Eligible for inclusion in the review were randomised controlled trials (RCTs) that compared atypical antipsychotics (clozapine, olanzapine, risperidone, ziprasidone, quetiapine, aripiprazole, amisulpride) with placebo for the treatment of post-traumatic stress disorder (PTSD), either as a monotherapy or add-on therapy. There were no restrictions on duration of treatment, comorbidities, concomitant medications, presence of psychotic symptoms, severity and duration of PTSD, type of trauma experienced, inpatient or outpatient treatment.
The primary outcome measure was mean change in total score on the Clinician Administered PTSD Scale (CAPS), or the Davidson Trauma Scale (DTS). Secondary outcome measures were mean changes in the subscores of CAPS, response rates measured on the Clinical Global Impression-Improvement (CGI-I) score, number of drop-outs, adverse events, and weight change.
Atypical antipsychotics in the included trials were risperidone or olanzapine only. Duration of treatment ranged from five to 16 weeks. In most of the trials patients were also receiving anti-depressants. Included trials varied in the type of trauma experienced: combat only trauma; non-combat trauma (childhood abuse, sexual abuse, domestic violence); and a mixture of combat and non-combat trauma. All trials concerning combat trauma included men only.
The authors did not state how many reviewers were involved in the study selection process.