Melatonin Treatment for Tardive Dyskinesia in Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Xiang Yang Zhang, Beijing Hui-Long-Guan Hospital
ClinicalTrials.gov Identifier:
NCT01391390
First received: July 7, 2011
Last updated: November 10, 2013
Last verified: November 2013
  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
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

Resource links provided by NLM:


Further study details as provided by Beijing Hui-Long-Guan Hospital:

Primary Outcome Measures:
  • the Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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
Other Name: Placebo

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01391390

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

No publications provided

Responsible Party: Xiang Yang Zhang, Director, Biological Psychiatry Center, Beijing Hui-Long-Guan Hospital
ClinicalTrials.gov Identifier: NCT01391390     History of Changes
Other Study ID Numbers: BJ-7072035
Study First Received: July 7, 2011
Last Updated: November 10, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Beijing Hui-Long-Guan 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
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014