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| | | ![]() Symptom Clusters for Post-Traumatic Stress Disorder Vary From DSM-IV in Therapeutics Trials: Presented at ECNP By Paula Moyer VIENNA, AUSTRIA -- October 18, 2007 -- Patients with post-traumatic stress disorder (PTSD) have symptom clusters that differ from those in the Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV), according to a team of investigators presenting their findings here at the 20th European College of Neuropsychopharmacology (ECNP) Congress. These results, like those of other PTSD factor analyses, challenge the structure of the DSM-IV diagnostic criteria for PTSD," said principal investigator Dan J. Stein, MD, PhD, Professor and Chair of Psychiatry, University of Cape Town, Cape Town, South Africa. Dr. Stein stressed, however, that comparisons are difficult because of the diversity of the people and the types of trauma in the trials the investigators studied. Dr. Stein and colleagues conducted the study because PTSD is common, chronic, and disabling, and is linked to an increased use of health-care resources as well a substantial functional impairment. The team wanted to analyse the symptom clusters in patients with PTSD who participated in two separate randomised, controlled trials. Separate factor analyses were conducted on the 17-item Clinician-Administered PTSD Scale (CAPS-SX17) data in double-blind, randomised, placebo-controlled trials. The trials were designed to assess the efficacy of venlafaxine extended release for PTSD. One trial involved 59 US sites for 12 weeks, while the other trial involved 56 international sites for 24 weeks. In both trials, participants were healthy adult outpatients who had been diagnosed with PTSD as defined by DSM-IV. The patients had had symptoms for at least 6 months and had a baseline CAPS-SX17 score of at least 60. The two trials involved a total of 687 patients. The present analysis was conducted on baseline CAPS-SX17 data from both trials. These items assess the 17 PTSD symptoms listed in the DSM-IV, divided into 3 symptom clusters: re-experiencing, avoidance/numbing, and hyperarousal subscales. The trials combined the frequency and intensity scores to create one summated score ranging from 0 to 8 for each item. The average baseline CAPS-SX17 score totals were 82.8 +- 14.8 in the 12-week trial and 81.9 +- 15.07 in the 24-week trial. The investigators' factor analyses showed a predominantly two-factor structure for the 12-week trial and a three-factor structure for the 24-week trial. Affective symptoms showed significant improvement with treatment on both the CAPS-SX17 and the Clinical Global Impressions - Severity (CGI-S) scales (P <.001 and P <.05, respectively). In both trials, the predominant cluster set or factor 1 included several affective symptoms: intrusive recollections, restricted range of affect, sense of foreshortened future, and difficulty falling or staying asleep. The clusters for factors 2 and 3 included several hyperarousal and re-experiencing symptoms. The symptoms with the most weight for hyperarousal were distressing dreams, feeling events were recurring, and exaggerated startle response. The symptoms with the most weight for factor 3 were diminished interest or participation in activities, irritability or outbursts of anger, and difficulty concentrating. The CAPS-SX17 items with the most weight were similar across both trials. The investigators concluded that symptoms related to affective dysregulation, as well as symptoms related to hyperarousal and re-experiencing, seemed to cluster. These findings varied from the symptom clusters noted in DSM-IV and measured on the CAPS-SX17 subscales. Dr. Stein and his investigative team recommended further investigation of the neurobiological substrates and treatment response of these factors. This study was funded by Bristol Myers Squibb.
[Presentation title: Symptoms of Post-Traumatic Stress Disorder: Examination of Factor Structure in 2 Separate Clinical Trials.]
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