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

 Subjects for this study will meet the following criteria:

 1. Age greater than or equal to 18 years.

 2. 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.

 3. Score of a 17 item Hamilton Depression is greater than or equal to 17 and depressive
 symptoms have lasted for at least 2 weeks.

 4. Haven't taken any anti-anxiety, anti-depressant and anti-psychotic drugs in recent 2
 weeks.

 5. Must sign the informed consent form.

 Exclusion Criteria:

 1. Now accepting or have accepted other drugs clinical trial in the last month.

 2. History of serious psychiatric illness other than depression.

 3. Having suicide ideas or suicide behaviors.

 4. Progressive illness of central nervous system, such as degenerative disease or tumor.

 5. History of serious cardiac or pulmonary disease, hepatic and renal dysfunction, and
 malignant tumors.

 6. 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.

 7. During pregnant or lactation period.

 8. The person who is disabled or mentally disabled.