Efficacy of Venlafaxine Extended Release in Patients With Major Depressive Disorder and Comorbid Generalized Anxiety Disorder
J Clin Psychiatry 2001;62(7):523-529
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Background: A subset of patients with comorbid
major depressive disorder and generalized anxiety disorder (GAD)
was examined from a double-blind, placebo-controlled study
comparing the efficacy and safety of venlafaxine extended release
(XR) and fluoxetine.
Method: From a total of 368 patients, 92
patients meeting DSM-IV criteria for major depressive disorder
who also had comorbid GAD were identified. The comparison group
comprised 276 evaluable noncomorbid patients. Patients received
venlafaxineXR (75-225 mg/day), fluoxetine (20-60 mg/day), or
placebo for 12weeks. Efficacy evaluations included Hamilton
Rating Scale for Depression (HAM-D), Hamilton Rating Scale for
Anxiety (HAM-A), and Clinical Global Impressions (CGI) scale.
Results: By the final assessment at week 12,
comorbid patients in the venlafaxine XR group, but not in the
fluoxetine group, showed a significantly greater decrease than
those in the placebo group in the primary efficacy variables of
mean HAM-D and HAM-A total scores (p < .05, pairwise
comparison). In comorbid patients, significant pairwise
differences were noted between venlafaxine XR and placebo at week
12 for the secondary variables of HAM-D anxiety-somatization and
retardation factors, HAM-D depressed mood item, HAM-A psychic
anxiety factor, the Hospital Anxiety and Depression scale (HAD)
anxiety subscale score, and the Covi Anxiety Scale score.
Fluoxetine was significantly different from placebo only on the
HAD depression subscale score. Response, defined as >= 50%
decrease in symptoms score, was achieved in 66% and 59% of the
comorbid patients for HAM-D and HAM-A, respectively, in the
venlafaxine XR group at week 12. This response was higher than
that seen with fluoxetine (52% and 45%) or placebo (36% and 24%).
Onset of efficacy appeared to be slower in comorbid than in
Conclusion: This is the first evidence from a
controlled study of the effectiveness of pharmacotherapy in
patients with comorbid major depressive disorder and GAD. The
delayed improvement in comorbid patients compared with
noncomorbid patients suggests that a longer treatment period may
be necessary in comorbid patients.