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


METHODS
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.


METHODS
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.
Friedman
Edward S
ES
Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA. friedmane@upmc.edu
Wisniewski
Stephen R
SR
Gilmer
William
W
Nierenberg
Andrew A
AA
Rush
A John
AJ
Fava
Maurizio
M
Zisook
Sidney
S
Balasubramani
G K
GK
Trivedi
Madhukar H
MH
D000293:Adolescent; D000328:Adult; D001741:Black or African American / Q000523:psychology / Q000706:statistics & numerical data; D000368:Aged; D015283:Citalopram / Q000009:adverse effects* / Q000627:therapeutic use; D003710:Demography; D003865:Major Depressive Disorder / Q000175:diagnosis* / Q000188:drug therapy* / Q000453:epidemiology; D039721:Diagnostic and Statistical Manual of Mental Disorders; D016903:Drug Monitoring; D005260:Female; D006801:Humans; D006998:Hypochondriasis / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D009315:National Institute of Mental Health (U.S.); D010352:Patient Dropouts / Q000706:statistics & numerical data; D018579:Patient Selection; D011320:Primary Health Care / Q000706:statistics & numerical data; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use; D012720:Severity of Illness Index; D013313:Stress Disorders, Post-Traumatic / Q000453:epidemiology; D019966:Substance-Related Disorders / Q000453:epidemiology; D011795:Surveys and Questionnaires; D014481:United States; D044465:White People / Q000523:psychology / Q000706:statistics & numerical data; D055815:Young Adult
D015283:Citalopram; D017367:Selective Serotonin Reuptake Inhibitors