A direct comparison of presenting characteristics of depressed outpatients from primary vs. specialty care settings: preliminary findings from the STAR*D clinical trial☆

Received 19 April 2004; accepted 28 October 2004.

Abstract

Purpose

No study has directly compared the clinical features of depression for patients entering clinical trials using identical enrollment criteria at primary care (PC) and specialty care (SC) settings. The Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study (http://www.star-d.org) provides a unique opportunity to provide this comparison for patients with a major depressive disorder (MDD) requiring treatment.

Subjects and Methods

We report baseline data for the first 1500 patients enrolled in this trial involving 41 clinic sites (18 PC, 23 SC). Broadly inclusive eligibility criteria required that patients have a DSM-IV diagnosis of nonpsychotic MDD, have not failed an adequate medication trial during their current episode and score ≥14 on the 17-item Hamilton Rating Scale for Depression (HAM-D17). Primary outcomes included the 30-item Inventory of Depressive Symptomatology–Clinician-Rated (IDS-C30) and the HAM-D17.

Results

Specialty care and PC patients had equivalent degrees of depressive severity (IDS-C30=35.8; HAM-D17=20.4). Specialty care patients were almost twice as likely to report a prior suicide attempt than PC patients (21% vs. 12%, P<.0001) and slightly less likely to endorse suicidal ideation in the past week (45.0% vs. 50.8%, P=.006). The only other distinguishing core symptoms were a slightly lower likelihood of PC patients endorsing depressed mood (95.2% vs. 97.7%, P=.032) or anhedonia (66.3% vs. 70.7%, P=.042, IDS-C30) and a lower likelihood of PC patients endorsing weight loss (IDS-C30). HAM-D17 results were identical.

Conclusion

Depressive severity was not different, and symptomatic presentations did not differ substantially. Major depressive disorder is more similar than different among patients at SC and PC settings. Thus, similar clinical and research methods for screening, detecting and measuring treatment outcomes can be applied in both settings.

Keywords: Primary care, Depression, Suicidality, Clinical trial

a Department of Psychiatry, University of North Carolina School of Medicine, Chapel Hill, NC 27599-7160, USA

b Department of Psychiatry, University of Texas Southwestern Medical Center at Dallas, Dallas, TX 75390, USA

c Epidemiology Data Center, Graduate School of Public Health, University of Pittsburgh School of Medicine, Pittsburgh, PA 15261, USA

d Depression Clinical and Research Program, Massachusetts General Hospital, Boston, MA 02114, USA

e Department of Family Medicine, University of Michigan, Ann Arbor, MI 48109, USA

f Department of Psychiatry, Medical College of Virginia, Richmond, VA 23220, USA

g Department of Family Medicine, UCLA School of Medicine, Harbor City, CA 90710, USA

Corresponding author. Tel.: +1 919 966 8028; fax: +1 919 843 4370.

☆ This project has been funded in whole or in part with Federal funds from the National Institute of Mental Health, National Institutes of Health, under Contract N01MH90003. Dr. Gaynes was supported in part by an NIMH K23 Career Development Award (MH01951-03).

PII: S0163-8343(04)00132-X

doi:10.1016/j.genhosppsych.2004.10.003

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