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

Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01125241
• Other study ID #: WL-2010
• Status: Completed
• Phase: N/A
• First received: April 26, 2010
• Last updated: September 16, 2014
• Start date: September 2010
• Est. completion date: August 2013

Study information

• Verified date: September 2014
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Epilepsy

Intervention

Drug:
• wuling capsule
orally, three tablets each time,three times a day
• placebo of wuling capsule
orally, three tablets each time and three times a day

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital	Shanghai Ankang Pharmaceutical Co.,LTD, Shanghai Wu Mengchao Medical Foundation

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	symptoms of depression using the 17-item Hamilton Depression Rating Scale (HDRS)		3 months	No
Secondary	the frequency of seizures using diary		3 months	Yes
Secondary	the severity of seizures using the National Hospital Seizure Severity Scale(NHS3)		3 months	Yes
Secondary	the sleeping condition using Pittsburgh Sleep Quality Index (PSQI)		3 months	No
Secondary	the quality of life using Quality of Life in Epilepsy (QOLIE-31)		3 months	No