Double-blind 18-month trial of lithium versus divalproex maintenance treatment in pediatric bipolar disorder.
OBJECTIVE
To determine whether divalproex sodium (DVPX) was superior to lithium carbonate (Li+) in the maintenance monotherapy treatment of youths diagnosed with bipolar disorder who had been previously stabilized on combination Li+ and DVPX (Li+/DVPX) pharmacotherapy.


METHODS
Youths ages 5-17 years with bipolar I or II disorder were initially treated with Li /DVPX. Patients meeting remission criteria for four consecutive weeks were then randomized in a double-blind fashion to treatment with either Li+ or DVPX for up to 76 weeks. Study participation ended if the subject required additional clinical intervention or if the subject did not adhere to study procedures.


RESULTS
Patients were recruited between July 1998 and May 2002. One hundred thirty-nine youths with a mean (SD) age of 10.8 (3.5) years were initially treated with Li+/DVPX for a mean (SD) duration of 10.7 (5.4) weeks. Sixty youths were then randomized to receive monotherapy with Li+ (n = 30) or DVPX (n = 30). The Li+ and DVPX treatment groups did not differ in survival time until emerging symptoms of relapse (p = .55) or survival time until discontinuation for any reason (p = .72).


CONCLUSIONS
DVPX was not found to be superior to Li+ as maintenance treatment in youths who stabilized on combination Li+/DVPX pharmacotherapy.
Findling
Robert L
RL
Department of Psychiatry, Case Western Reserve University, USA. robert.findling@uhhs.com
McNamara
Nora K
NK
Youngstrom
Eric A
EA
Stansbrey
Robert
R
Gracious
Barbara L
BL
Reed
Michael D
MD
Calabrese
Joseph R
JR
D000293:Adolescent; D000927:Anticonvulsants / Q000627:therapeutic use*; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D001714:Bipolar Disorder / Q000188:drug therapy*; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D016651:Lithium Carbonate / Q000627:therapeutic use*; D008297:Male; D014635:Valproic Acid / Q000627:therapeutic use*
D000927:Anticonvulsants; D014150:Antipsychotic Agents; D016651:Lithium Carbonate; D014635:Valproic Acid