Side Effect Study of Antipsychotic Medicines to Treat Childhood Bipolar Disorder

Summary

The purpose of this study is to learn more about weight gain and related side effects when children are treated with antipsychotic medicine for mood disorders.

Timeline

Start

2008-06

Primary completion

2010-10

Completion

2010-10

Outcome

Missed primary endpoint

Stopped (Business): “Due low rate of participation and lack of funding”

registry MEAN Risperidone: 8.5 (Standard Deviation NA) pounds MEAN Aripiprazole: 6.65 (Standard Deviation 1.48) pounds NCT00746252 ↗

registry analysis (other test); Risperidone vs Aripiprazole; p = .495; t-test, 2 sided; note: Threshold of significance is p\<.05 NCT00746252 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aripiprazole	Other / unclassified	—	—
Subject	Risperidone	Other / unclassified	—	—

Indications