Melatonin Treatment for Tardive Dyskinesia in Schizophrenia

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01391390

Enrollment

120

Registered

2011-07-12

Start date

2008-09-30

Completion date

2011-05-31

Last updated

2016-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tardive Dyskinesia

Keywords

Tardive Dyskinesia, Schizophrenia, Melatonin, Oxidative Stress, Antioxidant

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.

Interventions

DRUGMelatonin

10mg/day, 12-week treatment

DRUGPlacebo

10mg/day, 12-week treatment for TD

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
the Abnormal Involuntary Movement Scale (AIMS)	12 weeks

Secondary

Measure	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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026