CAPS ~ 10) in those that were statistically significant. Most of the studies focused on a population of patients with PTSD that had some special feature, such as treatment refractory or psychotic symptoms. Thus the committee judged the overall body of evidence to be low quality. The committee is not confident that the effect is present; and further high-quality research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.

Conclusion: The committee concludes that the evidence is inadequate to determine the efficacy of the novel antipsychotics olanzapine and risperidone in the treatment of PTSD.3

Comment

Although the committee judged the evidence inadequate to determine the efficacy of risperidone as a treatment of PTSD in general populations, there are three studies suggesting efficacy for the adjunctive use of risperidone in individuals inadequately responsive to other therapy.

Exclusion Notes

No open-label studies were included (Ahearn et al., 2006; Aukst-Margeti et al., 2004)4. There was one head-to-head trial comparing olanzapine and fluphenazine, but because the efficacy for both of these drugs has not yet been proven, it was not considered in this review (Pivac et al., 2004). See Table 3-3 for a summary of the seven included clinical trials.

BENZODIAZEPINES

The committee identified only one placebo-controlled RCT of alprazolam with a primary PTSD outcome, which showed that the drug was ineffective. The participants in the study suffered from three different trauma types: combat-related (40 percent), motor vehicle accident, or accidental serious injury. The mean age was 37 years, with a range of 19–56 years. Duration of illness and time since exposure were not reported, nor was race/ethnicity. This study was double-blinded and included a placebo control. The treatment lasted 5 weeks and had no post-treatment follow-up. The outcome measure used was the PTSD Scale which consists of each of the 12 items that make up Diagnostic and Statistical Manual of Mental Disorders (DSM)-III criteria. However, the trial was very small (fewer than

3

Please refer to Dr. Thomas Mellman’s minority opinion on this conclusion in Appendix H.

4

This study also used sleep as its primary outcome.



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