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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Shanghai Zhongshan Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Shanghai Wu Mengchao Medical Foundation
Shanghai Ankang Pharmaceutical Co.,LTD
Information provided by (Responsible Party):
Weifeng Peng, Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier:
NCT01125241
First received: April 26, 2010
Last updated: April 24, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Epilepsy
Depression
Drug: wuling capsule
Drug: placebo of wuling capsule

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

Resource links provided by NLM:


Further study details as provided by Shanghai Zhongshan Hospital:

Primary Outcome Measures:
  • symptoms of depression using the 17-item Hamilton Depression Rating Scale (HDRS) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the frequency of seizures using diary [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • the severity of seizures using the National Hospital Seizure Severity Scale(NHS3) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • the sleeping condition using Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • the quality of life using Quality of Life in Epilepsy (QOLIE-31) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 230
Study Start Date: September 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Wuling capsule Drug: wuling capsule
orally, three tablets each time,three times a day
Placebo Comparator: Placebo Drug: placebo of wuling capsule
orally, three tablets each time and three times a day

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. 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects for this study will meet the following criteria:

  1. Age 18 to 70 years.
  2. Must be in accordance with the diagnostic criteria of epilepsy and have taken antiepileptic drugs regularly at least for 3 months, which will not be changed recently. The frequency of seizures was less than 6 times in recent 3 months and 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 or psychiatric epileptic seizures.
  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01125241

Contacts
Contact: Peng Weifeng, MS 86-021-64041990 ext 2971 peng.weifeng@zs-hospital.sh.cn

Locations
China, Beijing
Peking Union Medical College Hospital, Beijing, China Recruiting
Beijing, Beijing, China, 100032
Contact: Wu Liwen, MD    010-65296114      
China, Guangdong
the Second Affiliated Hospital of Guangzhou Medical College, Guangzhou, China Recruiting
Guangzhou, Guangdong, China, 510260
Contact: Liao Weiping, MD    86-020-34152299      
China, Shanghai
Department of Neurology, Zhongshan Hospital, Fudan University, Shanghai, China Recruiting
Shanghai, Shanghai, China, 200032
Contact: Peng Weifeng, MS    86-021-64041990 ext 2971    peng.weifeng@zs-hospital.sh.cn   
Principal Investigator: Wang Xin, MD         
Department of Neurology, Huashan Hospital, Fudan University, Shanghai, China Recruiting
Shanghai, Shanghai, China, 200040
Contact: Hong Zhen, MD    86-021-52889999      
Department of Neurology, Renji Hospital, Shanghai Jiaotong University, Shanghai, China Active, not recruiting
Shanghai, Shanghai, China, 200127
Shanghai Fifth People's Hospital Recruiting
Shanghai, Shanghai, China, 100050
Contact: Ren Chuancheng, MD    86-010-66112251      
the Sixth People's Hospital of Shanghai Jiaotong University,Shanghai,China Active, not recruiting
Shanghai, Shanghai, China, 200233
China, Zhejiang
Department of Neurology, Second Affiliated Hospital of Zhejiang University School of Medicine Recruiting
Hangzhou, Zhejiang, China, 310009
Contact: Ding Meiping, MD    86-0571-87783777      
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Shanghai Wu Mengchao Medical Foundation
Shanghai Ankang Pharmaceutical Co.,LTD
Investigators
Principal Investigator: Wang Xin, MD Fudan University
  More Information

No publications provided

Responsible Party: Weifeng Peng, neurology department, Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT01125241     History of Changes
Other Study ID Numbers: WL-2010
Study First Received: April 26, 2010
Last Updated: April 24, 2012
Health Authority: China: Ethics Committee

Keywords provided by Shanghai Zhongshan Hospital:
wuling capsule
epilepsy
depression
superiority clinical research

Additional relevant MeSH terms:
Depression
Depressive Disorder
Epilepsy
Behavioral Symptoms
Mood Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 28, 2014