Sociodemographic, clinical, and treatment characteristics associated with worsened depression during treatment with citalopram: results of the NIMH STAR(*)D trial.

Context: Outcomes of antidepressant medication treatment for major depressive disorder include remission, response, and nonresponse. But nonresponse can include depression that worsened over the course of treatment, an outcome that has received scant attention.
Objective: To describe baseline sociodemographic, clinical, and treatment characteristics associated with worsened depression during a trial of citalopram. DESIGN, PARTICIPANTS, AND SETTINGS: Open-label clinical trial of 2,876 adult outpatients seen in 18 primary and 23 psychiatric-care settings.
Intervention: Citalopram was delivered using measurement-based care and flexible dosing with the aim of achieving symptom remission. Symptom and side effect ratings were obtained at each treatment visit.
Main Outcome Measures: Worsened depression was defined as an exit score >or=3 points above the pretreatment (baseline) score on the 16-item QIDS-SR. Baseline sociodemographic, clinical, and treatment characteristics were examined for association with worsened depression.
Results: Of 2,864 outpatients who returned for >or=2 post baseline visits, 150 (5.2%) had worsened depression at study exit. Baseline characteristics independently associated with increased worsened depression included African-American race (OR=2.02), having less than a college education (OR=2.36), posttraumatic stress disorder (OR=1.78), drug abuse (OR=1.97), hypochondriasis (OR=2.74). Participants with worsened depression spent less time in treatment; had fewer treatment visits; exited the study sooner; had more frequent, intense, and burdensome adverse effects; and were more intolerant of medication.
Conclusions: The presence of certain baseline characteristics indicated a greater likelihood of worsened depression during antidepressant treatment. Patients with these characteristics should be monitored closely during treatment and may be candidates for more aggressive treatment.