General Information

Abilify (aripiprazole) is an orally administered drug approved in November 2002 for the treatment of schizophrenia. It is a dopamine partial agonist and a seratonin antagonist.

Abilify oral tablets are available in 10mg, 15mg, 20mg, and 30mg doses. The 15mg strength is the recommended starting and effective dose.

Clinical Results

Four short-term, placebo-controlled clinical trials were conducted with Abilify in acute replapsed inpatients with schizophrenia. In three of the four trials, efficacy was measured by the Positive and Negative Syndrome Scale (PANSS) and the Clinical Global Impression Severity of Illness Score (CGI-S). In the three trials, Abilify was statistically superior to placebo using these measures.

In the fourth trial, efficacy was measured by a responder analysis based on the CGI-S and the change in Brief Psychiatric Rating Scale (BPRS). Abilify was statistically superior to placebo based on the CGI-S, but not in the BPRS measure.

Clinical efficacy was demonstrated by the 15mg, 20mg and 30mg doses in two trials each. Clinical efficacy was shown for the 10mg dose in one trial. No evidence of clinical superiority was shown by the higher doses compared to the lowest dose.

Side Effects

The following are some of the adverse events that were experienced in clinical trials by 2% or more of subjects receiving aripiprazole:

Headache

Anxiety

Nausea

Vomiting

Constipation

Insomnia

Lightheadedness

Somnolence (sleepiness)

Akathisia (condition of motor restlessness)

No siginficant differences were found in incidence of discontinuation due to adverse events experienced by the aripiprazole group compared to the placebo group.

Note: Neuroleptic malignant syndrome (NMS), a rare but sometimes fatal condition, has been associated with antipsychotic drugs, including Abilify. In addition, tardive dyskinesia (TD) has also been associated with antipsychotic drugs.