 |
|
Efficacy of Olanzapine in Combination With Valproate or Lithium in the Treatment of Mania in Patients Partially Nonresponsive to Valproate or Lithium Monotherapy
Mauricio Tohen, MD, DrPH;
K. N. Roy Chengappa, MD;
Trisha Suppes, MD, PhD;
Carlos A. Zarate, Jr, MD;
Joseph R. Calabrese, MD;
Charles L. Bowden, MD;
Gary S. Sachs, MD;
David J. Kupfer, MD;
Robert W. Baker, MD;
Richard C. Risser, MSc;
Elisabeth L. Keeter, RN, MSN;
Peter D. Feldman, PhD;
Gary D. Tollefson, MD, PhD;
Alan Breier, MD
Arch Gen Psychiatry. 2002;59:62-69.
Background A 6-week double-blind, randomized, placebo-controlled trial was conducted
to determine the efficacy of combined therapy with olanzapine and either valproate
or lithium compared with valproate or lithium alone in treating acute manic
or mixed bipolar episodes.
Methods The primary objective was to evaluate the efficacy of olanzapine (5-20
mg/d) vs placebo when added to ongoing mood-stabilizer therapy as measured
by reductions in Young Mania Rating Scale (YMRS) scores. Patients with bipolar
disorder (n = 344), manic or mixed episode, who were inadequately responsive
to more than 2 weeks of lithium or valproate therapy, were randomized to receive
cotherapy (olanzapine + mood-stabilizer) or monotherapy (placebo + mood-stabilizer).
Results Olanzapine cotherapy improved patients' YMRS total scores significantly
more than monotherapy (-13.11 vs -9.10; P
= .003). Clinical response rates ( 50% improvement on YMRS) were significantly
higher with cotherapy (67.7% vs 44.7%; P<.001).
Olanzapine cotherapy improved 21-item Hamilton Depression Rating Scale (HAMD-21)
total scores significantly more than monotherapy (4.98 vs 0.89 points; P<.001). In patients with mixed-episodes with moderate
to severe depressive symptoms (DSM-IV mixed episode;
HAMD-21 score of 20 at baseline), olanzapine cotherapy improved HAMD-21
scores by 10.31 points compared with 1.57 for monotherapy (P<.001). Extrapyramidal symptoms (Simpson-Angus Scale, Barnes Akathisia
Scale, Abnormal Involuntary Movement Scale) were not significantly changed
from baseline to end point in either treatment group. Treatment-emergent symptoms
that were significantly higher for the olanzapine cotherapy group included
somnolence, dry mouth, weight gain, increased appetite, tremor, and slurred
speech.
Conclusion Compared with the use of valproate or lithium alone, the addition of
olanzapine provided superior efficacy in the treatment of manic and mixed
bipolar episodes.
From the Department of Psychiatry, Harvard Medical School, McLean Hospital,
Belmont, Mass (Dr Tohen); Lilly Research Laboratories, Indianapolis, Ind (Drs
Tohen, Baker, Feldman, Tollefson, and Breier, and Mr Risser and Ms Keeter);
Western Psychiatric Institute & Clinic, University of Pittsburgh Medical
Center, Pittsburgh, Pa (Drs Chengappa and Kupfer); Department of Psychiatry,
University of Texas Southwestern Medical Center, Dallas (Dr Suppes); Mood
and Anxiety Disorders Program, National Institute of Mental Health,
Bethesda, Md (Dr Zarate); Department of Psychiatry, Case Western Reserve,
Cleveland, Ohio (Dr Calabrese); Department of Psychiatry, Massachusetts General
Hospital, Harvard Medical School, Boston (Dr Sachs); Department of Psychiatry,
University of Texas Health Science Center, San Antonio (Dr Bowden). Drs Tohen, Feldman, Tollefson, and Breier and Mr Risser and Ms Keeter
are stockholders in Eli Lilly & Co.
THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES
|
Efficacy of Adjunctive Aripiprazole to Either Valproate or Lithium in Bipolar Mania Patients Partially Nonresponsive to Valproate/Lithium Monotherapy: A Placebo-Controlled Study
Vieta et al.
Am. J. Psychiatry 2008;165:1316-1325.
ABSTRACT
| FULL TEXT
Second-Generation Antipsychotic Agents in the Treatment of Acute Mania: A Systematic Review and Meta-analysis of Randomized Controlled Trials
Scherk et al.
Arch Gen Psychiatry 2007;64:442-455.
ABSTRACT
| FULL TEXT
Pharmacological management of acute mania - does current prescribing practice reflect treatment guidelines?
Streeruwitz et al.
J Psychopharmacol 2007;21:206-209.
ABSTRACT
Guideline Watch (November 2005): Practice Guideline for the Treatment of Patients with Bipolar Disorder, 2nd Edition
Hirschfeld
Focus 2007;5:34-39.
ABSTRACT
| FULL TEXT
Bibliography BIPOLAR DISORDER
Focus 2007;5:40-43.
FULL TEXT
Olanzapine co-therapy in bipolar disorder
Hosalli and Jayaram
Br. J. Psychiatry 2005;187:486-487.
FULL TEXT
Risperidone in the treatment of acute mania: Double-blind, placebo-controlled study
Khanna et al.
Br. J. Psychiatry 2005;187:229-234.
ABSTRACT
| FULL TEXT
Pharmacokinetics of Aripiprazole and Concomitant Lithium and Valproate
Citrome et al.
J Clin Pharmacol 2005;45:89-93.
ABSTRACT
| FULL TEXT
Efficacy of olanzapine combined with valproate or lithium in the treatment of dysphoric mania
Baker et al.
Br. J. Psychiatry 2004;185:472-478.
ABSTRACT
| FULL TEXT
A Mood Stabilizer With Risperidone or Haloperidol for Mania
ANDRADE
Am. J. Psychiatry 2004;161:2140-2140.
FULL TEXT
ADVERSE DRUG REACTIONS IN THE OROFACIAL REGION
Scully and Bagan
Crit. Rev. Oral Biol. Med. 2004;15:221-239.
ABSTRACT
| FULL TEXT
Demystifying the Disease State: Understanding Diagnosis and Treatment Across the Bipolar Spectrum
Lewis
J Am Psychiatr Nurses Assoc 2004;10:S6-S15.
ABSTRACT
Relapse prevention in bipolar I disorder: 18-month comparison of olanzapine plus mood stabiliser v. mood stabiliser alone
TOHEN et al.
Br. J. Psychiatry 2004;184:337-345.
ABSTRACT
| FULL TEXT
A 12-Week, Double-blind Comparison of Olanzapine vs Haloperidol in the Treatment of Acute Mania
Tohen et al.
Arch Gen Psychiatry 2003;60:1218-1226.
ABSTRACT
| FULL TEXT
Evidence-Based Guidelines for Treating Bipolar Disorder: Recommendations from the British Association for Psychopharmacology
Goodwin
J Psychopharmacol 2003;17:149-173.
ABSTRACT
Mood stabilisers plus risperidone or placebo in the treatment of acute mania: International, double-blind, randomised controlled trial
YATHAM et al.
Br. J. Psychiatry 2003;182:141-147.
ABSTRACT
| FULL TEXT
Bipolar Disorders: A Brief Guide to Diagnosis and Treatment
Jefferson
Focus 2003;1:7-14.
FULL TEXT
An epigenetic mouse model for molecular and behavioral neuropathologies related to schizophrenia vulnerability
Tremolizzo et al.
Proc. Natl. Acad. Sci. USA 2002;99:17095-17100.
ABSTRACT
| FULL TEXT
The addition of olanzapine to valproate or lithium for acute manic or mixed bipolar episodes reduced manic symptoms
Gardner
Evid. Based Ment. Health 2002;5:89-89.
FULL TEXT
Adjunctive Olanzapine in Refractory Mania
JWatch Psychiatry 2002;2002:6-6.
FULL TEXT
|
