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A Randomized Controlled Trial in Older Adults

John W. Williams, Jr, MD, MHS; James Barrett, MD; Tom Oxman, MD; Ellen Frank, PhD; Wayne Katon, MD; Mark Sullivan, MD; John Cornell, PhD; Anjana Sengupta, PhD

JAMA. 2000;284:1519-1526.

Context  Insufficient evidence exists for recommendation of specific effective treatments for older primary care patients with minor depression or dysthymia.

Objective  To compare the effectiveness of pharmacotherapy and psychotherapy in primary care settings among older persons with minor depression or dysthymia.

Design  Randomized, placebo-controlled trial (November 1995–August 1998).

Setting  Four geographically and clinically diverse primary care practices.

Participants  A total of 415 primary care patients (mean age, 71 years) with minor depression (n = 204) or dysthymia (n = 211) and a Hamilton Depression Rating Scale (HDRS) score of at least 10 were randomized; 311 (74.9%) completed all study visits.

Interventions  Patients were randomly assigned to receive paroxetine (n = 137) or placebo (n = 140), starting at 10 mg/d and titrated to a maximum of 40 mg/d, or problem-solving treatment–primary care (PST-PC; n = 138). For the paroxetine and placebo groups, the 6 visits over 11 weeks included general support and symptom and adverse effects monitoring; for the PST-PC group, visits were for psychotherapy.

Main Outcome Measures  Depressive symptoms, by the 20-item Hopkins Symptom Checklist Depression Scale (HSCL-D-20) and the HDRS; and functional status, by the Medical Outcomes Study Short-Form 36 (SF-36) physical and mental components.

Results  Paroxetine patients showed greater (difference in mean [SE] 11-week change in HSCL-D-20 scores, 0.21 [0.07]; P = .004) symptom resolution than placebo patients. Patients treated with PST-PC did not show more improvement than placebo (difference in mean [SE] change in HSCL-D-20 scores, 0.11 [0.13] ; P = .13), but their symptoms improved more rapidly than those of placebo patients during the latter treatment weeks (P = .01). For dysthymia, paroxetine improved mental health functioning vs placebo among patients whose baseline functioning was high (difference in mean [SE] change in SF-36 mental component scores, 5.8 [2.02]; P = .01) or intermediate (difference in mean [SE] change in SF-36 mental component scores, 4.4 [1.74]; P = .03). Mental health functioning in dysthymia patients was not significantly improved by PST-PC compared with placebo (P.12 for low-, intermediate-, and high-functioning groups). For minor depression, both paroxetine and PST-PC improved mental health functioning in patients in the lowest tertile of baseline functioning (difference vs placebo in mean [SE] change in SF-36 mental component scores, 4.7 [2.03] for those taking paroxetine; 4.7 [1.96] for the PST-PC treatment; P = .02 vs placebo).

Conclusions  Paroxetine showed moderate benefit for depressive symptoms and mental health function in elderly patients with dysthymia and more severely impaired elderly patients with minor depression. The benefits of PST-PC were smaller, had slower onset, and were more subject to site differences than those of paroxetine.

Author Affiliations: The South Texas Veterans Affairs Health Care System, Audie Murphy Division and Divisions of General Internal Medicine (Drs Williams and Cornell) and Geriatrics (Dr Cornell), University of Texas Health Science Center at San Antonio; Departments of Community and Family Medicine (Drs Barrett, Oxman, and Sengupta) and Psychiatry (Dr Oxman), Dartmouth Medical School, Hanover, NH; Department of Psychiatry, Western Psychiatric Institute and Clinic, University of Pittsburgh, Pittsburgh, Pa (Dr Frank); and Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle (Drs Katon and Sullivan).

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