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Cited by 200Bipolar Disorder and TreatmentSchizophrenia research and treatmentPersonality Disorders and Psychopathology

GERI-BD: A Randomized Double-Blind Controlled Trial of Lithium and Divalproex in the Treatment of Mania in Older Patients With Bipolar Disorder

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Young, Robert C., Mulsant, Benoit H., Sajatovic, Martha, Gildengers, Ariel G., Gyulai, Laszlo, Al Jurdi, Rayan K., Beyer, John, Evans, Jovier +43 more·2017·American Journal of Psychiatry
DOI 10.1176/appi.ajp.2017.15050657PMC PMC6214451
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Abstract

OBJECTIVE: Clinicians treating older patients with bipolar disorder with mood stabilizers need evidence from age-specific randomized controlled trials. The authors describe findings from a first such study of late-life mania. METHOD: The authors compared the tolerability and efficacy of lithium carbonate and divalproex in 224 inpatients and outpatients age 60 or older with bipolar I disorder who presented with a manic, hypomanic, or mixed episode. Participants were randomly assigned, under double-blind conditions, to treatment with lithium (target serum concentration, 0.80-0.99 mEq/L) or divalproex (target serum valproate concentration, 80-99 μg/mL) for 9 weeks. Participants with an inadequate response after 3 weeks received open adjunctive risperidone. The authors hypothesized that divalproex would be better tolerated and more efficacious than lithium. Tolerability was assessed based on a measure of sedation and on the proportions of participants achieving target concentrations. Efficacy was assessed with the Young Mania Rating Scale (YMRS). RESULTS: Attrition rates were similar for lithium and divalproex (14% and 18% at week 3 and 51% and 44% at week 9, respectively). The groups did not differ significantly in sedation. Participants in the lithium group tended to experience more tremor. Similar proportions of participants in the lithium and divalproex groups achieved target concentrations (57% and 56%, respectively). A longitudinal mixed model of improvement (change from baseline in YMRS score) favored lithium (change in score, 3.90; 97.5% CI=1.71, 6.09). Nine-week response rates did not differ significantly between the lithium and divalproex groups (79% and 73%, respectively). The need for adjunctive risperidone was low and similar between groups (17% and 14%, respectively). CONCLUSIONS: Both lithium and divalproex were adequately tolerated and efficacious; lithium was associated with a greater reduction in mania scores over 9 weeks.

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  1. [16]Schaffer CB, Garvey MJ. Use of lithium in acutely manic elderly patients. Clin Gerontologist. 1984; 3: 58– 60.
  2. [17]American Psychiatric Association. Diagnostic and Statistical Manual DSM-IV-TR. 4th ed. ed. Washington, D.C.: American Psychiatric Press, Inc.; 1994.
  3. [18]First MB, Spitzer R, Williams J, Gibbon M. Structured clinical interview for DSM-IV patient version (SCID-P). American Psychiatric Press, Inc. 1995.

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Authors
Young, R. C., Mulsant, B. H., Sajatovic, M., Gildengers, A. G., Gyulai, L., Al Jurdi, R. K., Beyer, J., Evans, J., Banerjee, S., Greenberg, R., Marino, P., Kunik, M. E., Chen, P., Barrett, M., Schulberg, H. C., Bruce, M. L., Reynolds, C. F., Alexopoulos, G. S., for the GERI-BD Study Group, Evans, L. D., Klimstra, S., Kotbi, N., Gabriele, M., Jacobson, C., Kwentus, J., Marangell, L., Cassidy, K., Dines, P., Ramirez, L., Thase, M., Etemad, B., Gur, R., Moberg, P., Oslin, D., Streim, J., TenHave, T., Weiss, D., Connelly, P., Holsinger, T., Krishnan, K. R. R., Mani, M., Miller, J., Weisler, R., Emanuel, J., Hyams, A., Miranda, D., Pollock, B., Rajii, T. K., Seals, K., Whyte, E., & Zachariah, E.
Affiliations
  • Centre for Addiction and Mental Health (CA)
  • From the Department of Psychiatry and the Department of Healthcare Policy and Research, Weill Cornell Medicine, New York, and New York Presbyterian Hospital, New York; the Department of Psychiatry, University of Toronto, and the Centre for Addiction and Mental Health, Toronto; the Department of Psychiatry, University of Pittsburgh, Pittsburgh; the Department of Psychiatry, Case Western Reserve University School of Medicine, Cleveland; the Department of Psychiatry, Louis Stokes Cleveland VA Medical Center...
ORCID
Venue
American Journal of Psychiatry
Publisher
American Psychiatric Association Publishing
Published
2017-11-01
Volume
174
Issue
11
Pages
1086-1093
ISSN
  • 0002-953X (ISSN-L)
  • 1535-7228
DOI
10.1176/appi.ajp.2017.15050657
PMC
PMC6214451
OpenAlex
W2744819261
Cited by
200
References
32
Citations by year
2026: 9 · 2025: 7 · 2024: 16 · 2023: 13 · 2022: 45 · 2021: 13 · 2020: 42 · 2019: 42 · 2018: 6 · 2017: 6 · 2016: 1
FWCI
21.53
Type
journal article
Language
en
Open access
Locations
  • American Journal of Psychiatry (publishedVersion)
  • PubMed (publishedVersion)
  • PubMed Central (acceptedVersion)
Funders
  • National Institute of Mental Health (U01MH074511, P30MH085943, U01MH068846, P30MH090333, R01MH084921, P30MH071944, U01MH068847, K24MH069430, K02MH067028)
  • National Center for Research Resources (UL1RR024989, UL1RR024996)
Topics
  • Health Sciences › Medicine › Psychiatry and Mental health › Bipolar Disorder and Treatment
  • Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
  • Social Sciences › Psychology › Clinical Psychology › Personality Disorders and Psychopathology
Keywords
bipolar disorder, mania, older adults, lithium carbonate, divalproex, valproic acid, mood stabilizers, treatment tolerability, sedation, tremor, serum drug concentration, Young Mania Rating Scale, age-specific treatment
MeSH terms
Aged, Bipolar Disorder, Double-Blind Method, Drug Therapy, Combination, Female, Humans, Male, Middle Aged, Antipsychotic Agents, Valproic Acid, Lithium Carbonate, Treatment Outcome, Antimanic Agents, Risperidone

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