Low doses of controlled-release paroxetine in the treatment of late-life depression: a randomized, placebo-controlled trial.
OBJECTIVE
To evaluate the efficacy and tolerability of low daily doses of controlled-release (CR) paroxetine in patients with late-life depression.


METHODS
This was a 10-week, multicenter, placebo-controlled, double-blind, fixed-dose trial randomly assigning patients >or= 60 years old to daily doses of paroxetine CR 12.5 mg (N = 168), paroxetine CR 25 mg (N = 177), or placebo (N = 180). Patients had major depressive disorder (DSM-IV criteria) and 17-item Hamilton Rating Scale for Depression (HAM-D) total scores of >or= 18. The primary efficacy variable was the change from baseline to study endpoint in total HAM-D scores. The study was conducted from June 2003 to October 2004.


RESULTS
The drug/placebo difference in HAM-D change from baseline at study endpoint was -1.8 (95% CI = -3.41 to -0.19, p = .029) for paroxetine CR 12.5 mg, and -3.3 (95% CI = -4.84 to -1.68, p < .001) for paroxetine CR 25 mg. A significantly larger percentage of patients achieved remission (HAM-D total score <or= 7 at endpoint) with paroxetine CR 25 mg (41%), but not with 12.5 mg (31%), as compared with placebo (28%) (p = .008). Both doses of paroxetine CR also achieved statistical significance compared to placebo for the Clinical Global Impressions-Severity of Illness scale (p < .01) and the patient-rated measures of depression severity (p < .05) and quality of life (p <or= .001). Both active treatments were generally well tolerated, with adverse event withdrawal rates of 6%, 8%, and 7% for paroxetine CR 12.5 mg, paroxetine CR 25 mg, and placebo, respectively.


CONCLUSIONS
These data demonstrate that paroxetine CR 12.5 mg and 25 mg daily are efficacious and well tolerated in the treatment of major depressive disorder in patients >or= 60 years of age, although effect sizes are relatively smaller with the 12.5 mg/day dose.
Rapaport
Mark Hyman
MH
Department of Psychiatry, David Geffen School of Medicine at UCLA, Cedars-Sinai Medical Center, Los Angeles, California 90048, USA. mark.rapaport@cshs.org
Lydiard
R Bruce
RB
Pitts
Cornelius D
CD
Schaefer
Desiree
D
Bartolic
Edward I
EI
Iyengar
Malini
M
Carfagno
Michelle
M
Lipschitz
Alan
A
D000368:Aged; D018687:Antidepressive Agents, Second-Generation / Q000008:administration & dosage* / Q000009:adverse effects; D003692:Delayed-Action Preparations; D003865:Major Depressive Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017374:Paroxetine / Q000008:administration & dosage* / Q000009:adverse effects; D017060:Patient Satisfaction; D010555:Personality Inventory; D011788:Quality of Life / Q000523:psychology; D013375:Substance Withdrawal Syndrome / Q000175:diagnosis
D018687:Antidepressive Agents, Second-Generation; D003692:Delayed-Action Preparations; D017374:Paroxetine