Lamotrigine vs. lamotrigine plus divalproex in randomized, placebo-controlled maintenance treatment for bipolar depression.
OBJECTIVE
To compare the maintenance efficacy of lamotrigine (Lam) to combination therapy of Lam+divalproex ER (Div) in recently depressed patients with bipolar disorder (BD).


METHODS
We randomized 86 BD I or II patients in a major depressive episode to 8 months of double-blind treatment with Lam+placebo or Lam+Div. To be eligible for randomization, patients had to achieve control of both depressive and manic symptoms during an open phase that included both Lam and Div.


RESULTS
Time to depressive episode did not differ significantly by Kaplan-Maier survival analysis (χ2=1.82, df=1, P=0.18). However, several secondary outcomes did show significant differences. The proportion of Lam+placebo patients who had at least one Montgomery-Asberg Depression Rating Scale (MADRS) score≥15 during the maintenance phase was 67% (30/45) compared with 44% (18/41) for the Lam+Div group (χ2=4.51, P=0.03). Among BD I patients assigned to Lam+placebo, 71.4% (25/35) had at least one visit with MADRS score≥15 compared with 36.7% (11/30) among Lam+Div patients (χ2=7.89, df=1, P=0.005).


CONCLUSIONS
Lam+Div generally provided greater maintenance efficacy than Lam alone for depressive indices in recently depressed BD patients.
University of Texas Health Science Center, San Antonio, TX 78229-3900, USA. bowdenc@uthscsa.edu
C L
CL
Bowden
V
V
Singh
R
R
Weisler
P
P
Thompson
X
X
Chang
M
M
Quinones
J
J
Mintz
D000328:Adult; D018692:Antimanic Agents / Q000627:therapeutic use*; D001714:Bipolar Disorder / Q000188:drug therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D000077213:Lamotrigine; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D014227:Triazines / Q000627:therapeutic use*; D014635:Valproic Acid / Q000627:therapeutic use*
D018692:Antimanic Agents; D014227:Triazines; D014635:Valproic Acid; D000077213:Lamotrigine