Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01391390
Study type Interventional
Source Beijing HuiLongGuan Hospital
Contact
Status Completed
Phase N/A
Start date September 2008
Completion date May 2011

See also
  Status Clinical Trial Phase
Recruiting NCT02840760 - Repetitive Transcranial Magnetic Stimulation for the Treatment of the Tardive Dyskinesia. N/A
Completed NCT01688037 - NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder (KINECT Study) Phase 2
Withdrawn NCT03254186 - Safety and Efficacy of Propranolol in the Treatment of Tardive Dyskinesia Phase 2/Phase 3
Completed NCT02291861 - Addressing Involuntary Movements in Tardive Dyskinesia Phase 3
Completed NCT02274558 - A Phase 3 Study of NBI-98854 for the Treatment of Tardive Dyskinesia Phase 3
Completed NCT02198794 - Reducing Involuntary Movements in Participants With Tardive Dyskinesia Phase 3
Completed NCT01467089 - The Assessment of Movement Disorders Utilizing Live Two-Way Video N/A
Completed NCT04794413 - Pimavanserin Treatment in TS Early Phase 1
Recruiting NCT06011408 - Remote Monitoring and Detecting of Tardive Dyskinesia for Improving Patient Outcomes N/A
Recruiting NCT05859698 - Study of the Effectiveness of Valbenazine on Patient- and Clinician-Reported Outcomes in Participants With Tardive Dyskinesia Phase 4
Active, not recruiting NCT02252380 - ExAblate Transcranial MRgFUS for the Management of Treatment-Refractory Movement Disorders N/A
Terminated NCT00917293 - Safety and Efficacy of Pyridoxal 5' -Phosphate in the Treatment of Tardive Dyskinesia Phase 2
Completed NCT01543321 - Xenazine in Late Dyskinetic Syndrome With Neuroleptics Phase 3
Completed NCT02405091 - Safety and Tolerability Study of NBI-98854 for the Treatment of Tardive Dyskinesia Phase 3
Completed NCT03176771 - Efficacy and Safety of MT-5199 in Subjects With Tardive Dyskinesia Phase 2/Phase 3
Terminated NCT02524886 - Deep Brain Stimulation for Patients With Tardive Dyskinesia and or Dystonia N/A
Completed NCT02195700 - Aim to Reduce Movements in Tardive Dyskinesia Phase 2/Phase 3
Completed NCT02736955 - Rollover Study for Continuing Valbenazine (NBI-98854) Administration for the Treatment of Tardive Dyskinesia Phase 3
Completed NCT03497013 - Effect of tDCS on Cognition, Symptoms in Chronic Schizophrenia Patients With Tardive Dyskinesia N/A
Withdrawn NCT01908452 - Pyridoxal Kinase Activity in Tardive Dyskinesia Phase 3