TRIMS Therapy Notes, Volume 5, Number 11, November 1984 Page: ATTACHMENT
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Two years ago, a team of
child development special-
ists and researchers at TRIMS
joined a nationwide study to
find out whether or not fenflur-
amine, an appetite-suppressant
drug that also lowers brain sero-
tonin, would improve the behav-
ior and learning ability of autis-
tic children and young adults.
Drs. Edward Geller, Edward
Ritvo, and Betty Jo Freeman of
the University of California at
Los Angeles had shown that the
drug helped three autistic boys
control their severely disordered
behavior and relate better to
their families and environment.
The children's plasma serotoninlevels decreased and their IQ
scores rose. After three months
without medication, however,
their serotonin levels were elevated again and their
learning and behavioral improvements were gone.
Autism is included in DSM-///1as one of the pervasive
developmental disorders-disorders in which there is a
distortion rather than only a delay in the multiple psy-
chological skills necessary for socialization, learning,
and language. Although the IQs of autistic persons
range all the way from profound retardation to superior
intelligence, most have severe learning and social
deficits, and many injure themselves involuntarily.
About 40 percent of autistic persons have blood
serotonin levels elevated to one degree or another,
which suggests a link between autism and this bio-
chemical abnormality-and the possibility that fenflur-
amine might be helpful.
The relationship of the neurotransmitter serotonin to
autism is particularly interesting to researchers-and
certainly to parents of autistic children-because
understanding the biological mechanisms of this
extremely disabling condition might contribute to
treatment knowledge, keep more autistic people out of
institutions, and, at its best, help to prevent the disorder.
As Ritvo said, the study may at least reveal subcatego-
ries of autism by showing which kinds of patients
respond to fenfluramine and which ones do not.We joined this study with 17 other centers through-
out the country. We chose 16 autistic persons for
our group; the total nationally was 150. Our partici-
pants did not have seizures and were not taking psy-
chotropic medications. Their IQs ranged from 9 on the
Merrill-Palmer developmental scale to 124 on theWechsler Adult Intelligence
Scale, their ages from nine to
24. Six participants were severe-
ly retarded, four were profound-
ly retarded; one-half of the 16
were nonverbal. All children
were evaluated by our interdis-
ciplinary team to confirm the
diagnosis and identify factors
that would exclude them from
the study.
The final report of the multi-
center collaborative study has
not yet been published, but our
study indicates so far that fen-Fenfluramine and
autism
Kay R. Lewis, M.D.
David Wood, Ph.D.
Beng T. Ho, Ph.D.
Jeannine P. Kriegel, M.S.W.
Dorothy Taylor, M.S.
November 1984We measured the participants' intellectual levels at
intervals and videotaped their behavior during play with
standard toys in the presence of a nonresponding
observer. We administered the Ritvo-Freeman Real Life
Rating scale, adaptive behavior tests, measured the
participants' height and weight, and videotaped child-
parent interactions. The parents kept a log of the chil-
dren's behavior at home.
After seven months of the first-phase study with 13
participants (several parents removed their chil-
dren from the study because the children seemed not to
be improving, or they lived too far from the clinic, or for
another reason we will explain), we have come to these
(continued on back)fluramine benefits some autis-
tic persons and not others.
Our study was conducted in
two phases. The first consisted
of two weeks of baseline testing,
followed by seven months dur-
ing which parents and profes-
sional evaluators did not know whether the participants
were taking fenfluramine or placebo. The intervals were
one month of placebo, four months of fenfluramine,
two months of placebo, in a sequence known only to
the principal investigator (Lewis).
The second phase, from which data are not yet
available, consisted of an eight-month double-blind
study with a crossover at four months. All investigators,
including Lewis, were blind during this phase.
The fenfluramine dosage was 1.5 mg/kg/day,
divided into two doses administered every 12 hours.
Fasting whole-blood serotonin was measured at each
monthly visit with the fluorometric technique of Yuwiler.
The participants' initial serotonin levels ranged from
128 to 560 ng/ml, mean 384 (normal children's levels
are 250 to 350 ng/ml, those of normal adults 150 to
250).TRIMS*THERAPY*NOTES
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Lewis, Kay R.; Wood, David; Ho, Beng T.; Kreigel, Jeannine P. & Taylor, Dorothy. TRIMS Therapy Notes, Volume 5, Number 11, November 1984, periodical, November 1984; Houston, Texas. (https://texashistory.unt.edu/ark:/67531/metapth1543220/m1/1/: accessed August 15, 2024), University of North Texas Libraries, The Portal to Texas History, https://texashistory.unt.edu; crediting UNT Libraries Government Documents Department.