Affective and anxiety comorbidity in post-traumatic stress disorder treatment trials of sertraline.

Comorbidity of mood and anxiety disorders is common in patients suffering from post-traumatic stress disorder (PTSD). The current study evaluated the efficacy and tolerability of sertraline in a subgroup of PTSD patients suffering from anxiety or depression comorbidity. Two multicenter, 12-week, double-blind, flexible-dose US studies of adult outpatients from the general population with a DSM-III-R diagnosis of PTSD evaluated the safety and efficacy of sertraline (50 to 200 mg/d) compared to placebo in the treatment of PTSD. The total severity score of the Clinician-Administered PTSD Scale (CAPS-2) and the Davidson Trauma Scale (DTS) were used to examine the effect of comorbidity on treatment outcome. Among the combined 395 subjects enrolled in the two trials, 32.9% had a comorbid depressive diagnosis (no anxiety diagnosis), 6.3% had a comorbid anxiety disorder diagnosis (no depression), 11.4% had both a depression and anxiety disorder diagnosis, and 49.4% had no comorbidity. The correlation, at baseline, between Hamilton Depression Rating Scale (HAM-D) total score and the three CAPS-2 clusters was 0.37 for the re-experiencing/intrusion cluster, 0.52 for the avoidance/numbing cluster, and 0.45 for the hyperarousal cluster. Patients suffering from PTSD complicated by a current diagnosis of both depression and an anxiety disorder showed the highest baseline CAPS-2 cluster score severity. Patients treated with sertraline improved significantly (P <.05) compared to placebo on both the CAPS-2 and DTS whether or not they had a comorbid depressive or anxiety disorder. Sertraline was well tolerated. The presence of comorbidity was associated with a modest and mostly nonspecific increase in the side effect burden of approximately 10% to 20% on both study treatments. Patients suffering from dual depression and anxiety disorder comorbidity benefited from somewhat higher doses (147 mg v 125 mg; P =.08). Similarly, the presence of dual comorbidity resulted in a modest but nonsignificant increase in the mean time to response from 4.5 weeks to 5.5 weeks. We conclude that sertraline (50 to 200 mg/d) is effective and well tolerated in the treatment of PTSD for patients suffering from a current, comorbid depressive or anxiety disorders.

RCT Entities:   Population Interventions Outcomes