An Open-Label, 12-Week Clinical and Sleep EEG Study of Nefazodone in Chronic Combat-Related Posttraumatic Stress Disorder
J Clin Psychiatry 2001;62:789-796
© Copyright 2014 Physicians Postgraduate Press, Inc.
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Background: We examined the effects of
nefazodone on polysomnographic sleep measures and subjective
reports of sleep quality and nightmares, as well as other
symptoms, in patients with chronic combat-related posttraumatic
stress disorder (PTSD) during a 12-week, open-label clinical
trial. To our knowledge, this is the first polysomnographic study
of treatment in patients with PTSD.
Method: The subjects were 12 male veterans (mean
age = 54 years) who met DSM-IV diagnostic criteria for PTSD (mean
duration = 30 years). All but 1 patient also met DSM-IV criteria
for major depressive disorder. Patients were evaluated weekly
with clinical ratings in an open-label clinical trial.
Polysomnographic recordings for 2 consecutive nights were
obtained before treatment and at 2, 4, 8, and 12 weeks. The dose
of nefazodone was adjusted according to individual clinical
needs. Final mean daily dose was 441 mg.
Results: The patients reported significantly
fewer nightmares and sleep problems during treatment.
Nevertheless, contrary to studies in depressed patients,
nefazodone did not significantly affect polysomnographic sleep
measures compared with baseline. In addition, the patients showed
significant improvement in the Clinical Global Impressions of
PTSD symptoms (global score, hyperarousals and intrusions
subscales), the Clinician-Administered PTSD Scale (global,
hyperarousal, and intrusions subscales), the Hamilton Rating
Scale for Depression (HAM-D), and the Beck Depression Inventory
Conclusion: These patients with chronic,
treatment-resistant, combat-related PTSD showed significant
improvement of subjective symptoms of nightmares and sleep
disturbance, as well as depression and PTSD symptoms, in this
12-week open-label clinical trial. Nevertheless, objective
polysomnographic sleep measures did not change. Further studies,
including double-blind, placebo-controlled trials, are needed to
extend these findings and to understand the relationships between
the physiology of sleep and symptoms of poor sleep and