Article

Lamotrigine adjunctive therapy to lithium and divalproex in depressed patients with rapid cycling bipolar disorder and a recent substance use disorder: a 12-week, double-blind, placebo-controlled pilot study.

Department of Psychiatry, Case Western Reserve University School of Medicine, Cleveland, OH, USA.
Psychopharmacology bulletin (impact factor: 1.35). 01/2010; 43(4):5-21. pp.5-21
Source: PubMed

ABSTRACT To pilot the efficacy and safety data of lamotrigine adjunctive therapy to lithium and divalproex in patients with rapid-cycling bipolar disorder (RCBD) and a recent substance use disorder (SUD).
Structured clinical interviews were used to ascertain DSM-IV diagnosis of RCBD, SUDs, and other Axis I disorders. Patients who did not meet the criteria for a bimodal response after up to 16-weeks of open-label treatment with lithium plus divalproex, as measured by MADRS (Montgomery-Asberg Depression Rating Scale) ≤ 19, YMRS ( Young Mania Rating Scale) ≤ 12 and GAF (Global Assessment of Functioning) = 51 for 4 weeks, were randomized to a 12- week, double-blind addition of lamotrigine or placebo to lithium plus divalproex. Primary and secondary outcomes were analyzed with ANCOVA, t-test, or chi-square/Fisher's exact.
Of 98 patients enrolled into the study, 36 were randomized to receive lamotrigine (n = 18) or placebo (n ± 18), and 8 patients per arm completed the study. No patient discontinued due to adverse events. The change in MADRS total score from baseline to endpoint was -9.1 ± 11.2 in lamotrigine-treated patients versus -4.5 ± 13.1 in placebo-treated patients (p = 0.27). There were no significant differences in changes in YMRS total scores and rates of response or remission.
Lamotrigine adjunctive therapy was well tolerated in patients previously non-responsive to initial treatment of lithium plus divalproex. A larger study is warranted to determine the efficacy and safety of adjunctive lamotrigine versus placebo in RCBD with a recent SUD.

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Keywords

8 patients
 
98 patients
 
adjunctive lamotrigine
 
adverse events
 
bimodal response
 
chi-square/Fisher's exact
 
DSM-IV diagnosis
 
Global Assessment
 
initial treatment
 
lamotrigine adjunctive therapy
 
lamotrigine-treated patients
 
MADRS total score
 
Montgomery-Asberg Depression Rating Scale
 
open-label treatment
 
placebo-treated patients
 
rapid-cycling bipolar disorder
 
recent substance use disorder
 
Structured clinical interviews
 
YMRS total scores
 
Young Mania Rating Scale