Original articleOlanzapine Augmentation of Fluoxetine for Refractory Generalized Anxiety Disorder: A Placebo Controlled Study
Section snippets
Methods and Materials
This study was approved by the Institutional Review Board at the Massachusetts General Hospital, and all subjects received and signed informed consent prior to study entry. Eligible subjects were male and female outpatients, aged 18 to 72 years, with a primary diagnosis of DSM-IV generalized anxiety disorder (comorbid depression or dysthymia and other anxiety disorders except for PTSD and OCD were permitted if GAD was considered primary by the clinician and patient based on disorder severity
Results
During the initial 6 weeks of the trial (weeks 0 to 6) on open fluoxetine treatment, overall HAM-A scores dropped from 24.6 to 17.9 (paired t = 5.85; p < .001) and CGI-S scores dropped from 4.7 (moderately to severely ill) to 3.8 (mild to moderately ill) (paired t = 4.95; p < .001) in the ITT sample. It should be noted that at week 6 randomization, there was, by chance, a trend for lower severity on the HAM-A in the olanzapine group (mean 17.4 ± 6.5) compared with the placebo group (mean 22.6 ±
Discussion
This is, to our knowledge, one of the few prospective, randomized controlled studies of any adjunctive pharmacotherapy for patients with GAD remaining symptomatic despite initial pharmacotherapy and the first to be reported for olanzapine augmentation of an SSRI. Although conclusions from this study are limited by its small randomized sample size and pilot nature of our findings, there was evidence for our hypothesis of significantly greater response rates (defined as a 50% reduction in HAM-A
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