Clinical trial NCT04517058: A Prospective Cohort Study on the Comorbid Depression in Patients With Newly-diagnosed Epilepsy
Official title: The Influence of Comorbid Depression on the Prognosis of Patients With Newly-Diagnosed Epilepsy: A Prospective, Multi-center, Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epilepsy
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
Collaborators: name: Huashan Hospital
name: Ruijin Hospital
name: Shanghai 10th People's Hospital
name: Shanghai 6th People's Hospital
name: Shanghai East Hospital
First posted: 2020-08-18
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: newly-diagnosed epilepsy

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.

Eligibility criteria: 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

Primary outcomes:
measure: the rate of seizure frequency
timeFrame: 12 months
Secondary outcomes:
measure: the quality of life
timeFrame: 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Neurology, Zhongshan Hospital, Fudan University, Shanghai, China
state: Shanghai
Study officials:
References: