Effect of aripiprazole augmentation of clozapine in schizophrenia: A double-blind, placebo-controlled study

• Published in: Schizophrenia research Vol. 127; no. 1; pp. 93 - 99
• Main Authors: Muscatello, Maria Rosaria A, Bruno, Antonio, Pandolfo, Gianluca, Micò, Umberto, Scimeca, Giuseppe, Di Nardo, Floriana, Santoro, Vincenza, Spina, Edoardo, Zoccali, Rocco A
• Format: Journal Article
• Language: English
• Published: Amsterdam Elsevier B.V 01.04.2011; Elsevier
• Subjects: Adult; Adult and adolescent clinical studies; Analysis of Variance; Antipsychotic Agents - therapeutic use; Aripiprazole; Augmentation; Biological and medical sciences; Clozapine; Clozapine - therapeutic use; Double-Blind Method; Drug Interactions; Female; Humans; Male; Medical sciences; Neuropharmacology; Pharmacology. Drug treatments; Piperazines - therapeutic use; Psychiatry; Psycholeptics: tranquillizer, neuroleptic; Psychology. Psychoanalysis. Psychiatry; Psychopathology. Psychiatry; Psychopharmacology; Psychoses; Quinolones - therapeutic use; Schizophrenia; Schizophrenia - drug therapy; Time Factors; Augmentation; Schizophrenia; Clozapine; Aripiprazole; 5-HT2A serotonin receptor; Human; Partial agonist; Dibenzodiazepine derivatives; Atypical antipsychotic; Neuroleptic; Psychotropic; Quinolinone derivatives; Psychosis; D2 Dopamine receptor; 5-HT1A Serotonine receptor; Placebo; Double blind study; Antagonist
• ISSN: 0920-9964; 1573-2509
• DOI: 10.1016/j.schres.2010.12.011

Abstract The simultaneous prescription of two or more antipsychotic drugs in combination is a common treatment strategy for those patients who have demonstrated a suboptimal response to clozapine; nevertheless, evidence suggesting potential advantages of combination treatment with clozapine plus one antipsychotic in terms of efficacy and tolerability are still sparse. The present 24-week double-blind, randomized, placebo-controlled trial of adjunctive aripiprazole to clozapine therapy in schizophrenia was aimed to explore the efficacy of aripiprazole add-on pharmacotherapy on clinical symptomatology and cognitive functioning in a sample of patients with treatment-resistant schizophrenia receiving clozapine. After clinical and neurocognitive assessments patients were randomly allocated to receive, in a double-blind design, either up to 15 mg/day of aripiprazole or a placebo. A final sample of thirty-one patients completed the study. The results obtained indicate that aripiprazole added to stable clozapine treatment showed a beneficial effect on the positive and general psychopathological symptomatology in a sample of treatment-resistant schizophrenia patients. Regarding executive cognitive functions, aripiprazole augmentation of clozapine had no significant effects. The findings provide evidence that aripiprazole augmentation of clozapine treatment is well-tolerated and may be of benefit for patients who are partially responsive to clozapine monotherapy; further double-blind, placebo-controlled trials in a larger number of patients are required to evaluate the therapeutic potential of aripiprazole augmentation of clozapine.