CompletedPhase 3

Lithium Versus Divalproex for Treating Pediatric Bipolar Disorder

United States153 participantsStarted 2001-03

Plain-language summary

This study compared the efficacy of lithium, divalproex, and placebo in treating the acute phase of symptomatic bipolar I disorder, mixed or manic episode, in children and adolescents.

Who can participate

Age range7 Years – 18 Years

SexALL

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Inclusion criteria

✓. 7.0 - 17 years of age
✓. Bipolar I Disorder, mixed or manic episode, psychotic or non-psychotic, according to DSM IV criteria
✓. Score of \> 14 on the Y-MRS
✓. Normal intelligence
✓. Ability and willingness to provide assent and informed, written consent from at least one parent or legal guardian
✓. No current general medical illnesses requiring medication

What they're measuring

Young Mania Rating Scale (YMRS) & Clinical Global Impressions I (CGI-I)

Timeframe: 8 weeks

Trial details

NCT IDNCT00221429

SponsorChildren's Hospital Medical Center, Cincinnati

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2006-08

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