The psychopharmacotherapy of somatoform disorders (SD; ICD-10: F45) has been less frequently investigated and is not as well established as in other (neurotic) disorders of ICD-10 section F4, i.e. generalized anxiety disorder (GAD; ICD-10: F41.1). The atypical compound opipramol is very often used to treat SD and GAD in clinical practice in Germany. However, state-of-the-art controlled clinical trials have not yet been performed.

Two clinical trials were performed with the aim of confirming the efficacy and tolerability of opipramol in SD and GAD.

Both trials were performed as randomized, double-blind, placebo-controlled, multicenter studies. While the GAD trial was a three-arm study with opipramol (200 mg/day) vs. placebo and alprazolam (2 mg/day) for 28 days, the SD trial was a placebo-controlled two-arm study with a treatment duration of 42 days. Each group consisted of about 100 patients.

Significant differences (alpha = 0.05) were found for the primary efficacy criteria (HAMA total score in GAD, HAMA somatic subscore in SD) and most of the secondary criteria in favor of the active drug therapies. Considerable differences between the psychopathology of SD and GAD were detected.

The well-tolerated anxiolytic opipramol is the first psychotropic drug with proven efficacy in somatoform disorders with effects on symptoms of somatization, anxiety, and depression. The compound is also effective and safe in GAD.