Melatonin Treatment for Tardive Dyskinesia in Schizophrenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2011-05-31

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.

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Detailed Description

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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.

Conditions

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Tardive Dyskinesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Melatonin, antioxidant, oxidative stress

Melatonin is an active treatment for TD.

Group Type EXPERIMENTAL

Melatonin

Intervention Type DRUG

10mg/day, 12-week treatment

Placebo

Placebo look like the active drug, and same dose.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

10mg/day, 12-week treatment for TD

Interventions

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Melatonin

10mg/day, 12-week treatment

Intervention Type DRUG

Placebo

10mg/day, 12-week treatment for TD

Intervention Type DRUG

Other Intervention Names

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APRD00742

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No