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

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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Epilepsy
• Intervention / Treatment: Drug: wuling capsule; Drug: placebo of wuling capsule

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.

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangzhou, China
    • The First Municipal Hospital of Guangzhou
  • Beijing
    • Beijing, Beijing, China, 100032
      • Peking Union Medical College Hospital, Beijing, China
  • Guangdong
    • Guangzhou, Guangdong, China, 510260
      • the Second Affiliated Hospital of Guangzhou Medical College, Guangzhou, China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Department of Neurology, Zhongshan Hospital, Fudan University, Shanghai, China
    • Shanghai, Shanghai, China, 100050
      • Shanghai Fifth People's Hospital
    • Shanghai, Shanghai, China, 200040
      • Department of Neurology, Huashan Hospital, Fudan University, Shanghai, China
    • Shanghai, Shanghai, China, 200127
      • Department of Neurology, Renji Hospital, Shanghai Jiaotong University, Shanghai, China
    • Shanghai, Shanghai, China, 200233
      • the Sixth People's Hospital of Shanghai Jiaotong University，Shanghai,China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Department of Neurology, Second Affiliated Hospital of Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: placebo of wuling capsule; orally, three tablets each time and three times a day
EXPERIMENTAL: Wuling capsule	Drug: wuling capsule; orally, three tablets each time,three times a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
symptoms of depression using the 17-item Hamilton Depression Rating Scale (HDRS)	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
the frequency of seizures using diary	3 months
the severity of seizures using the National Hospital Seizure Severity Scale(NHS3)	3 months
the sleeping condition using Pittsburgh Sleep Quality Index (PSQI)	3 months
the quality of life using Quality of Life in Epilepsy (QOLIE-31)	3 months

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Collaborators: Shanghai Wu Mengchao Medical Foundation; Shanghai Ankang Pharmaceutical Co.,LTD
• Investigators: Principal Investigator: Wang Xin, MD, Fudan University

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (ACTUAL): August 1, 2013
• Study Completion (ACTUAL): August 1, 2013

Study Registration Dates

• First Submitted: April 26, 2010
• First Submitted That Met QC Criteria: May 15, 2010
• First Posted (ESTIMATE): May 18, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): September 17, 2014
• Last Update Submitted That Met QC Criteria: September 16, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: depression; epilepsy; wuling capsule; superiority clinical research
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mood Disorders; Epilepsy; Depression; Depressive Disorder
• Other Study ID Numbers: WL-2010