A Prospective Cohort Study on the Comorbid Depression in Patients With Newly-diagnosed Epilepsy

The Influence of Comorbid Depression on the Prognosis of Patients With Newly-Diagnosed Epilepsy: A Prospective, Multi-center, Cohort Study

Epilepsy is a chronic brain disease with recurrent seizures and the comorbidity of psychiatric diseases are very common. The prevalence of depression in patients with refractory epilepsy is about 60%. However, the early diagnosis is usually difficult due to the unclear mechanism and untypical clinical symptoms, and there are no extremely effective treatments for depression in patients with epilepsy until now. In this prospective, multi-center, cohort study, we aim to investigate and screen two different types of depression ("cognitive" and "somatic") in patients with epilepsy by using the combination of regular moods evaluating scales and heart rate variability instrument. The intervening methods of combining transcranial direct current stimulation (tDCS) and serotonin re-uptake inhibitors (SSRIs) are used to treat the patients with comorbidity of epilepsy and depression.

Study Overview

• Status: Active, not recruiting
• Conditions: Epilepsy
• Intervention / Treatment: Other: psychology therapy

Detailed Description

Epilepsy is a chronic brain disease with recurrent seizures and the comorbidity of psychiatric diseases are very common. The prevalence of depression in patients with refractory epilepsy is about 60%. However, the early diagnosis is usually difficult due to the unclear mechanism and untypical clinical symptoms, and there are no extremely effective treatments for depression in patients with epilepsy until now. In this prospective, multi-center, cohort study, we aim to investigate and screen two different types of depression ("cognitive" and "somatic") in patients with epilepsy by using the combination of regular moods evaluating scales and heart rate variability instrument. The intervening methods of combining transcranial direct current stimulation (tDCS) and serotonin re-uptake inhibitors (SSRIs) are used to treat the patients with comorbidity of epilepsy and depression. And resting-state functional MRI will be conducted in patients with the comorbidity of epilepsy and depression before and after the combing treatment of tDCS and SSRIs.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Department of Neurology, Zhongshan Hospital, Fudan University, Shanghai, China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

newly-diagnosed epilepsy

Description

Inclusion Criteria:

• meeting the definition of epilepsy according to the new definition issued by ILAE in 2014
• not using antidepressants
• acquiring informed consents

Exclusion Criteria:

• patients with severe psychiatric symptoms;
• progressive brain diseases
• malignant tumors
• severe cognitive declines

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
epilepsy patients with depression group; the score of HAMD-17>7	Other: psychology therapy; If the symptoms are mild, patients will get the psychology therapy. If it's necessary according to patients' willings, patients will be given SSRIs antidepressant therapy.; Other Names: SSRIs antidepressant drugs
epilepsy patients without depression group; the score of HAMD-17≤7

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the rate of seizure frequency	epilepsy diary	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the quality of life	scale	12 months

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Collaborators: Huashan Hospital; Shanghai 10th People's Hospital; Ruijin Hospital; Shanghai East Hospital; Shanghai 6th People's Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 24, 2021
• Primary Completion (ANTICIPATED): September 30, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: August 15, 2020
• First Submitted That Met QC Criteria: August 17, 2020
• First Posted (ACTUAL): August 18, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 28, 2021
• Last Update Submitted That Met QC Criteria: December 19, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Psychotropic Drugs; Antidepressive Agents
• Other Study ID Numbers: NEWEpiDp

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No