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CATIE Phase I Helps Clinicians Tailor Schizophrenia Treatment

...Aripiprazole (Abilify), Lieberman noted, was not approved until November 2002, so it could not be in Phase I.

It was, however, added to Phase III of the study, so there will be descriptive data on how it does compare with the other medicines.

The dose range for each medication was chosen based on the advice of experienced clinicians, clinical practice patterns from national pharmacy databases and discussions with the drugs' manufacturers.

As described in the New England Journal of Medicine, the primary outcome measure for Phase I of the CATIE trial was all-cause treatment discontinuation, which reflects both clinicians' and patients' judgments about efficacy and tolerability (Lieberman et al., 2005).

Secondary outcomes were the specific reasons for treatment discontinuation (e.g., inefficacy or intolerability owing to such side effects as weight gain, extrapyramidal signs or sedation as judged by the patient's clinician) and scores on the Positive and Negative Syndrome Scale (PANSS) and the Clinical Global Impression (CGI) scale.

Robert Baker, M.D., medical director at Eli Lilly and Company, explained that CATIE showed olanzapine "to be more effective on the [all-cause] discontinuation rate than other medications studied," and it had favorable findings for olanzapine "in terms of duration of suc...

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