An open-label, 12-week clinical and sleep EEG study of nefazodone in chronic combat-related posttraumatic stress disorder

Background. We examined the effects of nefazodone on polysomnographic sleep measures and subjective reports of sleep quality and nightmares, as well a s other symptoms, in patients with chronic combat-related posttraumatic str ess disorder (PTSD) during a 12-week, open-label clinical trial. To our kno wledge, this is the first polysomnographic study of treatment in patients w ith PTSD. Method: The subjects were 12 male veterans (mean age = 54 years) who met DS M-IV diagnostic criteria for PTSD (mean duration = 30 years). All but I pat ient also met DSM-IV criteria for major depressive disorder. Patients were evaluated weekly with clinical ratings in an open-label clinical trial. Pol ysomnographic recordings for 2 consecutive ni-hts were obtained before trea tment and at 2, 4, 8, and 12 weeks. The dose of nefazodone was adjusted acc ording to individual clinical needs. Final mean daily dose was 441 mg. Results: The patients reported significantly fewer nightmares and sleep pro blems during treatment. Nevertheless, contrary to studies in depressed pati ents, nefazodone did not significantly affect polysomnographic sleep measur es compared with baseline. In addition, the patients showed significant imp rovement in the Clinical Global Impressions of PTSD symptoms (global score, hyperarousals and intrusions subscales), the Clinician-Administered PTSD S cale (global, hyperarousal, and intrusions subscales), the Hamilton Rating Scale for Depression (HAM-D), and the Beck Depression Inventory (BDI). Conclusion: These patients with chronic, treatment-resistant, combat-relate d 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 sl eep measures did not change. Further studies, including double-blind, place bo-controlled trials, are needed to extend these findings and to understand the relationships between the physiology of sleep and symptoms of poor sle ep and nightmares.