Melatonin Treatment for Tardive Dyskinesia in Schizophrenia

Not Applicable

Completed

• Conditions: Tardive Dyskinesia
• Interventions: Drug: Placebo; Drug: Melatonin

• Registration Number: NCT01391390
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2008-09
• Primary Completion: 2011-04
• Study Completion: 2011-05
• Study First Submitted: 2011-07-07
• Study First Submitted QC: 2011-07-11
• Study First Posted: 2011-07-12
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-10
• Last Update Posted: 2016-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo look like the active drug, and same dose.
Melatonin, antioxidant, oxidative stress	Melatonin	Melatonin is an active treatment for TD.

Primary Outcome Measures

Name	Time	Method
the Abnormal Involuntary Movement Scale (AIMS)	12 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Beijing HuiLongGuan hospital; 🇨🇳 Beijing, China