Melatonin Treatment for Tardive Dyskinesia in Schizophrenia
|ClinicalTrials.gov Identifier: NCT01391390|
Recruitment Status : Completed
First Posted : July 12, 2011
Last Update Posted : July 12, 2016
|Condition or disease||Intervention/treatment||Phase|
|Tardive Dyskinesia||Drug: Melatonin Drug: Placebo||Not Applicable|
- 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.
- 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 (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The Effect of Melatonin Treatment on Tardive Dyskinesia and Oxidative Stress: A Double-Blind Placebo-Controlled Trial|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||May 2011|
Experimental: Melatonin, antioxidant, oxidative stress
Melatonin is an active treatment for TD.
10mg/day, 12-week treatment
Other Name: APRD00742
Placebo Comparator: Placebo
Placebo look like the active drug, and same dose.
10mg/day, 12-week treatment for TD
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01391390
|Beijing HuiLongGuan hospital|
|Beijing, China, 100096|
|Study Chair:||Lian Y Cao, MD||Beijing HuiLongGuan Hospital|