Predictors of relapse in a study of duloxetine treatment in patients with major depressive disorder.
BACKGROUND
Using data from a relapse prevention study of duloxetine treatment for adults with major depressive disorder (MDD), we examined demographic- and illness-related variables to identify factors that may predict relapse of MDD.


METHODS
Post-hoc analyses, using the Cox proportional hazards model, were performed on data from a study designed to compare the time to relapse of MDD in duloxetine- and placebo-treated patients. Patients received open-label duloxetine 60 mg/day during a 12-week acute phase, and those who met response criteria were randomly assigned to duloxetine 60 mg/day (N=136) or placebo (N=142) during a 26-week double-blind continuation phase.


RESULTS
Significant predictors of relapse were VAS back pain score at entry >30, HAMD(17) total score at randomization >7, and geography (Europe vs. US). Four significant treatment-by-predictor interactions were identified: the SQ-SS pain subscale score at entry>median of 4, VAS overall pain score at entry >30, VAS overall pain score at entry>median of 26, and VAS overall pain score at randomization>median of 7. In the "greater severity" category, the risk of relapse was significantly lower for duloxetine-treated patients compared with placebo-treated patients.


CONCLUSIONS
These were post-hoc analyses.


CONCLUSIONS
Higher levels of pain severity and depressive symptoms and a US geographical location were significant predictors of relapse in patients with MDD.
Fava
Maurizio
M
Massachusetts General Hospital, Boston, MA 02114, United States. MFava@Partners.org
Wiltse
Curtis
C
Walker
Daniel
D
Brecht
Stephan
S
Chen
Andrew
A
Perahia
David
D
D000208:Acute Disease; D000328:Adult; D000928:Antidepressive Agents / Q000627:therapeutic use*; D003865:Major Depressive Disorder / Q000175:diagnosis* / Q000188:drug therapy* / Q000523:psychology; D039721:Diagnostic and Statistical Manual of Mental Disorders; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D000068736:Duloxetine Hydrochloride; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000175:diagnosis / Q000453:epidemiology; D010147:Pain Measurement; D011237:Predictive Value of Tests; D015995:Prevalence; D011446:Prospective Studies; D012008:Recurrence; D012720:Severity of Illness Index; D013876:Thiophenes / Q000627:therapeutic use*
D000928:Antidepressive Agents; D013876:Thiophenes; D000068736:Duloxetine Hydrochloride