Clinical evaluation of the efficacy of pivagabine in the treatment of mood and adjustment disorders.

Depression and distress have in common hypercortisolism, a high turn-over of cerebral monoamines and a wide clinical variability. Results of a clinical open trial with pivagabine (4-[(2,2-dimethyl-1-oxopropyl) amino]butanoic acid, CAS 69542-93-4, Tonerg) on 22 young patients affected by dysthymic disorders and on 38 older patients affected by adjustment disorders following different stressors (mourning, retirement and recovery in institutions of assistance) are reported. Oral treatment with 1800 mg pivagabine lasting 30 days showed in both groups a significant improvement of the psychic state with variations from 50 to 80% of the criteria reported in the Hamilton Rating Scale for Depression (HDRS) and for anxiety (HARS) and in the Self-rating Anxiety Scale (SAS). Good tolerance of the drug and the complete absence of serious side effects considerably contributed to the clinical success.