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

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Zhongshan Hospital
• Collaborators: Shanghai Ankang Pharmaceutical Co.,LTD; Shanghai Wu Mengchao Medical Foundation

Criteria

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.