Melatonin Treatment for Tardive Dyskinesia in Schizophrenia

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Brief Title

Melatonin Treatment for Tardive Dyskinesia in Schizophrenia

Official Title

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

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.
    

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


Primary Outcome

the Abnormal Involuntary Movement Scale (AIMS)

Secondary Outcome

 the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

Condition

Tardive Dyskinesia

Intervention

Melatonin

Study Arms / Comparison Groups

 Melatonin, antioxidant, oxidative stress
Description:  Melatonin is an active treatment for TD.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

120

Start Date

September 2008

Completion Date

May 2011

Primary Completion Date

April 2011

Eligibility 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.
      

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

Lian Y Cao, MD, , 

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT01391390

Organization ID

BJ-7072035


Responsible Party

Principal Investigator

Study Sponsor

Beijing HuiLongGuan Hospital

Collaborators

 Stanley Medical Research Institute

Study Sponsor

Lian Y Cao, MD, Study Chair, Beijing HuiLongGuan Hospital


Verification Date

July 2016