Effect Size of Lithium, Divalproex Sodium, and Carbamazepine in Children and Adolescents With Bipolar Disorder
Accepted 14 December 1999.
ABSTRACT
Objective
To develop effect sizes for 3 mood stabilizers-lithium, divalproex sodium, and carbamazepine-for the acute-phase treatment of bipolar I or II disorder, mixed or manic episode, in children and adolescents aged 8 to 18 years.
Method
Forty-two outpatients with a mean age of 11.4 years (20 with bipolar I disorder and 22 with bipolar II disorder) were randomly assigned to 6 weeks of open treatment with either lithium, divalproex sodium, or carbamazepine. The primary efficacy measures were the weekly Clinical Global Impression Improvement scores and the Young Mania Rating Scale (Y-MRS).
Results
Using a ≥50% change from baseline to exit in the Y-MRS scores to define response, the effect size was 1.63 for divalproex sodium, 1.06 for lithium, and 1.00 for carbamazepine. Using this same response measure with the intent-to-treat sample, the response rates were as follows: sodium divalproex, 53%; lithium, 38%; and carbamazepine, 38% (χ22 = 0.85, p = .60). All 3 mood stabilizers were well tolerated, and no serious adverse effects were seen.
Conclusions
Divalproex sodium, lithium, and carbamazepine all showed a large effect size in the open treatment of children and adolescents with bipolar I or II disorder in a mixed or manic episode.
From the Departments of Psychiatry, Neurology, and Biostatistics, The University of Texas Southwestern Medical Center at Dallas and Children's Medical Center of Dallas
Reprint requests to Dr. Kowatch, University of Texas Southwestern Medical Center at Dallas, Department of Psychiatry, 5323 Harry Hines Blvd., Dallas, TX 75235-9070
The authors gratefully acknowledge support from the NAMI/Stanley Foundation Research Awards Program and NIMH grants K07-MH01057 (Dr. Kowatch) and MH53799 (Dr. Rush). Dr. Weinberg was funded by The Caleb C. and Julia W. Dula Education and Charitable Foundations, Mr. and Mrs. Woody Hunt, Mr. and Mrs. Morton Myerson, and the Azoulay family. The authors acknowledge the administrative support of Kenneth Z. Altshuler, M.D., Stanton Sharp Distinguished Chair, Professor and Chairman, Department of Psychiatry.
ABSTRACT