NCT01391390

Melatonin Treatment for Tardive Dyskinesia in Schizophrenia

The Effect of Melatonin Treatment on Tardive Dyskinesia and Oxidative Stress: A Double-Blind Placebo-Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Beijing HuiLongGuan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Tardive Dyskinesia

Interventions

Type	Name	Description
DRUG	Melatonin	10mg/day, 12-week treatment
DRUG	Placebo	10mg/day, 12-week treatment for TD

Timeline

• Start date: 2008-09-01
• Primary completion: 2011-04-01
• Completion: 2011-05-01
• First posted: 2011-07-12
• Last updated: 2016-07-12

Locations

1 site across 1 country: China