In the four positive trials for ABILIFY, four primary measures were used for assessing psychiatric signs and symptoms. The Positive and Negative Syndrome Scale (PANSS) is a multi-item inventory of general psychopathology used to evaluate the effects of drug treatment in Schizophrenia. The PANSS positive subscale is a subset of items in the PANSS that rates seven positive symptoms of Schizophrenia (delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility). The PANSS negative subscale is a subset of items in the PANSS that rates seven negative symptoms of Schizophrenia (blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity/flow of conversation, stereotyped thinking). The Clinical Global Impression (CGI) assessment reflects the impression of a skilled observer, fully familiar with the manifestations of Schizophrenia, about the overall clinical state of the patient.

In a 4-week trial (n=414) comparing two fixed doses of ABILIFY (15 mg/day or 30 mg/day) and haloperidol (10 mg/day) to placebo, both doses of ABILIFY were superior to placebo in the PANSS total score, PANSS positive subscale, and CGI-severity score. In addition, the 15 mg dose was superior to placebo in the PANSS negative subscale.

In a 4-week trial (n=404) comparing two fixed doses of ABILIFY (20 mg/day or 30 mg/day) and risperidone (6 mg/day) to placebo, both doses of ABILIFY were superior to placebo in the PANSS total score, PANSS positive subscale, PANSS negative subscale, and CGI-severity score.

In a 6-week trial (n=420) comparing three fixed doses of ABILIFY (10 mg/day, 15 mg/day, or 20 mg/day) to placebo, all three doses of ABILIFY were superior to placebo in the PANSS total score, PANSS positive subscale, and the PANSS negative subscale.

In a 6-week trial (n=367) comparing three fixed doses of ABILIFY (2 mg/day, 5 mg/day, or 10 mg/day) to placebo, the 10 mg dose of ABILIFY was superior to placebo in the PANSS total score, the primary outcome measure of the study. The 2 mg and 5 mg doses did not demonstrate superiority to placebo on the primary outcome measure.

In a fifth study, a 4-week trial (n=103) comparing ABILIFY in a range of 5 mg/day to 30 mg/day or haloperidol 5 mg/day to 20 mg/day to placebo, haloperidol was superior to placebo, in the Brief Psychiatric Rating Scale (BPRS), a multi-item inventory of general psychopathology traditionally used to evaluate the effects of drug treatment in psychosis, and in a responder analysis based on the CGI-severity score, the primary outcomes for that trial. ABILIFY was only significantly different compared to placebo in a responder analysis based on the CGI-severity score.

Thus, the efficacy of 10 mg, 15 mg, 20 mg, and 30 mg daily doses was established in two studies for each dose. Among these doses, there was no evidence that the higher dose groups offered any advantage over the lowest dose group of these studies.

An examination of population subgroups did not reveal any clear evidence of differential responsiveness on the basis of age, gender, or race.

A longer-term trial enrolled 310 inpatients or outpatients meeting DSM-IVcriteria for Schizophrenia who were, by history, symptomatically stable on other antipsychotic medications for periods of 3 months or longer. These patients were discontinued from their antipsychotic medications and randomized to ABILIFY 15 mg/day or placebo for up to 26 weeks of observation for relapse. Relapse during the double-blind phase was defined as CGI-Improvement score of ≥ 5 (minimally worse), scores ≥ 5 (moderately severe) on the hostility or uncooperativeness items of the PANSS, or ≥ 20% increase in the PANSS total score. Patients receiving ABILIFY 15 mg/day experienced a significantly longer time to relapse over the subsequent 26 weeks compared to those receiving placebo.

Pediatric

The efficacy of ABILIFY(aripiprazole)in the treatment of Schizophrenia in pediatric patients (13 to 17 years of age) was evaluated in one 6-week, placebo-controlled trial of outpatients who met DSM-IV criteria for Schizophrenia and had a PANSS score ≥ 70 at baseline. In this trial (n=302) comparing two fixed doses of ABILIFY (10 mg/day or 30 mg/day) to placebo, ABILIFY was titrated starting from 2 mg/day to the target dose in 5 days in the 10 mg/day treatment arm and in 11 days in the 30 mg/day treatment arm. Both doses of ABILIFY were superior to placebo in the PANSS total score, the primary outcome measure of the study. The 30 mg/day dosage was not shown to be more efficacious than the 10 mg/day dose.

Bipolar Disorder

Adults

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