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Randomized double-blind placebo-controlled trial of lithium in youths with severe mood dysregulation.

Author(s): Dickstein DP, Towbin KE, Van Der Veen JW, Rich BA, Brotman MA, Knopf L, Onelio L, Pine DS, Leibenluft E

Affiliation(s): E.P. Bradley Hospital, Bradley-Hasbro Children's Research Center, 1 Hoppin ST Coro West, Providence, RI 02903, USA. Daniel_Dickstein@Brown.edu

Publication date & source: 2009-02, J Child Adolesc Psychopharmacol., 19(1):61-73.

Publication type: Randomized Controlled Trial; Research Support, N.I.H., Intramural

OBJECTIVE: The diagnosis and treatment of youth with severe nonepisodic irritability and hyperarousal, a syndrome defined as severe mood dysregulation (SMD) by Leibenluft, has been the focus of increasing concern. We conducted the first randomized double-blind, placebo-controlled trial in SMD youth, choosing lithium on the basis of its potential in treating irritability and aggression and neuro-metabolic effects. METHODS: SMD youths 7-17 years were tapered off their medications. Those who continued to meet SMD criteria after a 2-week, single-blind, placebo run-in were randomized to a 6-week double-blind trial of either lithium (n = 14) or placebo (n = 11). Clinical outcome measures were: (1) Clinical Global Impressions-Improvement (CGI-I) score less than 4 at trial's end and (2) the Positive and Negative Syndrome Scale (PANSS) factor 4 score. Magnetic resonance spectroscopy (MRS) outcome measures were myoinositol (mI), N-acetyl-aspartate (NAA), and combined glutamate/glutamine (GLX), all referenced to creatine (Cr). RESULTS: In all, 45% (n = 20/45) of SMD youths were not randomized due to significant clinical improvement during the placebo run-in. Among randomized patients, there were no significant between-group differences in either clinical or MRS outcome measures. CONCLUSION: Our study suggests that although lithium may not result in significant clinical or neurometabolic alterations in SMD youths, further SMD treatment trials are warranted given its prevalence.

Page last updated: 2009-10-20

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