A Registration Study on Depression in Patients With Epilepsy

Depression Clinical Trial

Official title:

A Registration Study on Drug Treatment for Comorbid Depression in Patients With Epilepsy in East China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03247764
• Other study ID #: Regist-EP and DP
• Status: Recruiting
• 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
• 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).

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Epilepsy

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