Oral isotretinoin is presently regarded as the drug of choice for the treatment of severe and recalcitrant acne.

Although its use has been associated with various psychiatric side effects, the casual relationship between these manifestations and oral isotretinoin still remains in dispute.

The purpose of this study was to investigate the incidence of psychopathological reactions in patients with severe acne orally treated with isotretinoin.

Seventy-two (72) patients with severe acne and thirty-six (36) healthy volunteers acne enrolled in the study from January 2003 and August 2009. Acne patients were allocated either to oral isotretinoin (1mg/kg/day) (N=36) or to topical treatment (N=36). All patients and controls were separately interviewed by two psychiatrists before and 1, 3 and 6 months after onset of treatment. Their psychological status was evaluated using SCID-I, SCID-II (DSM-IV) and Hamilton Scale for Depression and Anxiety.

A statistical significant increase in the incidence of depression, mood and/or anxiety disorders was observed in the group of isotretinoin-treated acne patients as compared to the group of those topically treated and to healthy controls. No association between development of symptoms of mental disorder and duration of treatment with isotretinoin was detected.

In view of the above findings it seems reasonable to suggest that oral isotretinoin may be capable of causing anxiety and/or depressive or other mood disorders in patients with severe acne. Close psychiatric monitoring should be included in the investigations that are routinely performed throughout oral isotretinoin treatment of these patients.