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

Zuowei Wang, Keming Gao, David E. Kemp, Philip K. Chan, Mary Beth Serrano, Carla Conroy, Yiru Fang, Stephen J. Ganocy, Robert L. Findling, Joseph R. Calabrese

Research output: Contribution to journalArticlepeer-review

Abstract

Objective: 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). Method: 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. Results: 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. Conclusions: 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.

Original languageEnglish (US)
Pages (from-to)1-17
Number of pages17
JournalPsychopharmacology bulletin
Volume44
Issue number4
StatePublished - Dec 31 2011

Keywords

  • Bipolar disorder
  • Lamotrigine
  • Mood stabilizer
  • Placebo-controlled trial
  • Substance use disorder
  • Treatment-refractory

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Pharmacology (medical)

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