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An Open-Label Trial of Escitalopram in Pervasive Developmental Disorders

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ABSTRACT

Objective

To assess the effect of escitalopram in the treatment of pervasive developmental disorders (PDDs).

Method

This 10-week study had a forced titration, open-label design. Twenty-eight subjects (mean age 125.1 ± 33.5 months) with a PDD received escitalopram at a dose that increased weekly to a maximum dose of 20 mg as tolerated. The Aberrant Behavior Checklist-Community Version (ABC-CV) and the Clinical Global Impression scale (CGI) were used to assess outcome.

Results

There was significant improvement in ABC-CV Irritability Subscale Scores (baseline mean 20.5 ± 5.9 to final mean 10.9 ± 7.2; p ≤ .001) and in the other ABC-CV Subscales. Improvement on Clinical Global Improvement Scale severity rating was also significant (baseline mean 5.2 ± 1.0 to final mean 4.6 ± 1.2; p ≤ .001). Twenty-five percent of the subjects responded at a dose less than 10 mg and did not tolerate the 10-mg dose, and an additional 36% responded at a dose greater than or equal to 10 mg. Final dose was unrelated to weight and only weakly correlated with age.

Conclusions

This open-label study found escitalopram to be useful in treating some difficulties common in PDDs. A wide variability in dose was found that could not be accounted for by weight and only partially by age. The study provides information useful for the design of double-blind, placebo-controlled studies of escitalopram in PDDs.

Section snippets

Subjects

A sample of 28 subjects (25 males and 3 females) (Table 1) between the ages of 6 and 17 years of age (mean 125.1 ± 33.5 months) who fulfilled criteria for a PDD (20 subjects with an autistic disorder, 5 subjects with Asperger's disorder, 3 subjects with PDD, not otherwise specified) by all three of the following: Autism Diagnostic Interview-Revised (ADI-R) (Lord et al., 1994), Autism Diagnostic Observation Schedule (ADOS) (Lord et al., 2000), and DSM-IV criteria used by a psychiatrist

RESULTS

Thirty-three subjects were assessed for participation in the study. Three subjects were excluded from the study when it was determined that the subjects were below the necessary inclusion score on the ABC-CV Irritability Subscale. Two subjects were excluded by ADI/ADOS testing (not thought to have a PDD after testing). Twenty-three of 28 subjects were able to finish the 10 weeks of the study. The other five subjects did not finish the study for various reasons. Two had a good response to

DISCUSSION

This prospective, open-label study of escitalopram suggested that this medication is useful for the treatment of some symptoms of PDDs. The responder rate in this study (61%) is similar to that achieved in previous open-label studies of SSRIs in PDDs such as those of Brodkin et al. (1997) (55%), Cook et al. (1992) (65%), DeLong et al. (1998) (59%), and Hellings et al. (1996) (57%) and in placebo-controlled studies such as McDougle et al. (1996) (57%).

Of the subjects who finished the study (23),

REFERENCES (21)

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This study was funded by National Institute of Health grants K01 MH64539 (T.O.) and U19 HD35482 (E.H.C.). The authors also acknowledge the generous support of the Jean Young and Walden W. Shaw Foundation and the University of Chicago General Clinical Research Center (NIH grant M01 RR00055).

Correspondence to Dr. Thomas Owley, Department of Psychiatry, University of Chicago, MC 3077, 5841 South Maryland Avenue, Chicago, IL 60637; e-mail: [email protected].

Disclosure: Dr. Leventhal receives reseach support from Abbott, Eli Lilly, GlaxoSmithKline, Shire, Pfizer, and Forrest Laboratories; he is on the speaker's bureaus of Eli Lilly, GlaxoSmithKline, Pfizer, and Bristol-Meyers Squibb/Otsuka; and he has consulting relationships with Abbott, Eli Lilly, Janssen, McNeil, Pfizer, and GlaxoSmithKline. The other authors have no financial relationships to disclose.

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