Effect size of lithium, divalproex sodium, and carbamazepine in children and adolescents with bipolar disorder.
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.


METHODS
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 > or = 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% (chi 2(2) = 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.
Kowatch
R A
RA
Department of Psychiatry, University of Texas Southwestern Medical Center at Dallas 75235-9070, USA. kowatch@utsw.swmed.edu
Suppes
T
T
Carmody
T J
TJ
Bucci
J P
JP
Hume
J H
JH
Kromelis
M
M
Emslie
G J
GJ
Weinberg
W A
WA
Rush
A J
AJ
D000208:Acute Disease; D000293:Adolescent; D000367:Age Factors; D018692:Antimanic Agents / Q000494:pharmacology / Q000627:therapeutic use*; D001714:Bipolar Disorder / Q000188:drug therapy*; D002220:Carbamazepine / Q000494:pharmacology / Q000627:therapeutic use*; D002648:Child; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008094:Lithium / Q000494:pharmacology / Q000627:therapeutic use*; D008297:Male; D010045:Outpatients / Q000706:statistics & numerical data; D010865:Pilot Projects; D011569:Psychiatric Status Rating Scales; D014635:Valproic Acid / Q000494:pharmacology / Q000627:therapeutic use*
D018692:Antimanic Agents; D002220:Carbamazepine; D014635:Valproic Acid; D008094:Lithium