A randomized, double-blind, placebo-controlled, study of the efficacy and safety of aripiprazole 10, 15 or 20mg/day for the treatment of patients with acute exacerbations of schizophrenia

Jul 17, 2007Journal of psychiatric research

Aripiprazole’s safety and effectiveness at 10, 15, or 20 mg/day for treating sudden worsening of schizophrenia

AI simplified

Psychedelic Science on OpenScience ↗PubMed ↗DOI ↗

Abstract

In a double-blind study of 420 patients, aripiprazole 10, 15, and 20 mg/day showed significantly greater improvements in symptoms of schizophrenia compared to placebo.

Improvements in the Positive and Negative Syndrome Scale (PANSS) Total score were observed as early as Week 1 for doses of 10 and 20 mg/day, and by Week 3 for 15 mg/day.
Of the initial 420 patients, 142 (34%) completed the 6-week treatment period, while 131 (31%) transitioned to open-label aripiprazole due to lack of improvement.
All three doses of aripiprazole demonstrated significant efficacy in reducing symptoms compared to placebo across multiple measures.
No clinically meaningful differences were found in extrapyramidal symptoms, prolactin levels, or weight changes when compared to placebo.
Aripiprazole 10 mg/day is both effective and well tolerated for patients experiencing acute exacerbations of schizophrenia.

AI simplified

This double-blind, multicenter study aimed to investigate the efficacy and safety of aripiprazole 10, 15 or 20 mg/day versus placebo. Patients requiring inpatient hospitalization for acute exacerbation of schizophrenia were randomized to once-daily aripiprazole 10, 15 or 20 mg/day or placebo for 6 weeks. The primary efficacy outcome was the mean change from baseline to Week 6 in the Positive and Negative Syndrome Scale (PANSS) Total score (last observation carried forward). Patients with no improvement by Week 3 (Clinical Global Impression-Global Improvement score > or =4) could transfer to open-label aripiprazole 20mg/day. In total, 420 patients were randomized to placebo (n = 108); aripiprazole 10 mg/day (n = 106); 15 mg/day (n = 106); or 20 mg/day (n = 100). Of these, 142 patients (34%) completed 6 weeks of treatment, 131 (31%) discontinued to receive open-label aripiprazole, and 147 (35%) for other reasons. Aripiprazole 10, 15 and 20 mg/day each showed significantly greater improvements from baseline than placebo for all efficacy measures, including PANSS Total, Positive and Negative scores, and the CGI-Severity of Illness score. Significantly greater improvements in PANSS Total score versus placebo were achieved by Week 1 with 10 or 20 mg/day and Week 3 with 15 mg/day. All three doses were well tolerated. Overall, aripiprazole was not associated with clinically meaningful differences in extrapyramidal symptoms, prolactin or weight changes versus placebo. Aripiprazole 10 mg/day is effective and well tolerated for patients experiencing an acute exacerbation of schizophrenia.

Full Text

Full text is available at the source.

View full text (XML) ↗View full text ↗

A randomized, double-blind, placebo-controlled, study of the efficacy and safety of aripiprazole 10, 15 or 20mg/day for the treatment of patients with acute exacerbations of schizophrenia

Abstract

Full Text

You found one interesting study. We’ll send the next 7.

what lands in your inbox each week:

Recent issues from the psychedelic science brief

Abstract

Full Text

Related papers

You found one interesting study. We’ll send the next 7.

what lands in your inbox each week:

Recent issues from the psychedelic science brief