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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01391390
Other study ID # BJ-7072035
Secondary ID
Status Completed
Phase N/A
First received July 7, 2011
Last updated July 10, 2016
Start date September 2008
Est. completion date May 2011

Study information

Verified date July 2016
Source Beijing HuiLongGuan Hospital
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date May 2011
Est. primary completion date April 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Melatonin
10mg/day, 12-week treatment
Placebo
10mg/day, 12-week treatment for TD

Locations

Country Name City State
China Beijing HuiLongGuan hospital Beijing

Sponsors (2)

Lead Sponsor Collaborator
Beijing HuiLongGuan Hospital Stanley Medical Research Institute

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary the Abnormal Involuntary Movement Scale (AIMS) 12 weeks No
Secondary the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) 12 weeks No
Secondary the Positive and Negative Syndrome Scale (PANSS) 12 weeks No
Secondary the Simpson-Angus Scale for extrapyramidal side effects (SAS) 12 weeks No
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