This multicenter study compared the efficacy and safety of
citalopram and placebo in a population of moderately to severely depressed patients with
melancholia. This randomized, double-blind, parallel-group study compared
citalopram (flexible dose; 20-80 mg/day) with placebo in 180 psychiatric outpatients with a DSM-III diagnosis of major depression or
bipolar disorder, depressed, who also met DSM-III criteria for
melancholia. Following a 1-week placebo washout period, patients meeting study entry criteria were randomized to 4 weeks of double-blind treatment with either
citalopram or placebo. Efficacy measures included the Hamilton Rating Scale for Depression (HAM-D), the Clinical Global Impressions (CGI) Scale, and the Zung Self-Rating Depression Scale. Patients treated with
citalopram showed significantly greater improvement at endpoint than placebo patients on the HAM-D, CGI, and Zung scales. On the HAM-D,
citalopram patients exhibited significantly greater improvement than placebo patients after 1 week of double-blind treatment and at all subsequent study visits. Endpoint analyses of the HAM-D subscales demonstrated that
citalopram produced significant improvement of the psychomotor retardation, cognitive disturbance, sleep disturbance, and
melancholia symptom clusters.
Nausea, dry mouth,
somnolence,
dizziness, and increased sweating were reported at higher rates by
citalopram-treated patients than by placebo-treated patients, but there were no significant
citalopram-placebo differences in the incidence of activation (e.g., anxiety, nervousness,
insomnia) or sexual dysfunction. Analysis of electrocardiograms, vital signs, and laboratory tests did not reveal any clinically significant effects of
citalopram treatment. The results of this study indicate that
citalopram is safe and effective in the treatment of depressed patients with
melancholia, and is associated with a favorable side effect profile and a potentially rapid onset of action.