Melatonin Treatment for Tardive Dyskinesia in Schizophrenia

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. Identifier: NCT01391390
Recruitment Status : Completed
First Posted : July 12, 2011
Last Update Posted : July 12, 2016
Stanley Medical Research Institute
Information provided by (Responsible Party):
Xiang Yang Zhang, Beijing HuiLongGuan Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Tardive Dyskinesia Drug: Melatonin Drug: Placebo Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
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
Study Start Date : September 2008
Actual Primary Completion Date : April 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  1. the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) [ Time Frame: 12 weeks ]
  2. the Positive and Negative Syndrome Scale (PANSS) [ Time Frame: 12 weeks ]
  3. the Simpson-Angus Scale for extrapyramidal side effects (SAS) [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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.

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 identifier (NCT number): NCT01391390

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

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

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

Additional relevant MeSH terms:
Tardive Dyskinesia
Dyskinesia, Drug-Induced
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants