This is a double-blind, randomized, placebo-controlled trial of melatonin as an add-on therapy to antipsychotics will be performed to examine the effects of melatonin on tardive dyskinesia symptoms and cognitive deficits in 120 patients with established tardive dyskinesia (TD). This study addresses a free radical hypothesis of TD.
1. Since it has been proposed that neuroleptic-induced increases in free-radical production may relate to the development of TD, the investigators hypothesize that melatonin, an effective antioxidant, may attenuate the severity of tardive dyskinesia symptoms. 2. Due to increased cognitive deficits in patients with TD and implication of oxidative stress in cognitive impairment, the investigators hypothesize that both cognitive impairment and tardive dyskinesia symptoms may be induced by the same pathophysiological stimulus--oxidative stress. Hence, the investigators further hypothesize that both tardive dyskinesia symptoms and cognitive deficits in patients with TD may be improved by melatonin simultaneously.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
Beijing HuiLongGuan hospital
Beijing, China
the Abnormal Involuntary Movement Scale (AIMS)
Time frame: 12 weeks
the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Time frame: 12 weeks
the Positive and Negative Syndrome Scale (PANSS)
Time frame: 12 weeks
the Simpson-Angus Scale for extrapyramidal side effects (SAS)
Time frame: 12 weeks
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