TY - JOUR
T1 - A placebo-controlled study of lamotrigine and gabapentin monotherapy in refractory mood disorders
AU - Frye, Mark A.
AU - Ketter, Terence A.
AU - Kimbrell, Timothy A.
AU - Dunn, Robert T.
AU - Speer, Andrew M.
AU - Osuch, Elizabeth A.
AU - Luckenbaugh, David A.
AU - Corá-Locatelli, Gabriela
AU - Leverich, Gabriele S.
AU - Post, Robert M.
N1 - Copyright:
Copyright 2010 Elsevier B.V., All rights reserved.
PY - 2000
Y1 - 2000
N2 - There is a pressing need for additional treatment options for refractory mood disorders. This controlled comparative study evaluated the efficacy of lamotrigine (LTG) and gabapentin (GBP) monotherapy versus placebo (PLC). Thirty-one patients with refractory bipolar and unipolar mood disorders participated in a double-blind, randomized, crossover series of three 6-week monotherapy evaluations including LTG, GBP, and PLC. There was a standardized blinded titration to assess clinical efficacy or to determine the maximum tolerated daily dose (LTG 500 mg or GBP 4,800 mg). The primary outcome measure was the Clinical Global Impressions Scale (CGI) for Bipolar Illness as supplemented by other standard rating instruments. The mean doses at week 6 were 274 ± 128 mg for LTG and 3,987 ± 856 mg for GBP. Response rates (CGI ratings of much or very much improved) were the following: LTG, 52% (16/31); GBP, 26% (8/31); and PLC, 23% (7/31) (Cochran's Q = 6.952, df = 2, N = 31, p = 0.031). Post hoc Q differences (df = 1, N = 31) were the following: LTG versus GBP (Q(diff) = 5.33, p = 0.011); LTG versus PLC (Q(diff) = 4.76, p = 0.022); and GBP versus PLC (Q(diff) = 0.08, p = 0.70). With respect to anticonvulsant dose and gender, there was no difference between the responders and the nonresponders. The agents were generally well tolerated. This controlled investigation preliminarily suggests the efficacy of LTG in treatment-refractory affectively ill patients. Further definition of responsive subtypes and the role of these medications in the treatment of mood disorders requires additional study.
AB - There is a pressing need for additional treatment options for refractory mood disorders. This controlled comparative study evaluated the efficacy of lamotrigine (LTG) and gabapentin (GBP) monotherapy versus placebo (PLC). Thirty-one patients with refractory bipolar and unipolar mood disorders participated in a double-blind, randomized, crossover series of three 6-week monotherapy evaluations including LTG, GBP, and PLC. There was a standardized blinded titration to assess clinical efficacy or to determine the maximum tolerated daily dose (LTG 500 mg or GBP 4,800 mg). The primary outcome measure was the Clinical Global Impressions Scale (CGI) for Bipolar Illness as supplemented by other standard rating instruments. The mean doses at week 6 were 274 ± 128 mg for LTG and 3,987 ± 856 mg for GBP. Response rates (CGI ratings of much or very much improved) were the following: LTG, 52% (16/31); GBP, 26% (8/31); and PLC, 23% (7/31) (Cochran's Q = 6.952, df = 2, N = 31, p = 0.031). Post hoc Q differences (df = 1, N = 31) were the following: LTG versus GBP (Q(diff) = 5.33, p = 0.011); LTG versus PLC (Q(diff) = 4.76, p = 0.022); and GBP versus PLC (Q(diff) = 0.08, p = 0.70). With respect to anticonvulsant dose and gender, there was no difference between the responders and the nonresponders. The agents were generally well tolerated. This controlled investigation preliminarily suggests the efficacy of LTG in treatment-refractory affectively ill patients. Further definition of responsive subtypes and the role of these medications in the treatment of mood disorders requires additional study.
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U2 - 10.1097/00004714-200012000-00004
DO - 10.1097/00004714-200012000-00004
M3 - Article
C2 - 11106131
AN - SCOPUS:0033697737
SN - 0271-0749
VL - 20
SP - 607
EP - 614
JO - Journal of Clinical Psychopharmacology
JF - Journal of Clinical Psychopharmacology
IS - 6
ER -