Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT04517058
Status:
UNKNOWN
Last Update Posted:
2021-12-28
First Post:
2020-08-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Prospective Cohort Study on the Comorbid Depression in Patients With Newly-diagnosed Epilepsy
Sponsor:
Shanghai Zhongshan Hospital
Organization:
Study Overview
Official Title:
The Influence of Comorbid Depression on the Prognosis of Patients With Newly-Diagnosed Epilepsy: A Prospective, Multi-center, Cohort Study
Status:
UNKNOWN
Status Verified Date:
2021-11
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: