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NCT Number: NCT01391390

Melatonin Treatment for Tardive Dyskinesia in Schizophrenia

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.

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Key information

Conditions

Tardive Dyskinesia Central Nervous System Diseases Dyskinesia, Drug-Induced Dyskinesias Mental Disorders Movement Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing HuiLongGuan hospital

Beijing, 100096, China

About this study

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • comorbid neurological illness other than TD;
  • if they have received vitamin C or vitamin E within 1 month before the start of the study;
  • alcohol/drug abuse;
  • acute, unstable medical condition;
  • pregnant or breastfeeding female;
  • use of other antioxidants.

Treatment and study plan

Melatonin

Drug

10mg/day, 12-week treatment

Other names: APRD00742

Placebo

Drug

10mg/day, 12-week treatment for TD

Primary outcomes

  1. the Abnormal Involuntary Movement Scale (AIMS)

    Time frame: 12 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Beijing HuiLongGuan Hospital

Other

Collaborators

  • Stanley Medical Research Institute

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jul 12, 2011
Registry last updated
Jul 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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