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

NCT ID: NCT04517058

Last Updated: 2021-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-24

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Epilepsy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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epilepsy patients with depression group

the score of HAMD-17\>7

psychology therapy

Intervention Type OTHER

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.

epilepsy patients without depression group

the score of HAMD-17≤7

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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SSRIs antidepressant drugs

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Huashan Hospital

OTHER

Sponsor Role collaborator

Ruijin Hospital

OTHER

Sponsor Role collaborator

Shanghai 10th People's Hospital

OTHER

Sponsor Role collaborator

Shanghai 6th People's Hospital

OTHER

Sponsor Role collaborator

Shanghai East Hospital

OTHER

Sponsor Role collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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NEWEpiDp

Identifier Type: -

Identifier Source: org_study_id