Speaker: Dong-Ho Song, MD, PhD, Professor, Department of Psychiatry and The Institute of Behavioral Science, Yonsei University College of Medicine, and the Yongdong Severance Hospital, Seoul, Korea
Aripiprazole (Bristol-Myers Squibb), a stabilizer of the dopamine-responsive/dependent circuits related to the pathophysiology of tics, was effective in managing tic symptoms and was well tolerated in children and adolescents with tic disorder or Tourette syndrome.
In a study that examined the short-term tic-suppressing effect of the antipsychotic agent, 21 children and adolescents with these disorders were enrolled in an eight-week, open-label study. Sixteen patients with Tourette syndrome and five patients with chronic motor tic disorder received aripiprazole, given at an initial daily dose of 5 mg. This amount was increased every two weeks in 5- to 10-mg increments to an effective and tolerable dose.
Outcome measures included The Yale Global Tic Severity Scale, the Tic CGI-S Scale of 1 (normal) to 7 (extremely ill), and CGI-I Scale of 1 (very much improved) to 4 (no change). Side effects also were assessed after aripiprazole administration.
Overall, the aripiprazole dose during eight weeks was 17.5 ±7.3 mg/day. Significant reductions in the Yale Tic scores and CGI-S scores were noted between pretreatment and at post-treatment at the eighth week. Changes in CGI-I scores at the eighth week after treatment included “very much improved” in two patients (10%), “much improved” in nine patients (43%), minimally improved in six patients (28%), and “no change” in four patients (19%).
Possible drug-related adverse events included sleep problems (insomnia in one patient and hypersomnia in five patients), dizziness in two patients, and headache in one patient. No extrapyramidal symptoms, agitation, sedation, or weight gain was observed.
Topiramate Helpful for Patients with Binge-Eating Disorder
Speaker: Ema Saito, MD, Psychiatrist and Research Scientist, Zucker Hillside Hospital, Glen Oaks, New York
Results from a 16-week pilot study indicated that topiramate (Topamax generic, Ortho-McNeil), a well-known anticonvulsant that has shown efficacy in reducing the frequency of binge-eating in short-term studies, proved effective in decreasing the frequency of episodes in adolescents and young adults with binge-eating disorders.
A 16-week, open-label study enrolled 12 individuals (mean age, 17.75 years), seven with bulimia nervosa and five with binge-eating disorder. The subjects received a flexible dose of canadian topiramate, ranging from 25 to 400 mg. The dose was titrated by 25 mg to 50 mg weekly according to the clinical response, as assessed by binge-eating diaries and patients’ tolerability. If binge-eating behavior decreased by 50%, compared with the previous week, the dose of topiramate was to remain the same.
Follow-up was performed weekly for 10 weeks. If patients were stable after week 10, they were seen every two weeks. The patients were allowed to continue co-medication and psychotherapy throughout the study period. Six patients received additional medication for comorbidities or both.
The researchers conducted an assessment of adverse effects at the baseline evaluation, at the 10th week, and at the study’s endpoint. Laboratory evaluations were also performed at these three time points. The following instruments were used:
- the Hillside Adverse Events Form
- the Binge-Eating Scale (BES)
- cognitive function tests: Boston Naming Tests (BNT), Trail-Making Tests A & B (TMT-A&B), and the Barrett Impulsive Scale, version II (BIS-II)
Seven patients completed the 16-week study, and two others completed at least 10 weeks of study participation. Three patients dropped out.
The time (P < .007) and topiramate dose (mean dose, 112.5 mg/day) (P < .02) were significant factors in bringing about a decrease in the frequency of binge-eating, from 5.3 episodes per week to one episode per week.
Barrett Scale-II and Trail-Making Test-B scores did not show any significant differences between the two time points.
The change in weight was not significant between the two time points: 154.1 pounds at beginning of the study to 152.5 pounds at the endpoint. Improvements in the Boston Naming Test between the two time points, however, were significant (P < .0014)—from a score of 52.9 to 56. The normal score was 56.1.
Trail-Making Test-A scores also improved.
Paroxetine May Increase Risk of Suicidal Behavior in Young Adults
Speaker: David J. Carpenter, MS, PharmD, Senior Director of Psychiatry, Neurosciences Medicine Development Center, GlaxoSmithKline, King of Prussia, Pennsylvania
Data from all GlaxoSmithKline placebo-controlled, paroxe-tine clinical trials enrolling young adults with major depressive disorders (MDD), along with other psychiatric disorders, suggest that this population might be at a significantly increased risk of suicidal behavior or ideation, compared with subjects receiving placebo.
The data were pooled from 62 studies of four to 12 weeks in duration. All of these studies involved 30 or more 18- to 24-year-old patients; 776 received paroxetine, and 542 received placebo. The investigators compared the incidence of definitive suicidal behavior or ideation (DSBI) and definitive suicidal behavior (DSB) in subjects receiving or placebo. Suicidal behavior encompassed a completed suicide, a suicide attempt, or a preparatory act relating to suicide.
Overall, a higher incidence of suicidal behavior, with or without ideation, was observed in those young adults receiving paroxetine than in those receiving placebo. In the DSBI group of patients, the incidence of suicidal behavior was 2.6% with paroxetine and 1.3% with placebo; in the DSB young adults, it was 2.2% with paroxetine tablet and 0.9% with placebo.
Similar patterns were observed in both depressive and non-depressive disorders. This possible increase in the risk of suicidal behavior in the paroxetine-treated patients was noted despite the efficacy of active drug therapy.