Melatonin Treatment for Tardive Dyskinesia in Schizophrenia

NCT01391390 | Completed DMC

• 1 other identifier: BJ-7072035
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Tardive Dyskinesia

Keywords

Tardive Dyskinesia; Schizophrenia; Melatonin; Oxidative Stress; Antioxidant

Outcome Measures

Primary Outcomes (1)

• the Abnormal Involuntary Movement Scale (AIMS)

  12 weeks

Secondary Outcomes (3)

• 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

Study Arms (2)

Melatonin, antioxidant, oxidative stress

EXPERIMENTAL

Melatonin is an active treatment for TD.

Drug: Melatonin

Placebo

PLACEBO COMPARATOR

Placebo look like the active drug, and same dose.

Drug: Placebo

Interventions

Melatonin DRUG

10mg/day, 12-week treatment

Also known as: APRD00742

Melatonin, antioxidant, oxidative stress

Placebo DRUG

10mg/day, 12-week treatment for TD

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of both schizophrenia and TD;
• duration of TD symptoms longer than 1 year;
• on stable doses of antipsychotic drug for at least 6 months;
• between 18 and 70 years of age.

You may not qualify if:

• comorbid neurological illness other than TD;
• if they have received vitamin C or vitamin E within 1 month before the start of the study;
• alcohol/drug abuse;
• acute, unstable medical condition;
• pregnant or breastfeeding female;
• use of other antioxidants.

Sponsors & Collaborators

• Beijing HuiLongGuan Hospital: lead
• Stanley Medical Research Institute: collaborator

Study Sites (1)

Beijing HuiLongGuan hospital

Beijing, 100096, China

Location

MeSH Terms

Conditions

Tardive Dyskinesia; Schizophrenia

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Dyskinesia, Drug-Induced; Dyskinesias; Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Lian Y Cao, MD

  Beijing HuiLongGuan Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Biological Psychiatry Center

Study Record Dates

• First Submitted: July 7, 2011
• First Posted: July 12, 2011
• Study Start: September 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: May 1, 2011
• Last Updated: July 12, 2016

Record last verified: 2016-07

Locations

CN (1)