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| Name | Class |
|---|---|
| Shanghai Wu Mengchao Medical Foundation | UNKNOWN |
| Shanghai Ankang Pharmaceutical Co.,LTD | UNKNOWN |
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The main purpose of this study is to determine the effects of add-on therapy of wuling capsule on depressive symptoms in patients with comorbidity of epilepsy and depression, to evaluate its influences on the frequency and severity of seizures, and to observe its effects on patients' sleeping condition, quality of life.
The phenomenon of epileptic patients who have psychiatric disorders is very common, of which the prevalence of depression is the highest and depression is also an independent risk factor affecting epileptic patients' quality of life. Due to some social factors, non-typical clinical symptoms and limited therapeutic methods(tricyclic antidepressants, lithium chloride and 5-serotonin uptake inhibitors may all have risks of lowing threshold of seizures), epileptic patients with depression are usually not be recognized and treated properly. Wuling capsule has been used in therapy of insomnia, nervous breakdowns and a previous small sample clinical trial revealed that it could improve mood disorders of epileptic patients and hadn't affected severity of seizures (not published). Therefore a multi-center, randomized, double-blinded and placebo-controlled superiority clinical trial will be carried out to determine the effects of add-on therapy of wuling capsule on depressive symptoms in patients with epilepsy, to evaluate its influences on the frequency and severity of seizures, and to observe its effects on patients' sleeping condition, quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wuling capsule | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| wuling capsule | Drug | orally, three tablets each time,three times a day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| symptoms of depression using the 17-item Hamilton Depression Rating Scale (HDRS) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| the frequency of seizures using diary | 3 months | |
| the severity of seizures using the National Hospital Seizure Severity Scale(NHS3) | 3 months | |
| the sleeping condition using Pittsburgh Sleep Quality Index (PSQI) |
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Inclusion Criteria:
Subjects for this study will meet the following criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wang Xin, MD | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital, Beijing, China | Beijing | Beijing Municipality | 100032 | China | ||
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| placebo of wuling capsule |
| Drug |
orally, three tablets each time and three times a day |
|
| 3 months |
| the quality of life using Quality of Life in Epilepsy (QOLIE-31) | 3 months |
| the Second Affiliated Hospital of Guangzhou Medical College, Guangzhou, China |
| Guangzhou |
| Guangdong |
| 510260 |
| China |
| Shanghai Fifth People's Hospital | Shanghai | Shanghai Municipality | 100050 | China |
| Department of Neurology, Zhongshan Hospital, Fudan University, Shanghai, China | Shanghai | Shanghai Municipality | 200032 | China |
| Department of Neurology, Huashan Hospital, Fudan University, Shanghai, China | Shanghai | Shanghai Municipality | 200040 | China |
| Department of Neurology, Renji Hospital, Shanghai Jiaotong University, Shanghai, China | Shanghai | Shanghai Municipality | 200127 | China |
| the Sixth People's Hospital of Shanghai Jiaotong University,Shanghai,China | Shanghai | Shanghai Municipality | 200233 | China |
| Department of Neurology, Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310009 | China |
| the First Municipal Hospital of Guangzhou | Guangzhou | China |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C533472 | wuling |
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