Journal of Affective Disorders
Volume 87, Issue 1 , Pages 115-119, July 2005

Is treatment-associated hypomania rare with duloxetine: Secondary analysis of controlled trials in non-bipolar depression

  • David L. Dunner

      Affiliations

    • Department of Psychiatry and Behavioral Sciences, University of Washington Center for Anxiety and Depression, 4225 Roosevelt Way NE, Ste 306C, Seattle, WA 98105, United States
    • Corresponding Author InformationCorresponding author. Tel.: +1 206 543 6768; fax: +1 206 543 7565.
    • ,
  • Deborah N. D'Souza

      Affiliations

    • Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, United States
    • ,
  • Daniel K. Kajdasz

      Affiliations

    • Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, United States
    • ,
  • Michael J. Detke

      Affiliations

    • Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, United States
    • ,
  • James M. Russell

      Affiliations

    • Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, United States

Received 13 July 2004; accepted 7 February 2005.

Abstract 

Background

Selective serotonin (5-HT) and norepinephrine (NE) reuptake inhibitors (SNRIs) like duloxetine have the efficacy of tricyclic antidepressants (TCAs) with a more tolerable side-effect profile. Bipolar disorder is often undetected, with the most common misdiagnosis being unipolar depression. Studies have suggested that treatment of bipolar and unipolar depression with heterocyclic TCAs may increase the risk of switch rate to mania. Studies of antidepressants in unipolar major depression show a small risk of mania or hypomania, presumably because some bipolar depressives were mistakenly studied. This study investigated the rate of hypomania, mania, and hypomanic-like symptoms observed during treatment with duloxetine in patients with major depression.

Methods

This was a retrospective analysis of data from eight placebo-controlled, double-blind, randomized clinical trials of duloxetine in patients with non-bipolar major depression.

Limitations

The studies were of limited duration. Manic or hypomanic symptoms were not elicited using standardized mania rating scale instruments.

Results

One case of mania occurred in the placebo group (0.1%), and two cases of hypomania were observed in the duloxetine-treated group (0.2%). Among hypomanic-like symptoms, only insomnia was significantly higher in the duloxetine group than in the placebo group (p<0.05).

Conclusions

Duloxetine was associated with a low incidence of treatment-emergent hypomania, mania, or hypomanic-like symptoms in patients with major depressive disorder (MDD). The low incidence reported here may be due to greater diagnostic diligence on the part of the investigators. It is possible that the cases reported likely reflect inclusion of misdiagnosed bipolar II patients rather than true unipolar MDD cases. The effect of duloxetine in patients with bipolar depression is not known.

Keywords: Duloxetine, Major depressive disorder, Hypomania, Mania, Unipolar

To access this article, please choose from the options below

Login to an existing account or Register a new account.

  • Purchase this article for 31.50 USD (You must login/register to purchase this article)

    Online access for 24 hours. The PDF version can be downloaded as your permanent record.

  • Subscribe to this title

    Get unlimited online access to this article and all other articles in this title 24/7 for one year.

  • Claim access now

    For current subscribers with Society Membership or Account Number.

  • Visit SciVerse ScienceDirect to see if you have access via your institution.
 

PII: S0165-0327(05)00074-1

doi:10.1016/j.jad.2005.02.017

Journal of Affective Disorders
Volume 87, Issue 1 , Pages 115-119, July 2005

Article Tools