EpilepsyNCT03247764
A Registration Study on Depression in Patients With Epilepsy
An observational study of Epilepsy and Depression, run by Shanghai Zhongshan Hospital at 7 sites in China.
Trial summary
The aim of this study is to register the drug treatment of depression in patients with epilepsy in East China. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Epilepsy, Depression
- How many people
- 320 participants
- Where
- 7 sitesChina
- Study dates
- 1 Feb 2018to 31 Jan 2022
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with the comorbidity of epilepsy and depression present to the neurology department at 8 tertiary hospitals in East China
The inclusion criteria were as follows: (1) age 18-75, no gender limited; (2) diagnosis of epilepsy according to the definition by ILAE in 2014; (3) the score of 17-item Hamilton Depression Rating Scale greater than 7; (4) Obtaining informed consent of participants. The exclusion criteria were any of the following: (1) having psychiatric symptoms such as hallucination or delusion; (2) progressive neurological diseases and malignant tumors; (3) severe cognitive dysfunction (the score of MMSE less than 10).
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
Department of Neurology, Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Meiping Ding, MD, 86-0571-87783777
- Recruiting
Anhui Provincial Hospital
Hefei
Ruobin Qian
- Recruiting
Nanjing Brain Hospital
Nanjing
Xiaoshan Wang
- Recruiting
Department of Neurology, Huashan Hospital, Fudan University, Shanghai, China
Shanghai, Shanghai Municipality, 200040
Zhen Hong, MD, 86-021-52889999
- Recruiting
Shanghai General Hospital
Shanghai
Ming Zhu
- Recruiting
The Second Affiliated Hospital of Suzhou University
Suzhou
Chunfeng Liu
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou
Huiqin Xu
About this study
Official title: A Registration Study on Drug Treatment for Comorbid Depression in Patients With Epilepsy in East China
The aim of this study is to register the drug treatment of depression in patients with epilepsy in East China.
Read the detailed description
As the treatment rate for depression in epilepsy is unclear and the discordant voice of choosing antidepressants for most doctors, this prospective observational cohort study was designed to better understand the current situation of drug treatments in patients with the comorbidity of epilepsy and depression in East China. The secondary outcome was to investigate whether baseline depressive symptoms had an influence on seizure-control in patients with epilepsy at follow-up.
- Conditions
- Epilepsy, Depression
- Keywords
- epilepsy, depression, drug treatment
- Medical subject headings
- Epilepsy, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
observational study
| Study group | Role | What they receive |
|---|---|---|
| patients with the comorbidity of epilepsy and depression | the clinical data, psychological assessment, and drug treatments will be investigated in patients with the comorbidity of epilepsy and depression |
What is being measured
The primary outcome is the main question the study is designed to answer.
the drug treatment rate of depression in patients with epilepsy
the drug treatment rate at baseline and 6 months at follow-up
Measured: 6 months
Secondary outcomes (1)
the influence of depression on seizure-control
whether depression at baseline affects seizure-control 6 months later
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2017
- Study start1 Feb 2018
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Jan 2022 (estimated)
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 320 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xin Wang, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03247764
- Sponsor's protocol ID
- Regist-EP and DP
- Status last verified
- Dec 2021
- First submitted
- 3 Aug 2017
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Registration Study on Drug Treatment for Comorbid Depression in Patients With Epilepsy in East China
- ClinicalTrials.gov ID
- NCT03247764
- Acronym / sponsor ID
- Regist-EP and DP
- Conditions
- Epilepsy, Depression
- Keywords
- epilepsy, depression, drug treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 14 Aug 2017 (actual)
- 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 aim of this study is to register the drug treatment of depression in patients with epilepsy in East China.
Detailed description
As the treatment rate for depression in epilepsy is unclear and the discordant voice of choosing antidepressants for most doctors, this prospective observational cohort study was designed to better understand the current situation of drug treatments in patients with the comorbidity of epilepsy and depression in East China. The secondary outcome was to investigate whether baseline depressive symptoms had an influence on seizure-control in patients with epilepsy at follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with the comorbidity of epilepsy and depression | – | –the clinical data, psychological assessment, and drug treatments will be investigated in patients with the comorbidity of epilepsy and depression |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with the comorbidity of epilepsy and depression present to the neurology department at 8 tertiary hospitals in East China
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 |
|---|---|---|
| observational study | Other | patients with the comorbidity of epilepsy and depression |
Primary outcome
the drug treatment rate of depression in patients with epilepsy
Time frame: 6 months
the drug treatment rate at baseline and 6 months at follow-up
1 secondary outcome
the influence of depression on seizure-control
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
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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.
Xin Wang, PhD principal investigator
Fudan University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy and Depression, run by Shanghai Zhongshan Hospital at 7 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?
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: status not confirmed, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weifeng Peng, MD (862164041990 ext. 2976, peng.weifeng@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the drug treatment rate of depression in patients with epilepsy (time frame: 6 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 11 Jan 2022.