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 |