Melatonin Treatment for Tardive Dyskinesia in Schizophrenia
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||The Effect of Melatonin Treatment on Tardive Dyskinesia and Oxidative Stress: A Double-Blind Placebo-Controlled Trial|
- the Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- the Positive and Negative Syndrome Scale (PANSS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- the Simpson-Angus Scale for extrapyramidal side effects (SAS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||September 2008|
|Study Completion Date:||May 2011|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
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
Other Name: Placebo
- 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.