Treatment-associated suicidal ideation and adverse effects in an open, multicenter trial of fluoxetine for major depressive episodes.
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.


METHODS
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.
Perlis
Roy H
RH
Depression Clinical and Research Program, Massachusetts General Hospital and Harvard Medical School, Boston, MA 02114, USA. rperlis@partners.org
Beasley
Charles M
CM
Wines
James D
JD
Tamura
Roy N
RN
Cusin
Cristina
C
Shear
Deborah
D
Amsterdam
Jay
J
Quitkin
Frederick
F
Strong
Robert E
RE
Rosenbaum
Jerrold F
JF
Fava
Maurizio
M
D000293:Adolescent; D000328:Adult; D000368:Aged; D000553:Ambulatory Care; D003865:Major Depressive Disorder / Q000175:diagnosis / Q000188:drug therapy*; D004334:Drug Administration Schedule; D004358:Drug Therapy / Q000706:statistics & numerical data*; D005260:Female; D005473:Fluoxetine / Q000009:adverse effects*; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects*; D012720:Severity of Illness Index; D013406:Suicide, Attempted / Q000523:psychology*; D011795:Surveys and Questionnaires
D005473:Fluoxetine; D017367:Selective Serotonin Reuptake Inhibitors