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

Primary Purpose

Epilepsy, Depression

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
wuling capsule
placebo of wuling capsule
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring wuling capsule, epilepsy, depression, superiority clinical research

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Peking Union Medical College Hospital, Beijing, China
  • the Second Affiliated Hospital of Guangzhou Medical College, Guangzhou, China
  • Shanghai Fifth People's Hospital
  • Department of Neurology, Zhongshan Hospital, Fudan University, Shanghai, China
  • Department of Neurology, Huashan Hospital, Fudan University, Shanghai, China
  • Department of Neurology, Renji Hospital, Shanghai Jiaotong University, Shanghai, China
  • the Sixth People's Hospital of Shanghai Jiaotong University，Shanghai,China
  • Department of Neurology, Second Affiliated Hospital of Zhejiang University School of Medicine
  • the First Municipal Hospital of Guangzhou

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Wuling capsule

Placebo

Arm Description

Outcomes

Primary Outcome Measures

symptoms of depression using the 17-item Hamilton Depression Rating Scale (HDRS)

Secondary Outcome Measures

the frequency of seizures using diary
the severity of seizures using the National Hospital Seizure Severity Scale(NHS3)
the sleeping condition using Pittsburgh Sleep Quality Index (PSQI)
the quality of life using Quality of Life in Epilepsy (QOLIE-31)

Full Information

First Posted
April 26, 2010
Last Updated
September 16, 2014
Sponsor
Shanghai Zhongshan Hospital
Collaborators
Shanghai Wu Mengchao Medical Foundation, Shanghai Ankang Pharmaceutical Co.,LTD
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1. Study Identification

Unique Protocol Identification Number
NCT01125241
Brief Title
A Study to Evaluate the Efficacy and Safety of Add-on Therapy of Wuling Capsule in Epilepsy Patients With Depression
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Zhongshan Hospital
Collaborators
Shanghai Wu Mengchao Medical Foundation, Shanghai Ankang Pharmaceutical Co.,LTD

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Depression
Keywords
wuling capsule, epilepsy, depression, superiority clinical research

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wuling capsule
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
wuling capsule
Intervention Description
orally, three tablets each time,three times a day
Intervention Type
Drug
Intervention Name(s)
placebo of wuling capsule
Intervention Description
orally, three tablets each time and three times a day
Primary Outcome Measure Information:
Title
symptoms of depression using the 17-item Hamilton Depression Rating Scale (HDRS)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
the frequency of seizures using diary
Time Frame
3 months
Title
the severity of seizures using the National Hospital Seizure Severity Scale(NHS3)
Time Frame
3 months
Title
the sleeping condition using Pittsburgh Sleep Quality Index (PSQI)
Time Frame
3 months
Title
the quality of life using Quality of Life in Epilepsy (QOLIE-31)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wang Xin, MD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital, Beijing, China
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100032
Country
China
Facility Name
the Second Affiliated Hospital of Guangzhou Medical College, Guangzhou, China
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510260
Country
China
Facility Name
Shanghai Fifth People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
100050
Country
China
Facility Name
Department of Neurology, Zhongshan Hospital, Fudan University, Shanghai, China
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Department of Neurology, Huashan Hospital, Fudan University, Shanghai, China
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Department of Neurology, Renji Hospital, Shanghai Jiaotong University, Shanghai, China
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Facility Name
the Sixth People's Hospital of Shanghai Jiaotong University，Shanghai,China
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200233
Country
China
Facility Name
Department of Neurology, Second Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Facility Name
the First Municipal Hospital of Guangzhou
City
Guangzhou
Country
China

12. IPD Sharing Statement

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

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