CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 379 enrolled
Drug / intervention
Lithium carbonate +2 moredrug
Likely dose
Lithium carbonate titrated to blood level 1.1–1.3 mEq/L; Valproate titrated to blood level 111–125 µg/mL; Risperidone 2.0–3.0 mg BID (weight-based titration)AI-extracted
Key inclusion· 3
  • ✓DSM-IV criteria for bipolar I disorder in manic or mixed episode lasting at least 4 weeks
  • ✓Children with significantly impaired functioning (CGAS score ≤60)
  • ✓Good physical health at baseline
Key exclusion· 6
  • ✕Schizophrenia or pervasive developmental disorders (autism spectrum, etc.)
  • ✕Major medical or neurological disease
  • ✕History of substance abuse or addiction within the past 4 weeks
  • ✕Intelligence quotient (IQ) less than 70

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00057681
NCT00057681Phase 3Completed
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Treatment of Early Age Mania (TEAM) Study

Washington University School of Medicine·interventional·Posted Apr 7, 2003·Updated Apr 4, 2013

In Brief

A Phase 3 clinical trial evaluating Lithium carbonate, Valproate, and 1 other intervention for Bipolar Disorder. Completed, enrolled 379 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH)

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 7, 2003
Enrollment StartFeb 1, 2003
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 23.2 years ago

Interventions

Lithium carbonatedrug

Titrated until blood level is 1.1 to 1.3 mEq/L

Valproatedrug

Titrated until blood level is 111 to 125 ug/mL

Risperidonedrug

Titrated by weight until dose is 2.0 mg BID to 3.0 mg BID