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Switching patients to aripiprazole from other antipsychotic agents: a multicenter randomized study

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Abstract

Rationale

Switching patients from one antipsychotic to another can lead to tolerability problems or transient symptom exacerbations. It is important to compare switching strategies to determine which methods produce the best possible patient outcomes.

Objective

To investigate the efficacy, safety and tolerability of three dosing strategies for switching chronic, stable patients with schizophrenia from current oral antipsychotic monotherapy to once-daily oral aripiprazole monotherapy.

Method

Patients in this 8-week, open-label, outpatient study were randomized to: 1) immediate initiation of 30 mg/day aripiprazole with simultaneous immediate discontinuation of current antipsychotic; 2) immediate initiation of 30 mg/day aripiprazole while tapering off current antipsychotic over 2 weeks; or 3) up-titrating aripiprazole to 30 mg/day over 2 weeks, while simultaneously tapering off current antipsychotic. Efficacy assessments included PANSS, CGI-S, and CGI-I scores. Safety assessments included: adverse events (AEs) recording, evaluation of extrapyramidal symptoms (EPS), vital signs, ECG, and clinical laboratory tests.

Results

Efficacy with aripiprazole was maintained during the study with numerical improvements compared with baseline in all three groups. The overall incidence of AEs was broadly comparable across all groups, and AEs were generally mild to moderate in severity and time-limited. Discontinuations due to AEs were comparable across the groups. No deterioration in EPS occurred in any group. The reduction in body weight and plasma prolactin levels following switch to aripiprazole were comparable across the three groups.

Conclusion

Any of the three strategies evaluated can be used safely for switching patients to aripiprazole from antipsychotic monotherapy. Furthermore, patients' symptoms may continue to improve after switching to aripiprazole.

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Acknowledgements

This study was supported by Bristol-Myers Squibb and Otsuka Pharmaceutical Co.

Members of the Aripiprazole Study Group: S. Altinsan, Pharmacology Research Corporation, Reno, Nev., USA; T.M. Antin, PACT Atlanta LLC, Decatur, Ga., USA; M. Banov, Northwest Behavioral Research Center, Marietta, Ga., USA; B. Bastani, North Coast Clinical Trials, Beachwood, Ohio, USA; R. Bielski, Institute for Health Studies, Okemos, Mich., USA; J. Carr, Affiliated Research Institute, Claremont, Calif., USA; S. Cheren, Stanley Cheren, MD, Inc., Brookline, Mass., USA; A. Cutler, Coordinated Research of Florida, Inc., Winter Park, Fla., USA; J.M. Ferguson, Pharmacology Research Clinic, Salt Lake City, Utah, USA; D.L. Fogelson, Pacific Psychopharmacology Research, Santa Monica, Calif., USA; A.M. Freeman, III, Louisiana State University Medical Center, Shreveport, La., USA; H.L. Goldberg, Kauai Community Mental Health Center, Lihue, Hawaii, USA; M.S. Hale, New Britain General Hospital, New Britain, Conn., USA; M.B Hamner, Ralph H. Johnson VA Medical Center, Charleston, S.C., USA; J.T. Hartford, Hartford Research Group, Cincinnati, Ohio, USA; I.S. Kolin, Irving S. Kolin, MD, PA, Winter Park, Fla., USA; G.L. Larson, VA Medical Center, Milwaukee, Wisc., USA; D. Mee-Lee, Hawaii Clinical Research Center, Honolulu, Hawaii, USA; A.L. Miller, University Health Center-Downtown, San Antonio, Tex., USA; J. Miller, Clinical Neuroscience Solutions, West Palm Beach, Fla., USA; J.J. Pahl, Pahl Brain Associates, Inc., Oklahoma City, Okla., USA; R.L. Pearlman, Sisters of Charity Medical Center, Staten Island, N.Y., USA; D.A. Sack, The Institute of Psychopharmacology, Cerritos, Calif., USA; J.S. Simon, Northbrooke Research Center, Brown Deer, Wisc., USA; K. Sokolski, Affiliated Research Institute, Santa Ana, Calif., USA; V. Spratlin, Mercer University, Atlanta, Ga., USA; T.K. Tran-Johnson, California Neuropsychopharmacology, San Diego, Calif., USA; M.M. Viner, Pharmacology Research Corporation, Reno, Nev., USA; S.A. West, Psychiatric Institute of Florida, PA, Orlando, Fla., USA; C. Wronski, Affiliated Research Institute, Santa Ana, Calif., USA; D.L. Zimbroff, Pacific Clinical Research, San Bernardino, Calif., USA.

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Correspondence to Daniel E. Casey.

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Casey, D.E., Carson, W.H., Saha, A.R. et al. Switching patients to aripiprazole from other antipsychotic agents: a multicenter randomized study. Psychopharmacology 166, 391–399 (2003). https://doi.org/10.1007/s00213-002-1344-3

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