NCT01125241

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2010

Typical duration for not_applicable

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2010

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 18, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

September 17, 2014

Status Verified

September 1, 2014

Enrollment Period

2.9 years

First QC Date

April 26, 2010

Last Update Submit

September 16, 2014

Conditions

EpilepsyDepression

Keywords

wuling capsuleepilepsydepressionsuperiority clinical research

Outcome Measures

Primary Outcomes (1)

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

    3 months

Secondary Outcomes (4)

  • 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

Study Arms (2)

Wuling capsule

EXPERIMENTAL
Drug: wuling capsule

Placebo

PLACEBO COMPARATOR
Drug: placebo of wuling capsule

Interventions

wuling capsuleDRUG

orally, three tablets each time,three times a day

Wuling capsule
placebo of wuling capsuleDRUG

orally, three tablets each time and three times a day

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Peking Union Medical College Hospital, Beijing, China

Beijing, Beijing Municipality, 100032, China

Location

the Second Affiliated Hospital of Guangzhou Medical College, Guangzhou, China

Guangzhou, Guangdong, 510260, China

Location

Shanghai Fifth People's Hospital

Shanghai, Shanghai Municipality, 100050, China

Location

Department of Neurology, Zhongshan Hospital, Fudan University, Shanghai, China

Shanghai, Shanghai Municipality, 200032, China

Location

Department of Neurology, Huashan Hospital, Fudan University, Shanghai, China

Shanghai, Shanghai Municipality, 200040, China

Location

Department of Neurology, Renji Hospital, Shanghai Jiaotong University, Shanghai, China

Shanghai, Shanghai Municipality, 200127, China

Location

the Sixth People's Hospital of Shanghai Jiaotong University，Shanghai,China

Shanghai, Shanghai Municipality, 200233, China

Location

Department of Neurology, Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

the First Municipal Hospital of Guangzhou

Guangzhou, China

Location

MeSH Terms

Conditions

EpilepsyDepression

Interventions

wuling

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesBehavioral SymptomsBehavior

Study Officials

  • Wang Xin, MD

    Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
neurology department

Study Record Dates

First Submitted

April 26, 2010

First Posted

May 18, 2010

Study Start

September 1, 2010

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

September 17, 2014

Record last verified: 2014-09

Locations

CN(9)