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Phase 2, known as the oral stabilization phase (4-12 weeks in duration), consisted of biweekly assessments to stabilize subjects on oral aripiprazole (10-30 mg/d). In phase 1 (oral conversion phase), patients not currently treated with oral aripiprazole were cross-titrated to aripiprazole monotherapy over a 4 to 6 week period. The study comprised a screening phase, used to assess eligibility, followed by 4 treatment phases. These included (1) clinical worsening defined by Clinical Global Impression improvement (CGI-I) score of ≥ 5 and an increase in score on any of the following 4 Positive and Negative Syndrome Scale (PANSS) items (conceptual disorganization, hallucinatory behavior, suspiciousness, or unusual thought content) to a score > 4 with an absolute increase ≥ 2 on that specific item or an increase > 4 on these PANSS items and an absolute increase ≥ 4 on the combined score (2) hospitalization as a result of worsening of psychotic symptoms (3) risk of suicide (Clinical Global Impression-Severity Scale (CGI-SS) score of 4 or 5 on part 1 or a score of 6 or 7 on part 2) or (4) violent behavior causing clinically significant self-injury, injury to another person, or property damage. A psychotic exacerbation or impending relapse was defined by meeting any or all of the 4 criteria at any time during phase 4.

The primary outcome measure was time to exacerbation of psychotic symptoms/impending relapse in subjects stabilized on aripiprazole LAI for at least 12 weeks and randomized to treatment with aripiprazole LAI or placebo. 13 In addition, partial 5HT1A agonism produces anxiolytic effects as well. 12 Partial 5HT1A agonism has also been associated with a reduction in EPS and has been shown to enhance dopaminergic neurotransmission in frontocortical regions of the brain, which are often deficient in dopamine in patients with schizophrenia, thereby improving both negative and cognitive symptoms of schizophrenia. 12 Additionally, 5HT2A antagonism yields an increase in dopaminergic release in the mesocortical and nigrostriatal dopaminergic pathways, which may lead to improvement in the negative symptoms of schizophrenia and a reduction in the risk of EPS, respectively.

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12 Partial agonism at postsynaptic D2 receptors may reduce the risk of extrapyramidal side effects (EPS) and hyperprolactinemia, which are a result of full D2 receptor antagonism. 12 In regions of the brain with hyperdopaminergic activity, such as the mesolimbic system, aripiprazole reduces dopamine transmission, thereby treating positive symptoms of schizophrenia. 12 Effects at D2 autoreceptors may result in reduced dopamine synthesis and release, ultimately leading to a reduction in dopaminergic neurotransmission. 10 Aripiprazole is hypothesized to act as a partial agonist at both D2 autoreceptors and postsynaptic receptors. 11 Similar to other antipsychotics, the exact mechanism of action of aripiprazole for the treatment of schizophrenia is unknown but is believed to involve D2 and 5HT1A receptor partial agonism and 5HT2A receptor antagonism. Aripiprazole is the first antipsychotic agent with D2 partial agonist properties.