Tuesday, May 19, 2009

Bipolar Disorder: Divalproex ER vs Placebo

Just before I retired, it has become fashionable to use anticonvulsants as a mood stabiliser. Being a traditionalist, I felt then that the evidence was not clear and I tended to stick with the trusted lithium.

Well my doubts were confirmed:

Journal of the American Academy of Child & Adolescent Psychiatry:
May 2009 - Volume 48 - Issue 5 - pp 519-532
doi: 10.1097/CHI.0b013e31819c55ec
New Research


A Double-Blind, Randomized, Placebo-Controlled Trial of Divalproex Extended-Release in the Treatment of Bipolar Disorder in Children and Adolescents
WAGNER, KAREN DINEEN M.D. et al.

Abstract
Objective: To compare the efficacy and safety of divalproex extended-release (ER) to placebo in a 28-day double-blind study of bipolar disorder in children and adolescents and evaluate the safety of divalproex ER in a 6-month open-label extension study.
Method: In the double-blind study, 150 patients (manic or mixed episode, aged 10-17 years) with baseline Young Mania Rating Scale (YMRS) score of 20 or higher were randomized to once-daily placebo or divalproex ER, which was titrated to clinical response or serum valproate concentration of 80 to 125 μg/mL. Sixty-six patients enrolled in the extension study.
Results: In the double-blind study, a treatment effect was not observed with divalproex ER based on change in mean YMRS score (divalproex ER -8.8 [n = 74]; placebo -7.9 [n = 70]) or secondary measures. Divalproex was similar to placebo based on incidence of adverse events. Four subjects treated with divalproex ER and three treated with placebo discontinued because of adverse events. Mean ammonia levels increased in the divalproex ER group, but only one patient was symptomatic. In the long-term study, YMRS scores decreased modestly (2.2 points from baseline). The most common adverse events were headache and vomiting.
Conclusions: The results of the study do not provide support for the use of divalproex ER in the treatment of youths with bipolar I disorder, mixed or manic state. Further controlled trials are required to confirm or refute the findings from this study. J. Am. Acad. Child Adolesc. Psychiatry, 2009;48(5):519-532.

An earlier Harvard study showed that Lithium reduced suicide risks by as much as 9 fold.


Related Posts:


Bipolar Disorder: Lithium-The Aspirin of Psychiatry?
Lithium Bipolar and Nanking
Bipolar Disorder in Children
Bipolar and ADHD: Boys and Breasts
Statins-Harvard-Roosevelt
Bipolar Disorder: Biederman Einstein God.
Antipsychotics: Really?

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