@article{cda99db6c55440e0a2804a6d3365495b,
title = "A single blind comparison of lithium and lamotrigine for the treatment of bipolar II depression",
abstract = "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-D17), evaluated using mixed effects random regression. Results: Both groups showed significant improvement from baseline to endpoint on the Ham-D17 (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. Limitations: 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.",
keywords = "Bipolar Depression, Bipolar II Disorder, Lamotrigine, Lithium",
author = "Trisha Suppes and Marangell, {Lauren B.} and Bernstein, {Ira H.} and Kelly, {Dorothy I.} and Fischer, {E. Grace} and Zboyan, {Holly A.} and Snow, {Diane E.} and Melissa Martinez and {Al Jurdi}, Rayan and Geetha Shivakumar and Suresh Sureddi and Robert Gonzalez",
note = "Funding Information: We would like to thank Stanley Medical Research Institute, the National Institute of Mental Health, and GlaxoSmithKline for their support of this research. Funding Information: TS received research grants or research medications from Abbott Laboratories, AstraZeneca, GlaxoSmithKline, JDS Pharmaceuticals, Janssen Pharamceutica, the National Institute of Mental Health, Novartis Pharmaceuticals, Pfizer, Inc., the Stanley Medical Research Institute, and Wyeth; as of April 1, 2008, for the last 12 months she received no income from consulting agreements, advisory boards, speaking bureaus except for Orexigin Therapeutics Inc.; and receives royalties from Compact Clinicals. LBM received research grants and support from Bristol-Myers Squibb Company, Eli Lilly and Company, Cyberonics, Inc., Neuronetics, National Institute of Mental Health, Stanley Foundation, NARSAD, American Foundation for Suicide Prevention, Aspect Medical Systems, and Sanofi Aventis; and she has had consulting agreements or received honoraria from Eli Lilly and Company, GlaxoSmithKline, Cyberonics, Inc., Pfizer, Medronics, Forest, Aspect Medical Systems, Novartis, and Sepracor. DES has had a consulting agreement with Paroxel; has received honoraria from Pfizer Inc and Eli Lilly; and has served on the speaking bureaus for AstraZeneca and Bristol Meyers Squibb. MM received grant and research support from Cyberonics, Inc., Eli Lilly and Company, Sanofi-Aventis, Aspect Medical Systems, Bristol-Meyers Squibb, Neuronetics, and the National Institute of Mental Health. SS has served on the speaking bureau for GlaxoSmithKline. GS is a Clinical Research Scholar Training Program supported by Grant Number UL1RR024982, titled, “North and Central Texas Clinical and Translational Science Initiative” (Milton Packer, M.D., PI) from the National Center for Research Resources (NCRR), a component of the National Institutes of Health (NIH) and NIH Roadmap for Medical Research, and its contents are solely the responsibility of the authors and do not necessarily represent the official view of the NCRR or NIH. Information on NCRR is available at http://www.ncrr.nih.gov/ . Information on Re-engineering the Clinical Research Enterprise can be obtained from http://nihroadmap.nih.gov/clinicalresearch/overview-translational.asp . All other authors declare that they have no conflicts of interest. Funding Information: Funding for this study was provided by NIMH Grant 1 R21 MH067055-01A1 and by Stanley Medical Research Institute Grant 02T-158. The NIMH and Stanley Medical Research Institute had no further role in study design; in the collection, analysis and interpretation of data; in the writing of the report; and in the decision to submit the paper for publication. GlaxoSmithKline provided medication for this study and had no further role in study design or in the collection, analysis and interpretation of the data. GlaxoSmithKline was provided the opportunity to review this paper prior to submission and to provide editorial feedback. ",
year = "2008",
month = dec,
doi = "10.1016/j.jad.2008.02.004",
language = "English (US)",
volume = "111",
pages = "334--343",
journal = "Journal of affective disorders",
issn = "0165-0327",
publisher = "Elsevier",
number = "2-3",
}