The International Journal of Neuropsychopharmacology

Efficacy and safety of aripiprazole vs. haloperidol for long-term maintenance treatment following acute relapse of schizophrenia

Siegfried Kasper a1c1, Mark N. Lerman a2, Robert D. McQuade a3, Anutosh Saha a4, William H. Carson a5, Mirza Ali a4, Donald Archibald a3, Gary Ingenito a4, Ronald Marcus a6 and Teresa Pigott a7
a1 Department of General Psychiatry, University of Vienna, Vienna, Austria
a2 Alexian Brothers Behavioral Health Hospital, Hoffman Estates, IL, USA
a3 Bristol-Myers Squibb, Wallingford, CT, USA
a4 Otsuka Maryland Research Institute, Rockville, MD, USA
a5 Otsuka America Pharmaceutical, Inc., Princeton, NJ, USA
a6 Bristol-Myers Squibb, Wallingford, CT, USA
a7 University of Florida, Gainesville, FL, USA

Article author query
kasper s   [PubMed][Google Scholar] 
lerman m   [PubMed][Google Scholar] 
mcquade r   [PubMed][Google Scholar] 
saha a   [PubMed][Google Scholar] 
carson w   [PubMed][Google Scholar] 
ali m   [PubMed][Google Scholar] 
archibald d   [PubMed][Google Scholar] 
ingenito g   [PubMed][Google Scholar] 
marcus r   [PubMed][Google Scholar] 
pigott t   [PubMed][Google Scholar] 


Aripiprazole is a novel atypical antipsychotic for the treatment of schizophrenia. It is a D2 receptor partial agonist with partial agonist activity at 5-HT1A receptors and antagonist activity at 5-HT2A receptors. The long-term efficacy and safety of aripiprazole (30 mg/d) relative to haloperidol (10 mg/d) were investigated in two 52-wk, randomized, double-blind, multicentre studies (using similar protocols which were prospectively identified to be pooled for analysis) in 1294 patients in acute relapse with a diagnosis of chronic schizophrenia and who had previously responded to antipsychotic medications. Aripiprazole demonstrated long-term efficacy that was comparable or superior to haloperidol across all symptoms measures, including significantly greater improvements for PANSS negative subscale scores and MADRS total score (p<0.05). The time to discontinuation for any reason was significantly greater with aripiprazole than with haloperidol (p=0.0001). Time to discontinuation due to adverse events or lack of efficacy was significantly greater with aripiprazole than with haloperidol (p=0.0001). Aripiprazole was associated with significantly lower scores on all extrapyramidal symptoms assessments than haloperidol (p<0.001). In summary, aripiprazole demonstrated efficacy equivalent or superior to haloperidol with associated benefits for safety and tolerability. Aripiprazole represents a promising new option for the long-term treatment of schizophrenia.

(Received October 14 2002)
(Reviewed March 25 2003)
(Revised July 9 2003)
(Accepted July 13 2003)

Key Words: Aripiprazole; atypical antipsychotic; dopamine partial agonist; long-term treatment; schizophrenia.

c1 O. Univ. Prof Dr Dr h.c. S. Kasper, Department of General Psychiatry, University of Vienna, A-1090 Vienna, Währinger Gürtel 18-20, Austria. Tel.: +43-1-40400 3568 Fax: +43-1-40400 3099 E-mail: