In patients who do require chronic treatment, the smallest dose and the shortest duration of treatment producing a satisfactory clinical response should be sought.
Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Available for Android and iOS devices. The CGI-S rates the severity of mental illness on a scale of 1 (normal) to 7 (among the most extremely ill) based on the total clinical experience of the rater in treating patients with schizophrenia. Table 4 shows the proportion of Abilify Maintena-treated patients with normal and borderline fasting glucose at baseline and their changes in fasting glucose measurements.During a 52-week, open-label bipolar I disorder study in those patients who initiated Abilify Maintena treatment, 1.1% with normal baseline fasting glucose experienced a shift to high while receiving Abilify Maintena and 9.8% with borderline fasting glucose experienced a shift to high. The patient should be carefully monitored, since recurrences of NMS have been reported.A syndrome of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotic drugs. Other compulsive urges, reported less frequently, include: sexual urges, shopping, eating or binge eating, and other impulsive or compulsive behaviors. Relapse was defined as the first occurrence of one or more of the following criteria:A pre-planned interim analysis demonstrated a statistically significantly longer time to relapse in patients randomized to the Abilify Maintena group compared to placebo-treated patients and the trial was subsequently terminated early because maintenance of efficacy was demonstrated. The changes in female reproductive organs were considered secondary to the increase in prolactin serum levels. However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses.Tardive dyskinesia may remit, partially or completely, if antipsychotic treatment is withdrawn. Your doctor may occasionally change your dosing schedule.If you have never used Abilify Maintena before, your doctor may want to you also take this medicine by mouth (in tablet or liquid form) for a short time before your first injection. Ask your doctor about any risk.Abilify Maintena is injected into a muscle. In this trial, 21.4% of these patients demonstrated ≥7% increase in body weight and 15.4% demonstrated a ≥7% decrease in body weight.Post-marketing case reports suggest that patients can experience intense urges, particularly for gambling, and the inability to control these urges while taking aripiprazole. In addition, all patients entering the trial must have experienced an acute psychotic episode as defined by both PANSS Total Score ≥80 and a PANSS score of >4 on each of four specific psychotic symptoms (conceptual disorganization, hallucinatory behavior, suspiciousness/persecution, unusual thought content) at screening and baseline. The primary endpoint was the change from baseline in PANSS total score to week 10.The inclusion criteria for this short-term trial included adult inpatients who met DSM-IV-TR criteria for schizophrenia. It should be noted that impulse-control symptoms can be associated with the underlying disorder. The Kaplan-Meier curves of the cumulative proportion of patients with relapse during the double-blind treatment phase for Abilify Maintena and placebo groups are shown in Figure 25.The key secondary efficacy endpoint, percentage of subjects meeting the relapse criteria, was statistically significantly lower in patients randomized to the Abilify Maintena group (10%) than in the placebo group (40%).The efficacy of Abilify Maintena for the maintenance treatment of bipolar I disorder was established in a 52-week, double-blind, placebo-controlled, randomized withdrawal trial in adult patients who were experiencing a manic episode at trial entry, met DSM-IV-TR criteria for bipolar I disorder, and had a history of at least one previous manic or mixed episode with manic symptoms of sufficient severity to require one of the following interventions: hospitalization and/or treatment with a mood stabilizer, and/or treatment with an antipsychotic agent.The primary efficacy endpoint was time from randomization to recurrence of any mood episode. Serum prolactin was not measured in the aripiprazole carcinogenicity studies. The mean intensity of injection pain reported by subjects using a visual analog scale (0=no pain to 100=unbearably painful) approximately one hour after injection was 7.1 (SD 14.5) for the first injection and 4.8 (SD 12.4) at the last visit in the double-blind, placebo-controlled phase.In an open-label study comparing bioavailability of Abilify Maintena administered in the deltoid or gluteal muscle, injection site pain was observed in both groups at approximately equal rates.In the short-term, placebo-controlled trial of Abilify Maintena in adults with schizophrenia, the incidence of reported EPS-related events, excluding events related to akathisia, for Abilify Maintena-treated patients was 9.6% vs. 5.2% for placebo. There are insufficient data with Abilify Maintena use in pregnant women to inform a drug-associated risk. Call your doctor for medical advice about side effects. You may need to continue taking oral this medicine for up to 3 weeks after your first injection.
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