Phase 3
Completed N=65
Risperidone and Divalproex Sodium With MRI Assessment in Pediatric Bipolar
Source: ClinicalTrials.gov NCT00176202 ↗Enrolled (actual)
65
Serious AEs
0.0%
Results posted
Nov 2015
Primary outcomePrimary: Young Mania Rating Scale (YMRS) — 25.09; 30.59; 15.24; 10.22 units on a scale — p=<0.01
Summary
The study is to examine the null hypothesis that risperidone and divalproex sodium are equally effective in treating/stabilizing pediatric bipolar disorder.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Young Mania Rating Scale (YMRS) |
25.09; 30.59; 15.24; 10.22 | <0.01 sig |
| SECONDARY Child Depression Rating Scale- Revised (CDRS-R) |
40.76; 41.72; 35.76; 25.88 | <.01 sig |
| SECONDARY Child Mania Rating Scale (CMRS) |
30.84; 28.0; 16.35; 19.20 | <0.01 sig |
| SECONDARY Clinical Global Improvement in Bipolar Disorder Overall (CGI-BP Overall) |
4.80; 4.37; 2.77; 2.97 | <0.01 sig |
Eligibility Criteria
Inclusion Criteria
- Children with Bipolar Disorder
- Must be able to swallow tablets
Exclusion Criteria
- Children with general medical condition such as head injury, epilepsy, endocrine disorders
- Those who are on mood altering medications such as steroids, and those diagnosed with mental retardation are excluded to avoid confounding and contributing factors to mood swings.
- If we discover during the interview that the parent and/or child does not understand the consent/assent procedures, we will exclude them.
We expect only a small number of children to be excluded from the study due to exclusionary criteria. Selection of the subjects is not based on sex, race, or ethnic group.
Data sourced from ClinicalTrials.gov (NCT00176202). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.