However, the authors note, “Even though aripiprazole maintenance was statistically superior to placebo maintenance, alone it was not sufficient to keep most youth stable for extended periods of time.”
Dr. Robert L. Findling, with University Hospitals, Case Medical Center in Cleveland, Ohio, and colleagues point out that the validity and seriousness of bipolar disorder in children under 10 years of age has been documented by a growing amount of research. Safe and effective long-term interventions are needed.
The team first treated 96 children aged 4 to 9 years with a bipolar disorder for 16 weeks with aripiprazole. Then, 60 of the children (mean age 6.7 years) with an a priori response were randomly assigned to have their aripiprazole tapered and replaced with a placebo or to continue on the medication for 72 weeks
The current study reports on the outcomes of that maintenance phase, in which the primary outcome was time to discontinuation because of a mood event. The median time in the aripiprazole group was 6.14 weeks, significantly longer than in the placebo group, 2.29 weeks (p=0.005), according to the report.
Median time to discontinuation for any reason was 4.00 weeks in the aripiprazole arm versus 2.00 weeks in the placebo arm (p=0.003), Dr. Findling and colleagues found.
“Notably,” they point out, “only 6 of the original 30 patients randomly assigned to treatment with aripiprazole completed 72 weeks of double-blind treatment.”
However, from a safety standpoint, no patient discontinued because of adverse events. In terms of tolerance, children assigned to aripiprazole were more likely than those given placebo to complain of stomach pain (33% vs 3%) and musculoskeletal pain (27% vs 13%).
Overall, the authors conclude, “These findings underscore the crucial need for studies that extend beyond acute stabilization and evaluate effectiveness and maintenance over longer terms.”
J Clin Psychiatry 2011.