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VO L . 3 4 , N O. 5
Clinical Psychiatry News www.clinicalpsychia tr
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.
Reel Life BY ROBERT FINN tor of the FDA’s division of psy-
‘Grizzly Man’ shows director San Francisco Bureau chiatric products in Rockville,
Werner Herzog’s enduring Md., agreed. During a meeting of

attraction to danger. he Food and Drug Ad- the FDA’s Psychopharmacologic
ministration’s approval of Drugs Advisory Panel in De-
a transdermal methyl- cember, the agency heard from
Dr. Eugenio M. Rothe, director of the University of Miami’s child phenidate patch for the treat- several advisers and others that a
and adolescent psychiatry clinic, has treated many refugees. Borderline ment of attention-deficit hyper-
activity disorder in children
“substantial fraction” of children
have difficulty taking pills, Dr.
Personality could broaden use of the drug Laughren said during a media

Trauma Takes Toll Twenty-week cognitive-

behavioral program shows
for patients who need it.
“Some patients may have diffi-
culty swallowing the tablets, and
teleconference sponsored by the
FDA. “They felt that this would
be an important addition to the
patients may prefer to use the available treatments for ADHD.”
On Young Refugees PAGE 36 patch,” Dr. Joseph Biederman,
professor of psychiatry at Har-
Dr. Richard Gorman said in an
interview that he also thinks that
vard Medical School, Boston, said another dosage form will open
BY SHARON WORCESTER In a study of the first 301 in an interview. “So it’s a technol- use of the drug for patients who
Southeast Bureau refugees from these camps who ogy that may allow physicians to have had difficulty with
were aged 3-19 years and who expand the repertoire of choices.” methylphenidate in the past.
M I A M I B E A C H — Posttrau- sought, or were referred for, psy- Dr. Thomas Laughren, direc- See ADHD Patch page 38
matic stress disorder symptoms chiatric services, 84% of
are emerging as a common and preschool-age girls and 91% of
often unrecognized result of the
immigration experience, Dr. Eu-
preschool-age boys scored in the
“very severe” range on the Post- CMS to Cut Physician
genio M. Rothe reported at the traumatic Stress Disorder Reac-
annual meeting of the American
Society for Adolescent Psychiatry.
tion Index. Most of the school-age
and adolescent children (though
Alzheimer’s Pay by 4.6% in 2007
In his work treating young fewer than in the preschool Disease B Y A L I C I A A U LT blame the hit on the sustainable
refugees, he has found that many group) also scored in this range. Researchers are hot on Associate Editor, Practice Trends growth rate (SGR). If Medicare
experience posttraumatic stress A second study assessed cog- the trail of selective spending on physicians increases
disorder (PTSD; see box, page 37.)
For example, the refugees con-
fined in the early 1990s to the
nitive-related PTSD symptoms
in a subpopulation of refugees
who first traveled to the Cayman
nicotinic agonists.
I n a not unexpected but defi-
nitely unwelcome move, the
Centers for Medicare and Medic-
more than the SGR, CMS must
cut physician fees; lower spend-
ing means higher rates for physi-
camps at the U.S. Naval Station See Refugees page 37 aid Services has announced that cians. But errors made in setting
Guantanamo Bay, Cuba, had to it will cut physician pay by 4.6% the SGR in 1998 and 1999 have
endure the indignities of camp VITAL SIGNS for 2007. led to annual proposed cutbacks
confinement, after being inter- The federal health program and yearly congressional bailouts.
cepted at sea and before eventu- Top 10 Diagnoses by Psychiatrists in 2005 said the scheduled decrease in Last year, for instance, medical
ally being admitted to the United physician fees is based partly on organizations successfully lob-
States. During their sea journeys, Major depressive disorder, 11.5% the fact that spending for physi- bied Congress to block a pro-
single episode
they experienced trauma that of- 10.8% cians’ services rose by 8.5% in posed 4.4% cut for 2006, but be-
Depressive disorder
ten included witnessing death 2005, with 7.5% of that rise due cause legislators did not increase
Anxiety states 10.6%
and corpses of family members to growth in the volume and in- fees, payments essentially were

being devoured by sharks. Bipolar I disorder 7.6% tensity of physician services. frozen at the 2005 rate.
At one point, the camps con- Attention-deficit disorder 6.5% But physician organizations See CMS page 78
tained 32,000 refugees in a 42- Dysthymic disorder 4.8%
square-mile area, where people
Major depressive disorder, 4.7%
lived in tents with up to 14 people, recurrent episode
often strangers. The accumula- Paranoid schizophrenia 3.3%
tion of traumatic events such as 2.6%
Other adjustment reactions
these takes its toll, said Dr. Rothe,
director of the child and adoles- Schizophrenia 2.5%
cent psychiatry clinic at the Uni- Note: Based on projected nationwide data from a monthly survey of
versity of Miami. He described about 162 psychiatrists.
several studies focusing on PTSD Source: Verispan
in children and adolescents.
38 Child/Adolescent Psychiatry 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. Study Reinterpreted: OCD
ADHD Patch from page 1 At the panel meeting, Shire cited two
studies of children aged 6-12 years with
“Whether it will be widely accepted or not ADHD—a 2-day laboratory classroom study
Responds to Skilled Therapy
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 com- B Y J E F F E VA N S and a “robust” response to the combi-
cal pharmacology and therapeutics for the pared the patch with oral methylphenidate Senior Writer nation treatment, he noted.
American Academy of Pediatrics. (Concerta) and placebo over 7 weeks. Sig- The averaged data for the three sites
It is important to note that use of a patch nificant improvements in behavior were N E W Y O R K — Cognitive-behavioral showed a statistically significant bene-
by young children would require interven- seen within 2 hours of application of the therapy, when provided by a skilled fit of combination therapy over CBT
tion by a responsible adult at specific times patch (left on for 9 hours) and persisted for therapist, can be just as effective as an alone, sertraline alone, and placebo.
twice a day, compared with just once a day 3 hours after removal, the company said. SSRI or combined treatment for chil- The investigators concluded that pedi-
for oral forms of methylphenidate, said Dr. The label instructions call for the patch to dren with obsessive-compulsive disor- atric patients with OCD should receive
Gorman, a pediatrician in private practice in left on for a maximum of 9 hours, but Dr. der, Dr. Daniel S. Pine said at a psy- combination therapy.
Baltimore. The approval applies to children Biederman said that it can be left on for chopharmacology update sponsored “Personally, I think that’s a misread-
aged 6-11 years. longer than 9 hours for a longer duration of by the American Academy of Child and ing of the study,” Dr. Pine said. “I think
Approval of the patch—which is called effect. “We know from the early studies that Adolescent Psychiatry. what the study really tells us is that re-
Daytrana and was codeveloped by Shire the patch continues to work for about 2 To reach that conclusion, Dr. Pine in- ally well-executed CBT in kids with
Pharmaceuticals Inc. hours after it’s re- terpreted data from the Pediatric OCD OCD is every bit as good as monother-
and Noven Pharma- The patch will continue to moved,” he said. “So it Treatment Study differently than did apy [with an SSRI] and is every bit as
ceuticals Inc.—had may permit clinicians the study’s investigators. good as combination therapy; howev-
been widely expected work for about 2 hours and families to actual- The Pediatric OCD Treatment Study er, not-so-great CBT really needs an
after the panel’s en- after being removed, ‘so it ly vary the duration of is the only published trial that compares SSRI to work.”
dorsement. But the effect, depending on cognitive-behavioral therapy (CBT) “It would be wonderful if CBT was
panel, citing the may permit clinicians and the individual needs of with an SSRI for the treatment of pe- always the same across therapists, pa-
patch’s potential to families to actually vary the particular day, diatric OCD, said Dr. Pine, chief of the tients, and cities, but it’s not, and this
cause sensitization to week, or month.” section on development and affective study really shows it,” he added.
m e t hy l p h e n i d a t e , the duration of effect.’ Normally, the patch neuroscience in the mood and anxiety CBT might be the preferred method
questioned how strong is to be applied to al- disorders program at the National In- for treating pediatric OCD, especially in
the warnings on the label would be. ternating areas of the child’s thighs each stitute of Mental Health. patients without a history of attention-
Sensitization can occur with any medica- morning and removed later that day. But in In the study, 112 patients were ran- deficit hyperactivity disorder or major
tion delivered using a transdermal patch. the provocation study, patches were applied domized to receive sertraline (Zoloft), depression, because the availability of a
People sometimes develop antibodies to to a single area and left on continuously for cognitive-behavioral therapy (CBT), a CBT therapist will vary depending on
the medication in transdermal patches, and days at a time, and 13% of patients did de- combination of the two modalities, or geographic location and the fact that
when they are later challenged with an oral velop sensitivity. placebo for 12 weeks. Patients were there are “tremendous site differences
version of the medication, they may expe- For that reason, the label of the product treated at one of three sites, and were in CBT,” he said.
rience an allergic reaction. Theoretically, as it will be released contains advice for enrolled primarily at two of the sites “This recommendation only applies
this could prevent a child who had used the physicians on how to recognize and manage ( JAMA 2004;292:1969-76). to the case where you have access to a
methylphenidate patch from ever taking an sensitization. Redness at the patch site is “There were robust site differences in very skilled CBT therapist who has
oral form of the medication. very common and does not by itself indi- the response to treatment,” he said. worked with pediatric anxiety disor-
Dr. Laughren said such a sensitization re- cate sensitization. But if there is something “When you look very carefully at the ders,” Dr. Pine explained.
action had never been seen in 765 patients beyond redness—such as edema, papules, or data that are published, what you see An SSRI should be used if a skilled
exposed to methylphenidate patches in short- vesicles—a dermatologist would need to ex- was that one site had a massive re- CBT therapist is not available or if a
term trials. In one case that had been thought amine that child to determine whether sen- sponse to CBT and there was no ben- child has a severe anxiety disorder and
to involve sensitization, further study showed sitization had actually occurred. efit of adding an SSRI to CBT.” The will not undergo the crucial part of
that sensitization did not occur. However, a The patch will be available in four dosages: other site had a “very weak” response CBT that involves exposure to the
separate provocation study with treatment 10 mg, 15 mg, 20 mg, and 30 mg. ■ to CBT, an “okay” response to an SSRI, feared stimulus, he advised. ■

C L I N I C A L C A P S U L E S crease in the mean number of chromo- of Faculdade de Ciências Médicas da San-

somal abnormalities, from 1.7 per 50 cells ta Casa in São Paolo, Brazil, compared the
Borderline Traits Tracked in Teens more research is needed on the hetero- to 5.1 per 50 cells. They also showed a 4.3- outcomes of 30 adolescents who received
Borderline personality disorder appears geneity of BPD, the investigators noted. fold increase in the mean number of sis- specialized prenatal medical care and psy-
to encompass a much broader range of The existence of the four BPD factors ter chromatid exchanges (the number of choeducational support with those of 39
psychopathology in adolescent inpatients that appear to differ from those reported crossover events in a chromosome pair), age-matched adolescents who received
than in hospitalized adults, reported Dr. for similar studies in adults raises “the from 6.1 to 26.3, and a 2.4-fold increase in standard prenatal care only. All of the
Daniel F. Becker of the University of Cal- question whether BPD is different in its na- micronuclei frequencies per 1,000 cells, young women in the study were 18 years
ifornia, San Francisco, and his colleagues. ture and underlying structure in adoles- from 3.6 to 8.5. old or younger at the time of conception
The investigators interviewed 123 ado- cents,” the authors wrote. Despite the small sample size, the in- and gave birth in the maternity ward of
lescent inpatients, aged 13-18 years, who vestigators said, their study was “remark- the same hospital between July 1, 2004,
were a mean age of 15.9 years. Most (104) Methylphenidate and Cell Abnormalities able in the consistency of the increase of and June 30, 2005.
were white; 67 (54%) were boys (Compr. Methylphenidate is associated with signif- every type of cytogenetic end point mon- No significant differences were found
Psychiatry 2006;47:99-105). icant increases in cell abnormalities when itored, in every child receiving the drug.” between the two groups with respect to
Based on interviews, borderline per- given to children at therapeutic levels, re- The study opens the door for further larg- marital status or relationship with the ba-
sonality disorder (BPD) was diagnosed in ported Dr. Randa A. El-Zein of the Uni- er studies that address these issues in order bies’ fathers, Ms. Melhado said. More
65 adolescents—45% of boys and 65% of versity of Texas M. D. Anderson Cancer to establish the safety of methylphenidate, than half of the young women in both
girls—and four factors associated with Center, Houston, and colleagues. as well as possible replacement drugs, for groups were not married at the time of
BPD presentation accounted for 67% of Data from 12 children showed significant treating ADHD, they said. the study.
the overall variance. increases in several genotoxic end points af- The psychoeducational support com-
Factor 1 reflected negative or self-dep- ter 3 months of daily treatment with Psychosocial Support, Pregnant Teens ponent included group and individual ses-
recating aspects of BPD presentation, such methylphenidate. The children, whose av- Pregnant adolescents who receive inter- sions with a team of providers—including
as suicidal threats and gestures, and feel- erage age was 9 years, received doses rang- disciplinary prenatal and postpartum mental health professionals, obstetricians,
ings of emptiness or boredom. Factor 2 ing from 20 mg/day to 54 mg/day (Cancer care and psychosocial support have low- and pediatricians—focusing on such top-
covered affective dysregulation or irri- Letters 2005;230:284-91). er rates of rapid pregnancy recurrence, ics as self-esteem, contraception, relation-
tability, including uncontrolled anger. Fac- Peripheral blood lymphocyte samples Amanda Melhado reported at the annu- ships, and infant development.
tor 3 reflected interpersonal problems, were collected from the children at base- al meeting of the Society for Adolescent As of March 2006, the rate of pregnancy
such as unstable relationships. Factor 4 re- line and after 3 months of treatment and Medicine. recurrence among the young women who
flected impulsiveness. evaluated for cell abnormalities. In a prospective study of a “global care” received the intervention was 3%, com-
These factors suggest that BPD in teens Compared with baseline values, the model, Ms. Melhado, Dr. Maria José Car- pared with 15% in the standard care group.
may be associated with Axis I disorders, and children demonstrated a threefold in- valho Sant’Anna, and Dr. Verônica Coates —Heidi Splete with staff reports