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

2014-08-27 03:13:39 | BioPortfolio

Summary

The main purpose of this study is to determine the effects of add-on therapy of wuling capsule on depressive symptoms in epileptic patients with depression, to evaluate its influence on the frequency and severity of seizures, and to observe its effects on patients' sleeping condition, quality of life, and the level of serum antiepileptic drugs.

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. 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 epileptic patients with depression, to evaluate its influence on the frequency and severity of seizures, and to observe its effects on patients' sleeping condition, quality of life, and the level of serum antiepileptic drugs.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Epilepsy

Intervention

wuling capsule, placebo of wuling capsule

Location

Peking Union Medical College Hospital, Beijing, China
Beijing
Beijing
China
100032

Status

Not yet recruiting

Source

Shanghai Zhongshan Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:39-0400

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