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| Name | Class |
|---|---|
| Stanley Medical Research Institute | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melatonin, antioxidant, oxidative stress | Experimental | Melatonin is an active treatment for TD. |
|
| Placebo | Placebo Comparator | Placebo look like the active drug, and same dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin | Drug | 10mg/day, 12-week treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| the Abnormal Involuntary Movement Scale (AIMS) | 12 weeks |
| Measure | Description | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lian Y Cao, MD | Beijing HuiLongGuan Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing HuiLongGuan hospital | Beijing | 100096 | China |
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| ID | Term |
|---|---|
| D000071057 | Tardive Dyskinesia |
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D004409 | Dyskinesia, Drug-Induced |
| D020820 | Dyskinesias |
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Placebo | Drug | 10mg/day, 12-week treatment for TD |
|
| 12 weeks |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |