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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04517058
Enrollment
300
Registered
2020-08-18
Start date
2021-11-24
Completion date
2023-12-31
Last updated
2021-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

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.

Sponsors

Huashan Hospital
CollaboratorOTHER
Ruijin Hospital
CollaboratorOTHER
Shanghai 10th People's Hospital
CollaboratorOTHER
Shanghai 6th People's Hospital
CollaboratorOTHER
Shanghai East Hospital
CollaboratorOTHER
Shanghai Zhongshan Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
the rate of seizure frequency12 monthsepilepsy diary

Secondary

MeasureTime frameDescription
the quality of life12 monthsscale

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026