Lithium treatment of acute mania in adolescents: a placebo-controlled discontinuation study.
OBJECTIVE
There are no published placebo-controlled studies of any agent in the treatment of acute mania in children or adolescents. This is the first placebo-controlled study of lithium's efficacy in the treatment of acute mania in adolescents.


METHODS
In this discontinuation study, participants received open treatment with lithium at therapeutic serum levels (mean 0.99 mEq/L) for at least 4 weeks. Responders were randomly assigned to continue or discontinue lithium during a 2-week double-blind, placebo-controlled phase. This study had 80% power to detect a 40% difference in exacerbation rates between groups (10% on lithium versus 50% on placebo).


RESULTS
Twenty-three of 40 protocol participants (57.5%) experienced a clinically significant symptom exacerbation during the 2-week double-blind phase. However, the slightly lower exacerbation rate in the group maintained on lithium (10/19 or 52.6%) versus the group switched to placebo (13/21 or 61.9%) did not reach statistical significance.


CONCLUSIONS
This study does not support a large effect for lithium continuation treatment of adolescents with acute mania, mostly due to the unexpectedly high rate of exacerbations in the group that continued on lithium. Further studies are warranted to clarify whether acute mania in adolescents is lithium responsive.
Kafantaris
Vivian
V
Department of Psychiatry, The Zucker Hillside Hospital, Glen Oaks, NY 11004, USA. kafantar@lij.edu
Coletti
Daniel J
DJ
Dicker
Robert
R
Padula
Gina
G
Pleak
Richard R
RR
Alvir
Jose Maria J
JM
D000208:Acute Disease; D000293:Adolescent; D000374:Aggression / Q000187:drug effects; D018692:Antimanic Agents / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use; D001714:Bipolar Disorder / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy*; D010054:Brief Psychiatric Rating Scale; D015897:Comorbidity; D018450:Disease Progression; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D018021:Lithium Chloride / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D008297:Male; D011618:Psychotic Disorders / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy; D012008:Recurrence; D018967:Risperidone / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use; D016896:Treatment Outcome
D018692:Antimanic Agents; D014150:Antipsychotic Agents; D018021:Lithium Chloride; D018967:Risperidone