D ROP B Y B OOTH #585
FOR AN I P OD , PAGE
Clinical Psychiatry News
VO L . 3 4 , N O. 5 www.clinicalpsychia tr ynews.com T he Leading Inde p endent Ne wspaper for the Psychiatrist—Since 1973 M AY 2 0 0 6
New Patch for Kids May Broaden Use Of ADHD Therapy
Transdermal methylphenidate approved.
BY ROBERT FINN
©A MY S TONE
‘Grizzly Man’ shows director Werner Herzog’s enduring attraction to danger.
San Francisco Bureau
Dr. Eugenio M. Rothe, director of the University of Miami’s child and adolescent psychiatry clinic, has treated many refugees.
Twenty-week cognitivebehavioral program shows promise.
Trauma Takes Toll On Young Refugees
BY SHARON WORCESTER
M I A M I B E A C H — Posttraumatic stress disorder symptoms are emerging as a common and often unrecognized result of the immigration experience, Dr. Eugenio M. Rothe reported at the annual meeting of the American Society for Adolescent Psychiatry. In his work treating young refugees, he has found that many experience posttraumatic stress disorder (PTSD; see box, page 37.) For example, the refugees confined in the early 1990s to the camps at the U.S. Naval Station Guantanamo Bay, Cuba, had to endure the indignities of camp confinement, after being intercepted at sea and before eventually being admitted to the United States. During their sea journeys, they experienced trauma that often included witnessing death and corpses of family members being devoured by sharks. At one point, the camps contained 32,000 refugees in a 42square-mile area, where people lived in tents with up to 14 people, often strangers. The accumulation of traumatic events such as these takes its toll, said Dr. Rothe, director of the child and adolescent psychiatry clinic at the University of Miami. He described several studies focusing on PTSD in children and adolescents.
In a study of the first 301 refugees from these camps who were aged 3-19 years and who sought, or were referred for, psychiatric services, 84% of preschool-age girls and 91% of preschool-age boys scored in the “very severe” range on the Posttraumatic Stress Disorder Reaction Index. Most of the school-age and adolescent children (though fewer than in the preschool group) also scored in this range. A second study assessed cognitive-related PTSD symptoms in a subpopulation of refugees who first traveled to the Cayman See Refugees page 37
he Food and Drug Administration’s approval of a transdermal methylphenidate patch for the treatment of attention-deficit hyperactivity disorder in children could broaden use of the drug for patients who need it. “Some patients may have difficulty swallowing the tablets, and patients may prefer to use the patch,” Dr. Joseph Biederman, professor of psychiatry at Harvard Medical School, Boston, said in an interview. “So it’s a technology that may allow physicians to expand the repertoire of choices.” Dr. Thomas Laughren, direc-
tor of the FDA’s division of psychiatric products in Rockville, Md., agreed. During a meeting of the FDA’s Psychopharmacologic Drugs Advisory Panel in December, the agency heard from several advisers and others that a “substantial fraction” of children have difficulty taking pills, Dr. Laughren said during a media teleconference sponsored by the FDA. “They felt that this would be an important addition to the available treatments for ADHD.” Dr. Richard Gorman said in an interview that he also thinks that another dosage form will open use of the drug for patients who have had difficulty with methylphenidate in the past. See ADHD Patch page 38
Researchers are hot on the trail of selective nicotinic agonists.
CMS to Cut Physician Pay by 4.6% in 2007
B Y A L I C I A A U LT
Associate Editor, Practice Trends
Top 10 Diagnoses by Psychiatrists in 2005
Major depressive disorder, single episode Depressive disorder Anxiety states Bipolar I disorder Attention-deficit disorder Dysthymic disorder Major depressive disorder, recurrent episode Paranoid schizophrenia Other adjustment reactions Schizophrenia
4.8% 4.7% 3.3% 2.6% 2.5% 7.6% 6.5% 11.5% 10.8%
S ARAH L. G ALLANT /E LSEVIER G LOBAL M EDICAL N EWS
n a not unexpected but definitely unwelcome move, the Centers for Medicare and Medicaid Services has announced that it will cut physician pay by 4.6% for 2007. The federal health program said the scheduled decrease in physician fees is based partly on the fact that spending for physicians’ services rose by 8.5% in 2005, with 7.5% of that rise due to growth in the volume and intensity of physician services. But physician organizations
blame the hit on the sustainable growth rate (SGR). If Medicare spending on physicians increases more than the SGR, CMS must cut physician fees; lower spending means higher rates for physicians. But errors made in setting the SGR in 1998 and 1999 have led to annual proposed cutbacks and yearly congressional bailouts. Last year, for instance, medical organizations successfully lobbied Congress to block a proposed 4.4% cut for 2006, but because legislators did not increase fees, payments essentially were frozen at the 2005 rate. See CMS page 78
Note: Based on projected nationwide data from a monthly survey of about 162 psychiatrists. Source: Verispan
C L I N I C A L P S YC H I AT RY N E W S • M ay 2 0 0 6
Use May Widen
for an extended period of time indicated that sensitization could be a possibility. At the panel meeting, Shire cited two ADHD Patch from page 1 studies of children aged 6-12 years with “Whether it will be widely accepted or not ADHD—a 2-day laboratory classroom study I think is still an open question,” said Dr. of 93 children and a pivotal multicenter Gorman, chairman of the section of clini- outpatient study of 274 children that comcal pharmacology and therapeutics for the pared the patch with oral methylphenidate (Concerta) and placebo over 7 weeks. SigAmerican Academy of Pediatrics. It is important to note that use of a patch nificant improvements in behavior were by young children would require interven- seen within 2 hours of application of the tion by a responsible adult at specific times patch (left on for 9 hours) and persisted for twice a day, compared with just once a day 3 hours after removal, the company said. The label instructions call for the patch to for oral forms of methylphenidate, said Dr. Gorman, a pediatrician in private practice in left on for a maximum of 9 hours, but Dr. Baltimore. The approval applies to children Biederman said that it can be left on for longer than 9 hours for a longer duration of aged 6-11 years. Approval of the patch—which is called effect. “We know from the early studies that Daytrana and was codeveloped by Shire the patch continues to work for about 2 hours after it’s rePharmaceuticals Inc. moved,” he said. “So it and Noven PharmaThe patch will continue to may permit clinicians ceuticals Inc.—had work for about 2 hours and families to actualbeen widely expected ly vary the duration of after the panel’s enafter being removed, ‘so it effect, depending on dorsement. But the may permit clinicians and the individual needs of panel, citing the the particular day, patch’s potential to families to actually vary week, or month.” cause sensitization to the duration of effect.’ Normally, the patch m e t hy l p h e n i d a t e , is to be applied to alquestioned how strong ternating areas of the child’s thighs each the warnings on the label would be. Sensitization can occur with any medica- morning and removed later that day. But in tion delivered using a transdermal patch. the provocation study, patches were applied People sometimes develop antibodies to to a single area and left on continuously for the medication in transdermal patches, and days at a time, and 13% of patients did dewhen they are later challenged with an oral velop sensitivity. For that reason, the label of the product version of the medication, they may experience an allergic reaction. Theoretically, as it will be released contains advice for this could prevent a child who had used the physicians on how to recognize and manage methylphenidate patch from ever taking an sensitization. Redness at the patch site is very common and does not by itself indioral form of the medication. Dr. Laughren said such a sensitization re- cate sensitization. But if there is something action had never been seen in 765 patients beyond redness—such as edema, papules, or exposed to methylphenidate patches in short- vesicles—a dermatologist would need to exterm trials. In one case that had been thought amine that child to determine whether sento involve sensitization, further study showed sitization had actually occurred. The patch will be available in four dosages: that sensitization did not occur. However, a separate provocation study with treatment 10 mg, 15 mg, 20 mg, and 30 mg. s
Study Reinterpreted: OCD Responds to Skilled Therapy
B Y J E F F E VA N S
N E W Y O R K — Cognitive-behavioral therapy, when provided by a skilled therapist, can be just as effective as an SSRI or combined treatment for children with obsessive-compulsive disorder, Dr. Daniel S. Pine said at a psychopharmacology update sponsored by the American Academy of Child and Adolescent Psychiatry. To reach that conclusion, Dr. Pine interpreted data from the Pediatric OCD Treatment Study differently than did the study’s investigators. The Pediatric OCD Treatment Study is the only published trial that compares cognitive-behavioral therapy (CBT) with an SSRI for the treatment of pediatric OCD, said Dr. Pine, chief of the section on development and affective neuroscience in the mood and anxiety disorders program at the National Institute of Mental Health. In the study, 112 patients were randomized to receive sertraline (Zoloft), cognitive-behavioral therapy (CBT), a combination of the two modalities, or placebo for 12 weeks. Patients were treated at one of three sites, and were enrolled primarily at two of the sites ( JAMA 2004;292:1969-76). “There were robust site differences in the response to treatment,” he said. “When you look very carefully at the data that are published, what you see was that one site had a massive response to CBT and there was no benefit of adding an SSRI to CBT.” The other site had a “very weak” response to CBT, an “okay” response to an SSRI,
and a “robust” response to the combination treatment, he noted. The averaged data for the three sites showed a statistically significant benefit of combination therapy over CBT alone, sertraline alone, and placebo. The investigators concluded that pediatric patients with OCD should receive combination therapy. “Personally, I think that’s a misreading of the study,” Dr. Pine said. “I think what the study really tells us is that really well-executed CBT in kids with OCD is every bit as good as monotherapy [with an SSRI] and is every bit as good as combination therapy; however, not-so-great CBT really needs an SSRI to work.” “It would be wonderful if CBT was always the same across therapists, patients, and cities, but it’s not, and this study really shows it,” he added. CBT might be the preferred method for treating pediatric OCD, especially in patients without a history of attentiondeficit hyperactivity disorder or major depression, because the availability of a CBT therapist will vary depending on geographic location and the fact that there are “tremendous site differences in CBT,” he said. “This recommendation only applies to the case where you have access to a very skilled CBT therapist who has worked with pediatric anxiety disorders,” Dr. Pine explained. An SSRI should be used if a skilled CBT therapist is not available or if a child has a severe anxiety disorder and will not undergo the crucial part of CBT that involves exposure to the feared stimulus, he advised. s
L I N I C A L
A P S U L E S
Borderline Traits Tracked in Teens Borderline personality disorder appears to encompass a much broader range of psychopathology in adolescent inpatients than in hospitalized adults, reported Dr. Daniel F. Becker of the University of California, San Francisco, and his colleagues. The investigators interviewed 123 adolescent inpatients, aged 13-18 years, who were a mean age of 15.9 years. Most (104) were white; 67 (54%) were boys (Compr. Psychiatry 2006;47:99-105). Based on interviews, borderline personality disorder (BPD) was diagnosed in 65 adolescents—45% of boys and 65% of girls—and four factors associated with BPD presentation accounted for 67% of the overall variance. Factor 1 reflected negative or self-deprecating aspects of BPD presentation, such as suicidal threats and gestures, and feelings of emptiness or boredom. Factor 2 covered affective dysregulation or irritability, including uncontrolled anger. Factor 3 reflected interpersonal problems, such as unstable relationships. Factor 4 reflected impulsiveness. These factors suggest that BPD in teens may be associated with Axis I disorders, and
more research is needed on the heterogeneity of BPD, the investigators noted. The existence of the four BPD factors that appear to differ from those reported for similar studies in adults raises “the question whether BPD is different in its nature and underlying structure in adolescents,” the authors wrote. Methylphenidate and Cell Abnormalities Methylphenidate is associated with significant increases in cell abnormalities when given to children at therapeutic levels, reported Dr. Randa A. El-Zein of the University of Texas M. D. Anderson Cancer Center, Houston, and colleagues. Data from 12 children showed significant increases in several genotoxic end points after 3 months of daily treatment with methylphenidate. The children, whose average age was 9 years, received doses ranging from 20 mg/day to 54 mg/day (Cancer Letters 2005;230:284-91). Peripheral blood lymphocyte samples were collected from the children at baseline and after 3 months of treatment and evaluated for cell abnormalities. Compared with baseline values, the children demonstrated a threefold in-
crease in the mean number of chromosomal abnormalities, from 1.7 per 50 cells to 5.1 per 50 cells. They also showed a 4.3fold increase in the mean number of sister chromatid exchanges (the number of crossover events in a chromosome pair), from 6.1 to 26.3, and a 2.4-fold increase in micronuclei frequencies per 1,000 cells, from 3.6 to 8.5. Despite the small sample size, the investigators said, their study was “remarkable in the consistency of the increase of every type of cytogenetic end point monitored, in every child receiving the drug.” The study opens the door for further larger studies that address these issues in order to establish the safety of methylphenidate, as well as possible replacement drugs, for treating ADHD, they said. Psychosocial Support, Pregnant Teens Pregnant adolescents who receive interdisciplinary prenatal and postpartum care and psychosocial support have lower rates of rapid pregnancy recurrence, Amanda Melhado reported at the annual meeting of the Society for Adolescent Medicine. In a prospective study of a “global care” model, Ms. Melhado, Dr. Maria José Carvalho Sant’Anna, and Dr. Verônica Coates
of Faculdade de Ciências Médicas da Santa Casa in São Paolo, Brazil, compared the outcomes of 30 adolescents who received specialized prenatal medical care and psychoeducational support with those of 39 age-matched adolescents who received standard prenatal care only. All of the young women in the study were 18 years old or younger at the time of conception and gave birth in the maternity ward of the same hospital between July 1, 2004, and June 30, 2005. No significant differences were found between the two groups with respect to marital status or relationship with the babies’ fathers, Ms. Melhado said. More than half of the young women in both groups were not married at the time of the study. The psychoeducational support component included group and individual sessions with a team of providers—including mental health professionals, obstetricians, and pediatricians—focusing on such topics as self-esteem, contraception, relationships, and infant development. As of March 2006, the rate of pregnancy recurrence among the young women who received the intervention was 3%, compared with 15% in the standard care group.
—Heidi Splete with staff reports