ABSTRACT
Based on evidence suggesting anxiolytic properties of the atypical antipsychotic olanzapine, this study was conducted to evaluate whether olanzapine may be efficacious in treating social anxiety disorder (SAD). This study was an 8-week, double-blind, placebo-controlled evaluation of olanzapine as monotherapy in which 12 patients with the DSM-IV diagnosis of SAD were randomized to either olanzapine (n = 7) or placebo (n = 5). An initial dose of 5 mg/day was titrated to a maximum of 20 mg/day. Baseline to endpoint scores from the Brief Social Phobia Scale (BSPS), Social Phobia Inventory (SPIN), Liebowitz Social Anxiety Scale and Sheehan Disability Scale, as well as Clinical Global Impression-Improvement ratings, were compared for olanzapine versus placebo. Seven subjects completed all 8 weeks of the study, four in the olanzapine group and three in the placebo group. In the intent-to-treat analysis, olanzapine yielded greater improvement than placebo on the primary measures: BSPS (p = 0.02) and SPIN (p = 0.01). Both treatments were well tolerated, although the olanzapine group had more drowsiness and dry mouth. Olanzapine and placebo were both associated with negligible weight gain. Olanzapine was superior to placebo on the primary outcome measures in this preliminary study of SAD. Additional studies of olanzapine as a treatment for SAD are warranted.
Subject(s)
Antipsychotic Agents/therapeutic use , Phobic Disorders/drug therapy , Pirenzepine/analogs & derivatives , Pirenzepine/therapeutic use , Adolescent , Adult , Aged , Antipsychotic Agents/administration & dosage , Antipsychotic Agents/adverse effects , Benzodiazepines , Female , Humans , Male , Middle Aged , Olanzapine , Phobic Disorders/psychology , Pilot Projects , Pirenzepine/administration & dosage , Pirenzepine/adverse effects , Psychiatric Status Rating ScalesABSTRACT
PURPOSE: In response to earlier reports that raised concerns about the tolerability of fluoxetine in the treatment of posttraumatic stress disorder (PTSD), this study was conducted to systematically delineate treatment-emergent symptoms (TES) associated with fluoxetine treatment of PTSD. METHODS: Sixty-five patients with PTSD enrolled in one of two identical-protocol, 12-week studies and received double-blind fluoxetine or placebo. TES data were obtained using a patient-rated checklist, Severity of Symptoms Scale (SOSS). RESULTS: Only a single patient discontinued treatment due to medication side effects. Compared to placebo, only three statistically significant TES (nausea, diarrhea, and thirst) occurred more frequently in fluoxetine subjects. Fluoxetine was not associated with any statistically significant activating effects. There were no statistically significant associations between the total number of TES experienced and treatment, gender, or comorbid depressive or panic disorders. CONCLUSIONS: This systematic assessment of TES indicated that PTSD patients tolerated fluoxetine well without pronounced activating side effects.
