much of the medication may be passing to the infant. In a study from the Motherisk Program in Toronto, lithium levels present in breast milk were found to be widely variable, ranging from zero to 30 percent of the maternal dose.
Therapeutic Drug Monitoring2003; 25(3):364-366
Antipsychotic prescribing has been shown in the past to be subject to cultural and racial bias. A new analysis of data from January 1996 through August 1998 indicates the bias was still present. When other demographics were controlled for in a sample of 2,600 patients receiving medication through the Texas Medicaid system, African Americans were found to be significantly less likely to receive a newer, atypical medication, such as olanzapine, than haloperidol.
J Clin Psychiatry2003; 64:635-639
NSAIDs may not be of any benefit to patients with Alzheimer’s disease. Non-steroidal anti-inflammatory drugs have been linked in previous research to a slowing of the rate of decline of patients with mild to moderate Alzheimer’s. Laboratory data have also indicated that these drugs may decrease the formation of pathological amyloid plaques. However, in a report from the Alzheimer’s Disease Cooperative Study consortium, two NSAIDs, rofecoxib and naproxen, were found to have no significant effect on patients’ ADAS-Cog scale scores compared with placebo over one year.
JAMA2003; 289(21):2819-2826
• Long-term benzodiazepine use does not appear to lead to notable escalation in doses. A review of more than 2,400 patients in the New Jersey Medicaid system looked for patients who had received prescriptions for benzodiazepines indicating at least two years of continuous use. No clinically or statistically significant changes in dosage were observed over time. The overall incidence of escalation of dose was 1.6 percent. Those at higher risk of dose escalation were patients who also were prescribed antidepressants and those who filled duplicate prescriptions at multiple pharmacies over short periods of time. Elderly and disabled patients had lower risk of dose escalation than did younger patients.
Psychiatric Services2003;54:1006-1011
• Discontinuation of antidepressants in patients with bipolar disorder significantly increases patients’ risk of depressive relapse. A total of 84 patients who had achieved remission from a depressive episode with an antidepressant added to a mood stabilizer were followed for at least one year. One year after successful antidepressant response, 70 percent of the 43 patients who had stopped the antidepressant within the first six months had experienced a depressive relapse, compared with 36 percent of the 41 patients who had continued their antidepressant medication beyond six months. No apparent effect was seen in incidence of manic episodes between the two groups.
Am J Psychiatry2003; 160:1252-1262
Escitalopram appears to be effective and is well tolerated by patients with depression treated in the primary care setting. An eight-week, double-blind, placebo trial compared escitalopram with citalopram and placebo. Escitalopram was statistically significantly better than placebo, based on scores from the Montgomery-Asberg Depression Rating Scale. In addition, both medications were well tolerated, with adverse effect rates equivalent to those of placebo. Patients taking escitalopram had a significantly higher rate of response than those taking both placebo and citalopram.
Int Clin Psychopharmacology2003; 18(4):211-217
Sertraline may be more effective than fluoxetine for treatment of anxious depression. In an analysis of five double-blind comparator studies with a total of 650 patients, both drugs were found to have a comparable antidepressant effect in general in patients with major depression. However, when data were analyzed according to subgroups of patients with anxious depression compared with those with severe depression, sertraline was linked to significantly greater improvement on the Hamilton Depression Rating Scale in those with anxious depression.
Int Clin Psychopharmacology2003; 18(4):203-210
Sertraline appears to be effective and well tolerated in elderly patients with depression. In a study of more than 550 patients randomly assigned to receive either sertraline or placebo, the patients taking sertraline had significantly more improvement in their scores on the Hamilton Depression Rating Scale and the Clinical Global Impression severity and improvement subscores.
Am J Psychiatry2003; 160:1277-1285

Industry Briefs

• Forest Laboratories announced June 19 that a preliminary analysis of data showed that there was no significant difference between patients who had mild to moderate Alzheimer’s disease and were given memantine in combination with a cholinesterase inhibitor compared with patients who received placebo and the same cholinesterase inhibitor.
Previous research had shown both reductions in the rate of decline as well as improvement in scores on cognitive exams in patients with severe Alzheimer's disease taking memantine alone. Researchers had hoped that the combination of memantine, added to standard cholinesterase therapy would produce more improvement than memantine alone. ▪

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Published online: 1 August 2003
Published in print: August 1, 2003

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Jim Rosack, Compiled by

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