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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03247764
Other study ID # Regist-EP and DP
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 1, 2018
Est. completion date January 31, 2022

Study information

Verified date December 2021
Source Shanghai Zhongshan Hospital
Contact Weifeng Peng, MD
Phone 862164041990
Email peng.weifeng@zs-hospital.sh.cn
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The aim of this study is to register the drug treatment of depression in patients with epilepsy in East China.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 320
Est. completion date January 31, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Department of Neurology, Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang
China Anhui Provincial Hospital Hefei
China Nanjing Brain Hospital Nanjing
China Department of Neurology, Huashan Hospital, Fudan University, Shanghai, China Shanghai Shanghai
China Shanghai General Hospital Shanghai
China The Second Affiliated Hospital of Suzhou University Suzhou
China The First Affiliated Hospital of Wenzhou Medical University Wenzhou

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary the drug treatment rate of depression in patients with epilepsy the drug treatment rate at baseline and 6 months at follow-up 6 months
Secondary the influence of depression on seizure-control whether depression at baseline affects seizure-control 6 months later 6 months
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