EpilepsyNCT01125241
A Study to Evaluate the Efficacy and Safety of Add-on Therapy of Wuling Capsule in Epilepsy Patients With Depression
A study testing wuling capsule in people with Epilepsy and Depression, run by Shanghai Zhongshan Hospital at 9 sites in China.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy, Depression
- What is being tested?
- wuling capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 9 sitesChina
- Study dates
- Sep 2010to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
Peking Union Medical College Hospital, Beijing, China
Beijing, Beijing Municipality, 100032
the Second Affiliated Hospital of Guangzhou Medical College, Guangzhou, China
Guangzhou, Guangdong, 510260
the First Municipal Hospital of Guangzhou
Guangzhou
Department of Neurology, Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Shanghai Fifth People's Hospital
Shanghai, Shanghai Municipality, 100050
Department of Neurology, Zhongshan Hospital, Fudan University, Shanghai, China
Shanghai, Shanghai Municipality, 200032
Department of Neurology, Huashan Hospital, Fudan University, Shanghai, China
Shanghai, Shanghai Municipality, 200040
Department of Neurology, Renji Hospital, Shanghai Jiaotong University, Shanghai, China
Shanghai, Shanghai Municipality, 200127
the Sixth People's Hospital of Shanghai Jiaotong University，Shanghai,China
Shanghai, Shanghai Municipality, 200233
About this study
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
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.
Read the 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.
- Conditions
- Epilepsy, Depression
- Being tested
- wuling capsule, placebo of wuling capsule
- Keywords
- wuling capsule, epilepsy, depression, superiority clinical research
- Medical subject headings
- Epilepsy, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wuling capsuleDrug
orally, three tablets each time,three times a day
placebo of wuling capsuleDrug
orally, three tablets each time and three times a day
| Study group | Role | What they receive |
|---|---|---|
| Wuling capsule | Experimental | Not described Receives: Drug: wuling capsule |
| Placebo | Placebo comparator | Not described Receives: Drug: placebo of wuling capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
symptoms of depression using the 17-item Hamilton Depression Rating Scale (HDRS)
Measured: 3 months
Secondary outcomes (4)
the frequency of seizures using diary
Measured: 3 months
the severity of seizures using the National Hospital Seizure Severity Scale(NHS3)
Measured: 3 months
the sleeping condition using Pittsburgh Sleep Quality Index (PSQI)
Measured: 3 months
the quality of life using Quality of Life in Epilepsy (QOLIE-31)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2010 (estimated)
- Study startSep 2010
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Wu Mengchao Medical Foundation, Shanghai Ankang Pharmaceutical Co.,LTD
- Responsible party
- Principal investigator, Weifeng Peng, Shanghai Zhongshan Hospital
- Investigators
- Wang Xin, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01125241
- Sponsor's protocol ID
- WL-2010
- Status last verified
- Sep 2014
- First submitted
- 26 Apr 2010
- Last updated
- 17 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01125241
- Acronym / sponsor ID
- WL-2010
- Conditions
- Epilepsy, Depression
- Keywords
- wuling capsule, epilepsy, depression, superiority clinical research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- Shanghai Wu Mengchao Medical Foundation, Shanghai Ankang Pharmaceutical Co.,LTD
- Study start
- Sep 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 18 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wuling capsule | Experimental | Drug: wuling capsule |
| Placebo | Placebo comparator | Drug: placebo of wuling capsule |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| wuling capsuleorally, three tablets each time,three times a day | Drug | Wuling capsule |
| placebo of wuling capsuleorally, three tablets each time and three times a day | Drug | Placebo |
Primary outcome
symptoms of depression using the 17-item Hamilton Depression Rating Scale (HDRS)
Time frame: 3 months
4 secondary outcomes
the frequency of seizures using diary
Time frame: 3 months
the severity of seizures using the National Hospital Seizure Severity Scale(NHS3)
Time frame: 3 months
the sleeping condition using Pittsburgh Sleep Quality Index (PSQI)
Time frame: 3 months
the quality of life using Quality of Life in Epilepsy (QOLIE-31)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wang Xin, MD principal investigator
Fudan University
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wuling capsule in people with Epilepsy and Depression, run by Shanghai Zhongshan Hospital at 9 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
symptoms of depression using the 17-item Hamilton Depression Rating Scale (HDRS) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2014.