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. 2018 Mar 19;2018(3):CD000208. doi: 10.1002/14651858.CD000208.pub2

NCT01391390 2011.

Trial name or title Melatonin treatment for tardive dyskinesia in schizophrenia.
Methods Allocation: randomised
 Blindness: double‐blind (Subject, Investigator)
 Duration: 12 weeks
 Design: parallel
 Setting: China
Participants Diagnosis: diagnosis of both schizophrenia and TD; duration of TD symptoms longer than 1 year; on stable doses of antipsychotic drug for at least 6 months.
N = 120
Sex: male and female
Age: 18 to 70 years old
Interventions 1. Melatonin (other Name: APRD00742)10mg/day, 12‐week treatment. N = 60.
2. Placebo 10mg/day, 12‐week treatment. N = 60
Outcomes Primary: AIMS at 12 weeks
Secondary: the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS); the Positive and Negative Syndrome Scale (PANSS); the Simpson‐Angus Scale for extrapyramidal side effects (SAS)
Starting date September 2008
Contact information Lian Y Cao, MD, Beijing Hui‐Long‐Guan Hospital
Notes Sponsor: Beijing HuiLongGuan Hospital, Stanley Medical Research Institute
 Other study ID: BJ‐7072035