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Does Isotretinoin Cause Depression?

Investigators found no evidence of a link.

The U.S. FDA has received increasing numbers of reports of depression and suicide in patients using isotretinoin. Though causation is still unproven, new product labeling and informed consent forms have been instituted. The question of isotretinoin-induced depression is complicated by the high baseline incidence of depression and suicide in the adolescent population and by the depression and stress associated with severe acne.

Investigators conducted a cohort study to evaluate changes in depressive symptoms among patients with moderate-to-severe acne who were treated with isotretinoin, compared with patients who received maximal conservative acne therapy. The investigators enrolled patients aged 12 to 19 from hospital-affiliated and community-based clinics in Missouri. Of 132 patients, 59 received isotretinoin, and 73 received conservative therapy; 101 patients completed the study; 75% of the isotretinoin group and 40% of the control group were male. After a dermatologist selected a treatment regimen in the usual fashion, the patient was invited to participate in the study. Before therapy and at 3 months of therapy, participants completed a standardized 20-item questionnaire on depression from the National Institutes of Mental Health. A score of 17 or higher indicated a significant risk for depression.

At baseline, 14% of the isotretinoin group and 19% of the conservative-therapy group scored 17 or higher. At 3-month follow-up, the percentages were 8% and 15% in the isotretinoin and conservative-treatment groups, respectively. The percentages of new-onset depression at 3 months were 4.1% and 3.8%, respectively. No differences were statistically significant. No patients receiving isotretinoin had suicide ideation during the course of therapy. One patient in the conservative-treatment group had suicide ideation at baseline.

Comment: Whether isotretinoin causes increased risk for depression and suicide is a difficult question. In this study, neither depressive symptoms nor suicide ideation increased with isotretinoin therapy, but we need randomized studies with larger numbers of subjects to confirm these findings (see JW Dermatol Oct 24 2000 for one large study that found no such association). It might be that rare individuals are genetically or metabolically predisposed to depression triggered by isotretinoin.

— Mary Wu Chang, MD

Published in Journal Watch Dermatology June 28, 2005

Citation(s):

Chia CY et al. Isotretinoin therapy and mood changes in adolescents with moderate to severe acne: A cohort study. Arch Dermatol 2005 May; 141:557-60.

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