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

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04517058
• Other study ID #: NEWEpiDp
• Status: Active, not recruiting
• Start date: November 24, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2021
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: December 31, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy

Intervention

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.

Locations

Country	Name	City	State
China	Department of Neurology, Zhongshan Hospital, Fudan University, Shanghai, China	Shanghai	Shanghai

Sponsors (6)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital	Huashan Hospital, Ruijin Hospital, Shanghai 10th People's Hospital, Shanghai 6th People's Hospital, Shanghai East Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the rate of seizure frequency	epilepsy diary	12 months
Secondary	the quality of life	scale	12 months