No open-label trials were included on tricyclic antidepressants. There were two prior RCTs comparing phenelzine and impramine to placebo (Frank et al., 1988; Kosten et al., 1992), but those were superseded by the updated and more complete1991 study by Kosten and colleagues so only that study was included. See Table 3-7 for a summary of the three included clinical trials.
Open trials of mirtazepine were not included (Kim et al., 2005). One study was excluded because it was not randomized (Connor and Sutherland et al., 1999). One study was excluded because it was a comparative trial (Chung et al., 2004) (compared mirtazapine and sertraline). See Table 3-8 for a summary of the one included clinical trial.
Open trials of nefazodone were not included (Garfield et al., 2001). There were two head-to-head trials comparing nefazodone to sertraline that were not included (McRae et al., 2004; Saygin et al., 2002). See Table 3-9 for a summary of the one included clinical trial.
Open trials of venlafaxine were not included nor was the one head-to-head trial comparing venlafaxine to sertraline and paroxetine (Smajkic et al., 2001). See Table 3-10 for a summary of the two included clinical trials.
The committee identified studies of naltrexone, cycloserine, and inositol, but not all met inclusion criteria. An RCT of naltrexone, an opioid antagonist, was conducted in patients with alcohol dependence, approximately one-third of whom also had PTSD, finding reductions in alcohol intake and improvements in CAPS scores (Petrakis et al., 2006). The committee found the single study difficult to interpret with respect to the overall treatment of PTSD, while recognizing that the study suggests a benefit to using naltrexone in an important subpopulation.
The participants in the single study of D-cycloserine had suffered from work or traffic accidents, terrorist attacks, and physical abuse. The age range was 22 to 61 years. Duration of illness ranged from 1 to 20 years. Race/ethnicity was not reported. This was a double-blind study with a placebo control and a crossover study design. Treatment lasted 12 weeks, and the study did not have post-treatment follow-up. The PTSD outcome measure used in this study was CAPS-Total (Heresco-Levy et al., 2002).
The participants in the inositol study suffered trauma from combat, serious accidents, and physical assault. The mean age was 40 years, with a range from 25 to 56 years. Time since trauma ranged from 6 months to 28 years. Race/ethnicity was not reported. This was a double-blind study