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Aripiprazole versus haloperidol in combination with clozapine for treatment-resistant schizophrenia: a 12-month, randomized, naturalistic trial.
J Clin Psychopharmacol. 2013 Aug; 33(4):533-7.JC

Abstract

BACKGROUND

Long-term studies for patients with resistant schizophrenia are necessary to assess the effectiveness of combination strategies on persisting positive symptoms.

AIMS AND METHODS

This multicenter, naturalistic, randomized, superiority study (ClinicalTrials.gov identifier: NCT00395915) aimed to compare clinical efficacy and tolerability of haloperidol versus aripiprazole as combination treatment with clozapine in patients with resistant schizophrenia.

RESULTS

One hundred six patients were followed up for 12 months. After 12 months, the proportion of patients who discontinued treatment was not significantly different between aripiprazole and haloperidol (37% vs 28%, respectively; P = 0.431). The change in the Brief Psychiatric Rating Scale score was similar in the aripiprazole and haloperidol groups (-7.0 vs -7.9, respectively; P = 0.389), whereas the tolerability total score decreased significantly more in the aripiprazole group (-7.2 vs -2.3; P = 0.008).

CONCLUSIONS

While the effectiveness of clozapine augmentation with a second antipsychotic agent is not clearly demonstrated yet, results from this study suggest that augmentation with aripiprazole offers no substantial benefit over haloperidol in efficacy. Aripiprazole was perceived more tolerable than haloperidol, but it is uncertain how this finding may translate into the real world of clinical practice.

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Authors+Show Affiliations

Cipriani A
Section of Psychiatry, Department of Public Health and Community Medicine, University of Verona, Italy. andrea.cipriani@univr.it
Accordini S
No affiliation info available
Nosè M
No affiliation info available
Purgato M
No affiliation info available
Girlanda F
No affiliation info available
Tansella M
No affiliation info available
Barbui C
No affiliation info available

MeSH

Antipsychotic AgentsAripiprazoleClozapineDisease-Free SurvivalDrug ResistanceDrug Therapy, CombinationHaloperidolHumansItalyKaplan-Meier EstimateLinear ModelsMultivariate AnalysisPiperazinesProportional Hazards ModelsPsychiatric Status Rating ScalesQuinolonesSchizophreniaSchizophrenic PsychologyTime FactorsTreatment Outcome

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Pragmatic Clinical Trial

Language

eng

PubMed ID

23775051

Clinical Trial Links

Clinical trial which this article describes

Citation

Cipriani, Andrea, et al. "Aripiprazole Versus Haloperidol in Combination With Clozapine for Treatment-resistant Schizophrenia: a 12-month, Randomized, Naturalistic Trial." Journal of Clinical Psychopharmacology, vol. 33, no. 4, 2013, pp. 533-7.
Cipriani A, Accordini S, Nosè M, et al. Aripiprazole versus haloperidol in combination with clozapine for treatment-resistant schizophrenia: a 12-month, randomized, naturalistic trial. J Clin Psychopharmacol. 2013;33(4):533-7.
Cipriani, A., Accordini, S., Nosè, M., Purgato, M., Girlanda, F., Tansella, M., & Barbui, C. (2013). Aripiprazole versus haloperidol in combination with clozapine for treatment-resistant schizophrenia: a 12-month, randomized, naturalistic trial. Journal of Clinical Psychopharmacology, 33(4), 533-7. https://doi.org/10.1097/JCP.0b013e318296884f
Cipriani A, et al. Aripiprazole Versus Haloperidol in Combination With Clozapine for Treatment-resistant Schizophrenia: a 12-month, Randomized, Naturalistic Trial. J Clin Psychopharmacol. 2013;33(4):533-7. PubMed PMID: 23775051.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Aripiprazole versus haloperidol in combination with clozapine for treatment-resistant schizophrenia: a 12-month, randomized, naturalistic trial. AU - Cipriani,Andrea, AU - Accordini,Simone, AU - Nosè,Michela, AU - Purgato,Marianna, AU - Girlanda,Francesca, AU - Tansella,Michele, AU - Barbui,Corrado, PY - 2013/6/19/entrez PY - 2013/6/19/pubmed PY - 2014/2/19/medline SP - 533 EP - 7 JF - Journal of clinical psychopharmacology JO - J Clin Psychopharmacol VL - 33 IS - 4 N2 - BACKGROUND: Long-term studies for patients with resistant schizophrenia are necessary to assess the effectiveness of combination strategies on persisting positive symptoms. AIMS AND METHODS: This multicenter, naturalistic, randomized, superiority study (ClinicalTrials.gov identifier: NCT00395915) aimed to compare clinical efficacy and tolerability of haloperidol versus aripiprazole as combination treatment with clozapine in patients with resistant schizophrenia. RESULTS: One hundred six patients were followed up for 12 months. After 12 months, the proportion of patients who discontinued treatment was not significantly different between aripiprazole and haloperidol (37% vs 28%, respectively; P = 0.431). The change in the Brief Psychiatric Rating Scale score was similar in the aripiprazole and haloperidol groups (-7.0 vs -7.9, respectively; P = 0.389), whereas the tolerability total score decreased significantly more in the aripiprazole group (-7.2 vs -2.3; P = 0.008). CONCLUSIONS: While the effectiveness of clozapine augmentation with a second antipsychotic agent is not clearly demonstrated yet, results from this study suggest that augmentation with aripiprazole offers no substantial benefit over haloperidol in efficacy. Aripiprazole was perceived more tolerable than haloperidol, but it is uncertain how this finding may translate into the real world of clinical practice. SN - 1533-712X UR - https://www.unboundmedicine.com/medline/citation/23775051/Aripiprazole_versus_haloperidol_in_combination_with_clozapine_for_treatment_resistant_schizophrenia:_a_12_month_randomized_naturalistic_trial_ L2 - https://doi.org/10.1097/JCP.0b013e318296884f DB - PRIME DP - Unbound Medicine ER -