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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2013-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Epilepsy Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Wuling capsule

Group Type EXPERIMENTAL

wuling capsule

Intervention Type DRUG

orally, three tablets each time,three times a day

Placebo

Group Type PLACEBO_COMPARATOR

placebo of wuling capsule

Intervention Type DRUG

orally, three tablets each time and three times a day

Interventions

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wuling capsule

orally, three tablets each time,three times a day

Intervention Type DRUG

placebo of wuling capsule

orally, three tablets each time and three times a day

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No