Patients were recruited primarily through advertising, although a minority of patients were referred from primary care clinics. All patients provided written, informed consent prior to beginning study procedures. The study enrolled men and women, aged 18–65 years, who met DSM-IV criteria for current major depressive disorder and who had never previously received treatment for a mood disorder. We defined “previous treatment” as patient-reported treatment for major depression, dysthymia, or depressive disorder not otherwise specified with either 1) a marketed antidepressant at a minimum effective dose for 4 or more consecutive weeks or 2) 4 or more sessions of an evidence-based and structured psychotherapy for depression (i.e., CBT, behavior therapy, interpersonal therapy, or behavioral marital therapy). Patients who had received prior supportive therapy were eligible, but they were not permitted to participate in such psychotherapy during the study.
Eligible patients had a primary psychiatric diagnosis of nonpsychotic major depressive disorder and a 17-item Hamilton Depression Rating Scale (HAM-D) (28 (link)) total score ≥18 at screening and ≥15 at the baseline visit. Exclusion criteria included a lifetime history of bipolar disorder, primary psychotic disorder, or dementia, or a current (past 12 months) diagnosis of obsessive-compulsive disorder, eating disorder, or dissociative disorder. Additionally, patients were excluded if they met DSM-IV criteria for substance abuse within 3 months, substance dependence within 12 months of the randomization visit, or if their urine tested positive for drugs of abuse. Additional exclusionary criteria included any lifetime treatment with citalopram, escitalopram, or duloxetine. Women who were, or planned on becoming, pregnant or breast-feeding during the trial were excluded, as were any patients with significant uncontrolled medical conditions, or any condition that could interfere with the study or the interpretation of the study results.
Eligible patients had a primary psychiatric diagnosis of nonpsychotic major depressive disorder and a 17-item Hamilton Depression Rating Scale (HAM-D) (28 (link)) total score ≥18 at screening and ≥15 at the baseline visit. Exclusion criteria included a lifetime history of bipolar disorder, primary psychotic disorder, or dementia, or a current (past 12 months) diagnosis of obsessive-compulsive disorder, eating disorder, or dissociative disorder. Additionally, patients were excluded if they met DSM-IV criteria for substance abuse within 3 months, substance dependence within 12 months of the randomization visit, or if their urine tested positive for drugs of abuse. Additional exclusionary criteria included any lifetime treatment with citalopram, escitalopram, or duloxetine. Women who were, or planned on becoming, pregnant or breast-feeding during the trial were excluded, as were any patients with significant uncontrolled medical conditions, or any condition that could interfere with the study or the interpretation of the study results.