title: Switch Rates During Acute Treatment for Bipolar II Depression With Lithium, Sertraline, or the Two Combined: A Randomized Double-Blind Comparison.
abstract: OBJECTIVE
  The authors compared medication-induced mood switch risk (primary outcome), as well as treatment response and side effects (secondary outcomes) with three acute-phase treatments for bipolar II depression.
  
  
  METHODS
  In a 16-week, double-blind, multisite comparison study, 142 participants with bipolar II depression were randomly assigned to receive lithium monotherapy (N=49), sertraline monotherapy (N=45), or combination treatment with lithium and sertraline (N=48). At each visit, mood was assessed using standardized rating scales. Rates of switch were compared, as were rates of treatment response and the presence and severity of treatment-emergent side effects.
  
  
  RESULTS
  Twenty participants (14%) experienced a switch during the study period (hypomania, N=17; severe hypomania, N=3). Switch rates did not differ among the three treatment groups, even after accounting for dropout. No patient had a manic switch or was hospitalized for a switch. Most switches occurred within the first 5 weeks of treatment. The treatment response rate for the overall sample was 62.7% (N=89), without significant differences between groups after accounting for dropout. The lithium/sertraline combination group had a significantly higher overall dropout rate than the monotherapy groups but did not have an accelerated time to response.
  
  
  CONCLUSIONS
  Lithium monotherapy, sertraline monotherapy, and lithium/sertraline combination therapy were associated with similar switch and treatment response rates in participants with bipolar II depression. The dropout rate was higher in the lithium/sertraline combination treatment group, without any treatment acceleration advantage.
authors.affiliation: From the Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA, Los Angeles; the Jane and Terry Semel Institute of Neuroscience and Human Behavior, University of California, Los Angeles; the Department of Psychiatry, VA Greater Los Angeles Healthcare System, West Los Angeles Healthcare Center, Los Angeles; the Department of Biostatistics, School of Public Health, University of California, Los Angeles; the Lindner Center of HOPE, Mason, Ohio; the Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati; the Department of Psychiatry and Biobehavioral Sciences, Stanford University School of Medicine, Stanford, Calif.; the VA Palo Alto Health Care System, Palo Alto, Calif.; and the Department of Psychiatry, Olive View-UCLA Medical Center, Sylmar, Calif.
authors.forename: Lori L
authors.initials: LL
authors.lastname: Altshuler
authors.affiliation: From the Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA, Los Angeles; the Jane and Terry Semel Institute of Neuroscience and Human Behavior, University of California, Los Angeles; the Department of Psychiatry, VA Greater Los Angeles Healthcare System, West Los Angeles Healthcare Center, Los Angeles; the Department of Biostatistics, School of Public Health, University of California, Los Angeles; the Lindner Center of HOPE, Mason, Ohio; the Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati; the Department of Psychiatry and Biobehavioral Sciences, Stanford University School of Medicine, Stanford, Calif.; the VA Palo Alto Health Care System, Palo Alto, Calif.; and the Department of Psychiatry, Olive View-UCLA Medical Center, Sylmar, Calif.
authors.forename: Catherine A
authors.initials: CA
authors.lastname: Sugar
authors.affiliation: From the Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA, Los Angeles; the Jane and Terry Semel Institute of Neuroscience and Human Behavior, University of California, Los Angeles; the Department of Psychiatry, VA Greater Los Angeles Healthcare System, West Los Angeles Healthcare Center, Los Angeles; the Department of Biostatistics, School of Public Health, University of California, Los Angeles; the Lindner Center of HOPE, Mason, Ohio; the Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati; the Department of Psychiatry and Biobehavioral Sciences, Stanford University School of Medicine, Stanford, Calif.; the VA Palo Alto Health Care System, Palo Alto, Calif.; and the Department of Psychiatry, Olive View-UCLA Medical Center, Sylmar, Calif.
authors.forename: Susan L
authors.initials: SL
authors.lastname: McElroy
authors.affiliation: From the Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA, Los Angeles; the Jane and Terry Semel Institute of Neuroscience and Human Behavior, University of California, Los Angeles; the Department of Psychiatry, VA Greater Los Angeles Healthcare System, West Los Angeles Healthcare Center, Los Angeles; the Department of Biostatistics, School of Public Health, University of California, Los Angeles; the Lindner Center of HOPE, Mason, Ohio; the Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati; the Department of Psychiatry and Biobehavioral Sciences, Stanford University School of Medicine, Stanford, Calif.; the VA Palo Alto Health Care System, Palo Alto, Calif.; and the Department of Psychiatry, Olive View-UCLA Medical Center, Sylmar, Calif.
authors.forename: Brian
authors.initials: B
authors.lastname: Calimlim
authors.affiliation: From the Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA, Los Angeles; the Jane and Terry Semel Institute of Neuroscience and Human Behavior, University of California, Los Angeles; the Department of Psychiatry, VA Greater Los Angeles Healthcare System, West Los Angeles Healthcare Center, Los Angeles; the Department of Biostatistics, School of Public Health, University of California, Los Angeles; the Lindner Center of HOPE, Mason, Ohio; the Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati; the Department of Psychiatry and Biobehavioral Sciences, Stanford University School of Medicine, Stanford, Calif.; the VA Palo Alto Health Care System, Palo Alto, Calif.; and the Department of Psychiatry, Olive View-UCLA Medical Center, Sylmar, Calif.
authors.forename: Michael
authors.initials: M
authors.lastname: Gitlin
authors.affiliation: From the Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA, Los Angeles; the Jane and Terry Semel Institute of Neuroscience and Human Behavior, University of California, Los Angeles; the Department of Psychiatry, VA Greater Los Angeles Healthcare System, West Los Angeles Healthcare Center, Los Angeles; the Department of Biostatistics, School of Public Health, University of California, Los Angeles; the Lindner Center of HOPE, Mason, Ohio; the Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati; the Department of Psychiatry and Biobehavioral Sciences, Stanford University School of Medicine, Stanford, Calif.; the VA Palo Alto Health Care System, Palo Alto, Calif.; and the Department of Psychiatry, Olive View-UCLA Medical Center, Sylmar, Calif.
authors.forename: Paul E
authors.initials: PE
authors.lastname: Keck
authors.affiliation: From the Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA, Los Angeles; the Jane and Terry Semel Institute of Neuroscience and Human Behavior, University of California, Los Angeles; the Department of Psychiatry, VA Greater Los Angeles Healthcare System, West Los Angeles Healthcare Center, Los Angeles; the Department of Biostatistics, School of Public Health, University of California, Los Angeles; the Lindner Center of HOPE, Mason, Ohio; the Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati; the Department of Psychiatry and Biobehavioral Sciences, Stanford University School of Medicine, Stanford, Calif.; the VA Palo Alto Health Care System, Palo Alto, Calif.; and the Department of Psychiatry, Olive View-UCLA Medical Center, Sylmar, Calif.
authors.forename: Ana
authors.initials: A
authors.lastname: Aquino-Elias
authors.affiliation: From the Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA, Los Angeles; the Jane and Terry Semel Institute of Neuroscience and Human Behavior, University of California, Los Angeles; the Department of Psychiatry, VA Greater Los Angeles Healthcare System, West Los Angeles Healthcare Center, Los Angeles; the Department of Biostatistics, School of Public Health, University of California, Los Angeles; the Lindner Center of HOPE, Mason, Ohio; the Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati; the Department of Psychiatry and Biobehavioral Sciences, Stanford University School of Medicine, Stanford, Calif.; the VA Palo Alto Health Care System, Palo Alto, Calif.; and the Department of Psychiatry, Olive View-UCLA Medical Center, Sylmar, Calif.
authors.forename: Brian E
authors.initials: BE
authors.lastname: Martens
authors.affiliation: From the Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA, Los Angeles; the Jane and Terry Semel Institute of Neuroscience and Human Behavior, University of California, Los Angeles; the Department of Psychiatry, VA Greater Los Angeles Healthcare System, West Los Angeles Healthcare Center, Los Angeles; the Department of Biostatistics, School of Public Health, University of California, Los Angeles; the Lindner Center of HOPE, Mason, Ohio; the Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati; the Department of Psychiatry and Biobehavioral Sciences, Stanford University School of Medicine, Stanford, Calif.; the VA Palo Alto Health Care System, Palo Alto, Calif.; and the Department of Psychiatry, Olive View-UCLA Medical Center, Sylmar, Calif.
authors.forename: E Grace
authors.initials: EG
authors.lastname: Fischer
authors.affiliation: From the Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA, Los Angeles; the Jane and Terry Semel Institute of Neuroscience and Human Behavior, University of California, Los Angeles; the Department of Psychiatry, VA Greater Los Angeles Healthcare System, West Los Angeles Healthcare Center, Los Angeles; the Department of Biostatistics, School of Public Health, University of California, Los Angeles; the Lindner Center of HOPE, Mason, Ohio; the Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati; the Department of Psychiatry and Biobehavioral Sciences, Stanford University School of Medicine, Stanford, Calif.; the VA Palo Alto Health Care System, Palo Alto, Calif.; and the Department of Psychiatry, Olive View-UCLA Medical Center, Sylmar, Calif.
authors.forename: Teri L
authors.initials: TL
authors.lastname: English
authors.affiliation: From the Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA, Los Angeles; the Jane and Terry Semel Institute of Neuroscience and Human Behavior, University of California, Los Angeles; the Department of Psychiatry, VA Greater Los Angeles Healthcare System, West Los Angeles Healthcare Center, Los Angeles; the Department of Biostatistics, School of Public Health, University of California, Los Angeles; the Lindner Center of HOPE, Mason, Ohio; the Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati; the Department of Psychiatry and Biobehavioral Sciences, Stanford University School of Medicine, Stanford, Calif.; the VA Palo Alto Health Care System, Palo Alto, Calif.; and the Department of Psychiatry, Olive View-UCLA Medical Center, Sylmar, Calif.
authors.forename: Janine
authors.initials: J
authors.lastname: Roach
authors.affiliation: From the Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA, Los Angeles; the Jane and Terry Semel Institute of Neuroscience and Human Behavior, University of California, Los Angeles; the Department of Psychiatry, VA Greater Los Angeles Healthcare System, West Los Angeles Healthcare Center, Los Angeles; the Department of Biostatistics, School of Public Health, University of California, Los Angeles; the Lindner Center of HOPE, Mason, Ohio; the Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati; the Department of Psychiatry and Biobehavioral Sciences, Stanford University School of Medicine, Stanford, Calif.; the VA Palo Alto Health Care System, Palo Alto, Calif.; and the Department of Psychiatry, Olive View-UCLA Medical Center, Sylmar, Calif.
authors.forename: Trisha
authors.initials: T
authors.lastname: Suppes
mesh_terms: D000328:Adult; D000339:Affect / Q000187:drug effects*; D001714:Bipolar Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D016651:Lithium Carbonate / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010352:Patient Dropouts; D011569:Psychiatric Status Rating Scales; D012306:Risk; D020280:Sertraline / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D016651:Lithium Carbonate; D020280:Sertraline
keywords: Antidepressants; Bipolar Depression; Bipolar II Disorder; Clinical Drug Studies; Drug Side Effects-Other; Lithium