Melatonin Treatment for Tardive Dyskinesia: A Double-blind, Placebo-Controlled, Crossover Study | Clinical Pharmacy and Pharmacology | JAMA Psychiatry | JAMA Network
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Original Article
November 2001

Melatonin Treatment for Tardive Dyskinesia: A Double-blind, Placebo-Controlled, Crossover Study

Author Affiliations

From the Abarbanel Mental Health Center, Bat-Yam, Israel (Drs Shamir, Barak, Shalman, and Elizur); Sackler Faculty of Medicine (Drs Shamir, Barak, Shalman, Elizur, and Weizman), Department of Neurobiochemistry, Faculty of Life Sciences (Dr Zisapel), and Department of Psychology (Mr Tarrasch), Tel Aviv University, Neurim Pharmaceuticals Ltd (Drs Laudon and Zisapel), and Tel Aviv Mental Health Center (Dr Weizman), Tel Aviv, Israel.

Arch Gen Psychiatry. 2001;58(11):1049-1052. doi:10.1001/archpsyc.58.11.1049

Background  Antipsychotics remain the mainstay of drug intervention in the management of schizophrenia. However, long-term treatment with antipsychotics is associated with a variety of movement disorders, the most disabling of which is tardive dyskinesia (TD), which occurs in up to 50% of patients hospitalized with chronic schizophrenia. The pathophysiology of TD is still unclear and no definite treatment exists. Both dopamine receptor supersensitivity and oxidative stress–induced neurotoxicity in the nigrostriatal system are apparently implicated. The pineal hormone melatonin is a potent antioxidant and attenuates dopaminergic activity in the striatum and dopamine release from the hypothalamus. Thus, it may have a beneficial effect for both the treatment and prevention of TD.

Methods  Using a double-blind, placebo-controlled, crossover study, we evaluated the efficacy of 10 mg/d of melatonin for 6 weeks in 22 patients with schizophrenia and TD. The primary outcome measure was the change from baseline in Abnormal Involuntary Movement Scale (AIMS) score.

Results  The decrease (mean ± SD) in AIMS score was 2.45 ± 1.92 for the melatonin and 0.77 ± 1.11 for the placebo treatment groups (P<.001). No adverse events or side effects were noted.

Conclusion  This is the first clinical evidence for efficacy of melatonin in the treatment of TD.