Regular Article

Treatment-Associated Suicidal Ideation and Adverse Effects in an Open, Multicenter Trial of Fluoxetine for Major Depressive Episodes
Roy H. Perlis^a, Charles M. Beasley, Jr.^b, James D. Wines, Jr.^c,, Roy N. Tamura^b, Cristina Cusin^a,1, Deborah Shear^a, Jay Amsterdam^d, Frederick Quitkin^†e, Robert E. Strong^{f, 1}, Jerrold F. Rosenbaum^a, Maurizio Fava<sup>a

a</sup>Depression Clinical and Research Program, Massachusetts General Hospital and Harvard Medical School, Boston, Mass.,
^bLilly Research Laboratories, Eli Lilly & Co., Indianapolis, Ind.,
^cMcLean Hospital and Harvard Medical School, Belmont, Mass.,
^dDepression Research Unit, University of Pennsylvania Medical Center, Philadelphia, Pa.,
^eNew York State Psychiatric Institute, New York, N.Y., and
^fUniversity of Utah, Salt Lake City, Utah, USA

Address of Corresponding Author

Psychother Psychosom 2007;76:40-46 (DOI: 10.1159/000096363)

  Key Words

• Fluoxetine
• Suicidal ideation

  Abstract

Background: Some reports suggest that a subset of depressed patients may experience suicidality - that is increase or emergence of suicidal ideation (SI) or behavior - after initiation of an antidepressant. The time course and clinical correlates of this phenomenon have not been characterized in detail. Method: We conducted a secondary analysis of a multicenter, prospective, open, 12-week trial of fluoxetine 20 mg in outpatients with nonpsychotic major depressive episodes. Adverse effects and other clinical features associated with the emergence of suicidality, defined using item 3 of the Hamilton Depression Rating Scale, were examined using Cox regression models. Results: Among 414 subjects without SI at baseline, 59 (14.3%) reported SI on at least 1 postbaseline visit. In a Cox regression, emergence of activation and worsening of depression severity were independently associated with emergence of SI, along with female gender, younger age and having thoughts that life was not worth living prior to treatment. Treatment response and remission were significantly less likely among subjects who developed SI. Conclusions: New SI was relatively common in this trial of fluoxetine and associated with the emergence of activation and overall symptomatic worsening. Whether prophylaxis against or aggressive treatment of adverse events can decrease emergence of SI merits further study.

Copyright © 2007 S. Karger AG, Basel

  Author Contacts

Roy H. Perlis, MD
Massachusetts General Hospital
15 Parkman St., WACC 812, Boston, MA 02114 (USA)
Tel. +1 617 726 7426, Fax +1 617 724 3028
E-Mail rperlis@partners.org

  Article Information

Number of Print Pages : 7
Number of Figures : 1, Number of Tables : 2, Number of References : 50