Abilify Clinical Trials and Studies
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Abilify Clinical Trials and Studies
The efficacy of Abilify (aripiprazole) in the treatment of schizophrenia was evaluated in four short-term (4- and 6-week), placebo-controlled trials of acutely relapsed inpatients who predominantly met DSM-III/IV criteria for schizophrenia. Three of the four trials were able to distinguish aripiprazole from placebo, but one study, the smallest, did not. Three of these studies also included an active control group consisting of either risperidone (one trial) or haloperidol (two trials), but they were not designed to allow for a comparison of Abilify and the active comparators.
In the three 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 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 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, 15, 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 fourth study, a 4-week trial (n-103) comparing Abilify in a range of 5 to 30 mg/day or haloperidol 5 to 20 mg/day to placebo, haloperidol was superior to placebo, in the Brief Psychiatric Rating Scale (BPRS), a multi-item inventory of general psycopathology 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 15-mg, 20-mg, and 30-mg daily Abilify doses was established in two studies for each dose, whereas the efficacy of the 10-mg dose was established in one study.
There was no evidence in any study that the higher Abilify dose groups offered any advantage over the lowest dose group.
An examination of population subgroups did not reveal any clear evidence of differential responsiveness to Abilify on the basis of age, gender, or race.
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