The Collaborative Lithium Trials (CoLT): specific aims, methods, and implementation
2008

Collaborative Lithium Trials: A Study on Lithium for Pediatric Bipolar Disorder

Sample size: 260 publication Evidence: high

Author Information

Author(s): Robert L Findling, Jean A Frazier, Vivian Kafantaris, Robert Kowatch, Jon McClellan, Mani Pavuluri, Linmarie Sikich, Stefanie Hlastala, Stephen R Hooper, Christine A Demeter, Denise Bedoya, Bernard Brownstein, Perdita Taylor-Zapata

Primary Institution: Department of Psychiatry, University Hospitals Case Medical Center/Case Western Reserve University

Hypothesis

Rational dosing strategies for lithium in children and adolescents will be able to be developed.

Conclusion

The studies will provide data to inform the labeling of lithium in children and adolescents with bipolar disorder and enhance clinical decision-making regarding its use.

Supporting Evidence

  • Lithium is a benchmark treatment for bipolar illness in adults.
  • Preliminary studies suggest lithium may be effective in treating children and adolescents with bipolar disorders.
  • Definitive randomized controlled trials of lithium have not been performed in pediatric populations.

Takeaway

This study is trying to find the best way to use lithium to help kids with bipolar disorder feel better and stay healthy.

Methodology

The study involves two multi-phase trials to establish dosing strategies, pharmacokinetics, efficacy, and safety of lithium in pediatric bipolar disorder.

Limitations

The data collected may not be applicable to all patients with bipolar I disorder due to specific inclusion and exclusion criteria.

Participant Demographics

Children and adolescents aged 7-17 years with bipolar I disorder experiencing manic or mixed episodes.

Digital Object Identifier (DOI)

10.1186/1753-2000-2-21

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