Melatonin Treatment for Tardive Dyskinesia in Schizophrenia

Tardive Dyskinesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01391390
• Other study ID #: BJ-7072035
• 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

• Dyskinesias
• Movement Disorders
• Tardive Dyskinesia

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