A Study to Evaluate the Efficacy and Safety of Add-on Therapy of Wuling Capsule in Epilepsy Patients With Depression

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
A Study to Evaluate the Efficacy and Safety of Add-on Therapy of Wuling Capsule in Epilepsy Patients With Depression: a Muli-center, Randomized, Double-blinded, Placebo-controlled Superiority Clinical Trial

Conditions
-----------------
Epilepsy, Depression

Intervention / Treatment
-----------------
* Drug: wuling capsule
* Drug: placebo of wuling capsule


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects for this study will meet the following criteria: Age greater than or equal to 18 years. Must be in accordance with the diagnostic criteria of epilepsy and have taken antiepileptic drugs regularly at least for 6 months, which will not be changed recently. The duration to the latest seizure must be longer than 24 hours. Score of a 17 item Hamilton Depression is greater than or equal to 17 and depressive symptoms have lasted for at least 2 weeks. Haven't taken any anti-anxiety, anti-depressant and anti-psychotic drugs in recent 2 weeks. Must sign the informed consent form. Exclusion Criteria: Now accepting or have accepted other drugs clinical trial in the last month. History of serious psychiatric illness other than depression. Having suicide ideas or suicide behaviors. Progressive illness of central nervous system, such as degenerative disease or tumor. History of serious cardiac or pulmonary disease, hepatic and renal dysfunction, and malignant tumors. The value of ALT or AST is higher than 1.5 times normal range, or the number of white blood cells is less than 2500/ul, or the number of neutrophil granulocyte is less than 1000/ul. During pregnant or lactation period. The person who is disabled or mentally disabled.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wuling capsule<br> | Drug: wuling capsule<br>* orally, three tablets each time,three times a day<br>|
| Placebo Comparator: Placebo<br> | Drug: placebo of wuling capsule<br>* orally, three tablets each time and three times a day<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| symptoms of depression using the 17-item Hamilton Depression Rating Scale (HDRS) |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | 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) |  | 3 months | 
| the quality of life using Quality of Life in Epilepsy (QOLIE-31) |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
wuling capsule, epilepsy, depression, superiority clinical research