A single blind comparison of lithium and lamotrigine for the treatment of bipolar II depression.
BACKGROUND
Treatment studies are lacking for patients with bipolar II disorder (BDII). The objective of this study was to compare lamotrigine (LTG) and lithium (Li) monotherapy for the treatment of BDII depression.


METHODS
Patients with BDII acute depression were randomized to open-label monotherapy with LTG or Li, and evaluated by trained raters blinded to treatment. Patients were titrated to 200 mg/day of LTG over 8 weeks or at least 900 mg/day of Li over 2 weeks (serum level 0.6-1.2 mEq/L), and seen biweekly for 16 weeks. The primary outcome variable was change in the Hamilton Depression Rating Scale 17-item (Ham-D(17)), evaluated using mixed effects random regression.


RESULTS
Both groups showed significant improvement from baseline to endpoint on the Ham-D(17) (p<0.0001), with no between group differences (p=0.95). Seventy-two percent of the population was rapid cycling by DSM-IV criteria. No differences in response were noted between rapid cyclers and non-rapid cyclers. Early termination for any cause was 42%. The Li group reported significantly more side effects, although drop-out due to side effects did not differ between groups.


CONCLUSIONS
This study was limited by an open treatment design, a lack of placebo arm, and uneven treatment groups.


CONCLUSIONS
Lamotrigine and lithium were effective monotherapy for BDII depression, with comparable response and remission rates. Naturalistic design and lack of placebo limit conclusions, though patient history indicated long standing depression unlikely to be alleviated by time. Patients who received Li reported more side effects, but this did not appear to impact drop-out rates.
Suppes
Trisha
T
Bipolar Disorders Research Program, Department of Psychiatry, University of Texas Southwestern Medical Center at Dallas, Dallas, Texas 75390-9121, United States. trisha.suppes@utsouthwestern.edu
Marangell
Lauren B
LB
Bernstein
Ira H
IH
Kelly
Dorothy I
DI
Fischer
E Grace
EG
Zboyan
Holly A
HA
Snow
Diane E
DE
Martinez
Melissa
M
Al Jurdi
Rayan
R
Shivakumar
Geetha
G
Sureddi
Suresh
S
Gonzalez
Robert
R
D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D000368:Aged; D000553:Ambulatory Care; D000927:Anticonvulsants / Q000009:adverse effects / Q000627:therapeutic use*; D001714:Bipolar Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D039721:Diagnostic and Statistical Manual of Mental Disorders; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D000077213:Lamotrigine; D018020:Lithium Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010352:Patient Dropouts; D011569:Psychiatric Status Rating Scales; D012720:Severity of Illness Index; D016037:Single-Blind Method; D016019:Survival Analysis; D016896:Treatment Outcome; D014227:Triazines / Q000009:adverse effects / Q000627:therapeutic use*
D000927:Anticonvulsants; D018020:Lithium Compounds; D014227:Triazines; D000077213:Lamotrigine