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Melatonin Treatment for Tardive Dyskinesia in Schizophrenia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01391390
First Posted: July 12, 2011
Last Update Posted: July 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Xiang Yang Zhang, Beijing HuiLongGuan Hospital
  Purpose
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.

Condition Intervention
Tardive Dyskinesia Drug: Melatonin Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Melatonin Treatment on Tardive Dyskinesia and Oxidative Stress: A Double-Blind Placebo-Controlled Trial

Resource links provided by NLM:


Further study details as provided by Xiang Yang Zhang, Beijing HuiLongGuan Hospital:

Primary Outcome Measures:
  • the Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 120
Study Start Date: September 2008
Study Completion Date: May 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Melatonin, antioxidant, oxidative stress
Melatonin is an active treatment for TD.
Drug: Melatonin
10mg/day, 12-week treatment
Other Name: APRD00742
Placebo Comparator: Placebo
Placebo look like the active drug, and same dose.
Drug: Placebo
10mg/day, 12-week treatment for 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. diagnosis of both schizophrenia and TD;
  2. duration of TD symptoms longer than 1 year;
  3. on stable doses of antipsychotic drug for at least 6 months;
  4. between 18 and 70 years of age.

Exclusion Criteria:

  1. comorbid neurological illness other than TD;
  2. if they have received vitamin C or vitamin E within 1 month before the start of the study;
  3. alcohol/drug abuse;
  4. acute, unstable medical condition;
  5. pregnant or breastfeeding female;
  6. use of other antioxidants.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01391390


Locations
China
Beijing HuiLongGuan hospital
Beijing, China, 100096
Sponsors and Collaborators
Beijing HuiLongGuan Hospital
Stanley Medical Research Institute
Investigators
Study Chair: Lian Y Cao, MD Beijing HuiLongGuan Hospital
  More Information

Responsible Party: Xiang Yang Zhang, Director, Biological Psychiatry Center, Beijing HuiLongGuan Hospital
ClinicalTrials.gov Identifier: NCT01391390     History of Changes
Other Study ID Numbers: BJ-7072035
First Submitted: July 7, 2011
First Posted: July 12, 2011
Last Update Posted: July 12, 2016
Last Verified: July 2016

Keywords provided by Xiang Yang Zhang, Beijing HuiLongGuan Hospital:
Tardive Dyskinesia
Schizophrenia
Melatonin
Oxidative Stress
Antioxidant

Additional relevant MeSH terms:
Dyskinesias
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants


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