Phase 3
N=379
Study of Outcome and Safety of Lithium, Divalproex and Risperidone for Mania in Children and Adolescents
Bipolar Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00057681 ↗Enrolled (actual)
379
Serious AEs
4.0%
Results posted
Mar 2013
Primary outcome: Primary: Clinical Global Impressions-Bipolar Mania Improvement — 2.49; 2.73; 1.70 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Lithium carbonate (Drug); Valproate (Drug); Risperidone (Drug)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Global Impressions-Bipolar Mania Improvement |
2.49; 2.73; 1.70 | — |
| SECONDARY Modified Side Effects Form for Children and Adolescents |
5.11; 4.95; 3.70 | — |
| SECONDARY K-SADS Mania Rating Scale |
24.06; 26.31; 14.58 | — |
Summary
This study will evaluate the effectiveness of the medications, lithium (Eskalith®), valproate (Depakote®), and risperidone (Risperdal®) in treating children and adolescents with bipolar disorder or symptoms of mania.
Eligibility Criteria
Inclusion Criteria
- DSM-IV criteria for bipolar I (manic or mixed) or mania for at least 4 weeks
- CGAS less than or equal to 60
- Good physical health
Exclusion Criteria
- Schizophrenia or any pervasive developmental disorder
- Major medical or neurological disease
- History of addiction to illicit substances or alcohol or drug abuse within the last 4 weeks
- IQ less than 70
- Pregnancy or breast-feeding
- Unacceptable methods of contraception
- In-patient care at baseline
Data sourced from ClinicalTrials.gov (NCT00057681). 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.