A Registration Study on Depression in Patients With Epilepsy | NCT03247764

Studies
A Registration Study on Depression in Patients With Epilepsy

NCT03247764

Sponsor

Shanghai Zhongshan Hospital

Status

Unknown status

Last Update Posted

Jan 11, 2022Actual

Enrollment

320Estimated

Phase

Not provided

Conditions

Epilepsy
Depression

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2018Actual

Primary Completion Date

Dec 31, 2021Estimated

Completion Date

Jan 31, 2022Estimated

First Submitted Date

Aug 3, 2017

First Submission Date that Met QC Criteria

Aug 8, 2017

First Posted Date

Aug 14, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 19, 2021

Last Update Posted Date

Jan 11, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

320Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
	Other	observational study	patients with the comorbidity of epilepsy and depression

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
the influence of depression on seizure-control	whether depression at baseline affects seizure-control 6 months later	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

patients with the comorbidity of epilepsy and depression present to the neurology department at 8 tertiary hospitals in East China

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Weifeng Peng, MD	Contact	862164041990	2976	peng.weifeng@zs-hospital.sh.cn

Overall Officials

Name	Affiliation	Role
Xin Wang, PhD	Fudan University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Neurology, Huashan Hospital, Fudan University, Shanghai, China	Recruiting	Shanghai	Shanghai Municipality	200040	China

Condition Browse Module

MeSH Terms

ID	Term
D004827	Epilepsy
D003863	Depression

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D001526	Behavioral Symptoms

Browse Leaves

Not provided

Browse Branches

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