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

• Conditions: Epilepsy
• Interventions: Other: psychology therapy

• Registration Number: NCT04517058
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

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.

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 Timeline

• Study First Submitted: 2020-08-15
• Study First Submitted QC: 2020-08-17
• Study First Posted: 2020-08-18
• Status Verified: 2021-11
• Study Start: 2021-11-24
• Last Update Submitted: 2021-12-19
• Last Update Posted: 2021-12-28
• Primary Completion: 2023-09-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
epilepsy patients with depression group	psychology therapy	the score of HAMD-17\>7

Primary Outcome Measures

Name	Time	Method
the rate of seizure frequency	12 months	epilepsy diary

Secondary Outcome Measures

Name	Time	Method
the quality of life	12 months	scale

Trial Locations

Locations (1)

Department of Neurology, Zhongshan Hospital, Fudan University, Shanghai, China; 🇨🇳 Shanghai, Shanghai, China