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

NCT04517058 | Unknown DMC

• 1 other identifier: NEWEpiDp
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

• the rate of seizure frequency

  epilepsy diary

  12 months

Secondary Outcomes (1)

• the quality of life

  12 months

Study Arms (2)

epilepsy patients with depression group

the score of HAMD-17\>7

Other: psychology therapy

epilepsy patients without depression group

the score of HAMD-17≤7

Interventions

psychology therapy 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.

Also known as: SSRIs antidepressant drugs

epilepsy patients with depression group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

newly-diagnosed epilepsy

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• Huashan Hospital: collaborator
• Ruijin Hospital: collaborator
• Shanghai 10th People's Hospital: collaborator
• Shanghai 6th People's Hospital: collaborator
• Shanghai East Hospital: collaborator

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2020
• First Posted: August 18, 2020
• Study Start: November 24, 2021
• Primary Completion: September 30, 2023
• Study Completion: December 31, 2023
• Last Updated: December 28, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)