Aripiprazole once-monthly for treatment of schizophrenia: double-blind, randomised, non-inferiority study
| Autor: | David P. Walling, Na Jin, W. Wolfgang Fleischhacker, Pamela Perry, Ross A. Baker, Robert D. McQuade, B. Johnson, William H. Carson, Raymond Sanchez, Timothy Peters-Strickland, Anna Eramo, John M. Kane |
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| Rok vydání: | 2014 |
| Předmět: |
medicine.medical_specialty
Assay sensitivity Relapse rate medicine.disease 030227 psychiatry law.invention Double blind 03 medical and health sciences Psychiatry and Mental health 0302 clinical medicine Non inferiority Randomized controlled trial Schizophrenia law Internal medicine medicine Aripiprazole Psychiatry Trial registration Psychology 030217 neurology & neurosurgery medicine.drug |
| Zdroj: | British Journal of Psychiatry. 205:135-144 |
| ISSN: | 1472-1465 0007-1250 |
| DOI: | 10.1192/bjp.bp.113.134213 |
| Popis: | BackgroundLong-acting injectable formulations of antipsychotics are treatment alternatives to oral agents.AimsTo assess the efficacy of aripiprazole once-monthly compared with oral aripiprazole for maintenance treatment of schizophrenia.MethodA 38-week, double-blind, active-controlled, non-inferiority study; randomisation (2:2:1) to aripiprazole once-monthly 400 mg, oral aripiprazole (10–30 mg/day) or aripiprazole once-monthly 50mg (a dose below the therapeutic threshold for assay sensitivity). (Trial registration: clinicaltrials.gov, NCT00706654.)ResultsA total of 1118 patients were screened, and 662 responders to oral aripiprazole were randomised. Kaplan–Meier estimated impending relapse rates at week 26 were 7.12% for aripiprazole once-monthly 400mg and 7.76% for oral aripiprazole. This difference (−0.64%, 95% CI −5.26 to 3.99) excluded the predefined non-inferiority margin of 11.5%. Treatments were superior to aripiprazole once-monthly 50mg (21.80%, P⩽0.001).ConclusionsAripiprazole once-monthly 400mg was non-inferior to oral aripiprazole, and the reduction in Kaplan–Meier estimated impending relapse rate at week 26 was statistically significant v. aripiprazole once-monthly 50 mg. |
| Databáze: | OpenAIRE |
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