Melatonin Treatment for Tardive Dyskinesia in Schizophrenia

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Tardive Dyskinesia

Intervention / Treatment
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* Drug: Melatonin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Melatonin, antioxidant, oxidative stress<br>Melatonin is an active treatment for TD. | Drug: Melatonin<br>* 10mg/day, 12-week treatment<br>* Other names: APRD00742;|
| Placebo Comparator: Placebo<br>Placebo look like the active drug, and same dose. | Drug: Placebo<br>* 10mg/day, 12-week treatment for TD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Abnormal Involuntary Movement Scale (AIMS) |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) |  | 12 weeks | 
| the Positive and Negative Syndrome Scale (PANSS) |  | 12 weeks | 
| the Simpson-Angus Scale for extrapyramidal side effects (SAS) |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tardive Dyskinesia, Schizophrenia, Melatonin, Oxidative Stress, Antioxidant