A multiple-center, randomized, double-blind, placebo-controlled study of oral aripiprazole for treatment of adolescents with schizophrenia

Robert L Findling, Adelaide Robb, Margaretta Nyilas, Robert A. Forbes, Na Jin, Svetlana Ivanova, Ronald Marcus, Robert D. McQuade, Taro Iwamoto, William H. Carson

Research output: Contribution to journalArticle

Abstract

Objective: Aripiprazole is a dopamine partial agonist approved for use in adults for short- and long-term treatment of schizophrenia and bipolar disorder. This study was designed to examine the acute efficacy, safety, and tolerability of aripiprazole for adolescents with schizophrenia. Method: This was a 6-week multicenter, double-blind, randomized, placebo-controlled trial. Subjects 13 to 17 years old with a DSM-IV diagnosis of schizophrenia and a Positive and Negative Syndrome Scale (PANSS) total score of 70 or more were randomly assigned (1:1:1 ratio) to placebo or 10 or 30 mg/day of aripiprazole. The primary endpoint was mean change from baseline to endpoint (last observation carried forward) in PANSS total score. Assessments of safety and tolerability included spontaneously reported adverse events, extrapyramidal symptom scores, serum prolactin concentration, body weight, and metabolic measures. Results: Of 302 patients, 85% completed the 6-week study. The mean baseline PANSS score was 94.1. At the end of the study, both aripiprazole doses showed statistically significant differences from placebo in reduction in PANSS total score. Adverse events occurring in more than 5% of either aripiprazole group and with a combined incidence at least twice the rate for placebo were extrapyramidal disorder, somnolence, and tremor. Mean changes in prolactin were -8.45, -11.93, and -15.14 ng/ml for placebo and 10 mg and 30 mg of aripirazole, respectively. Mean body weight changes were -0.8, 0.0, and 0.2 kg for placebo and 10 mg and 30 mg of aripiprazole, respectively. Conclusion: Both 10- and 30-mg/day doses of aripiprazole were superior to placebo in the acute treatment of adolescents with schizophrenia. Aripiprazole was generally well tolerated.

Original languageEnglish (US)
Pages (from-to)1432-1441
Number of pages10
JournalAmerican Journal of Psychiatry
Volume165
Issue number11
DOIs
StatePublished - Nov 2008
Externally publishedYes

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Schizophrenia
Placebos
Therapeutics
Prolactin
Basal Ganglia Diseases
Body Weights and Measures
Safety
Body Weight Changes
Aripiprazole
Dopamine Agonists
Tremor
Bipolar Disorder
Diagnostic and Statistical Manual of Mental Disorders
Randomized Controlled Trials
Observation
Incidence
Serum

ASJC Scopus subject areas

  • Psychiatry and Mental health

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A multiple-center, randomized, double-blind, placebo-controlled study of oral aripiprazole for treatment of adolescents with schizophrenia. / Findling, Robert L; Robb, Adelaide; Nyilas, Margaretta; Forbes, Robert A.; Jin, Na; Ivanova, Svetlana; Marcus, Ronald; McQuade, Robert D.; Iwamoto, Taro; Carson, William H.

In: American Journal of Psychiatry, Vol. 165, No. 11, 11.2008, p. 1432-1441.

Research output: Contribution to journalArticle

Findling, Robert L ; Robb, Adelaide ; Nyilas, Margaretta ; Forbes, Robert A. ; Jin, Na ; Ivanova, Svetlana ; Marcus, Ronald ; McQuade, Robert D. ; Iwamoto, Taro ; Carson, William H. / A multiple-center, randomized, double-blind, placebo-controlled study of oral aripiprazole for treatment of adolescents with schizophrenia. In: American Journal of Psychiatry. 2008 ; Vol. 165, No. 11. pp. 1432-1441.
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T1 - A multiple-center, randomized, double-blind, placebo-controlled study of oral aripiprazole for treatment of adolescents with schizophrenia

AU - Findling, Robert L

AU - Robb, Adelaide

AU - Nyilas, Margaretta

AU - Forbes, Robert A.

AU - Jin, Na

AU - Ivanova, Svetlana

AU - Marcus, Ronald

AU - McQuade, Robert D.

AU - Iwamoto, Taro

AU - Carson, William H.

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Y1 - 2008/11

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