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A Registration Study on Depression in Patients With Epilepsy

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ClinicalTrials.gov Identifier: NCT03247764
Recruitment Status : Not yet recruiting
First Posted : August 14, 2017
Last Update Posted : August 14, 2017
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

Brief Summary:
The prevalence of comorbid depression in patients with epilepsy is as high as 30-50%. The depressive symptoms severely affect seizure severity and quality of life in patients with epilepsy. The aim of this study is to register the diagnosis and treatment for depression in patients with epilepsy from the East China, determining the incidence rate of comorbid depression in patients with epilepsy and the choices for the antidepressant treatment. At the same time, neuroimaging data such as brain MRI and blood sample will be collected to analyze some biomarkers for the comorbidity of epilepsy and depression.

Condition or disease Intervention/treatment
Epilepsy Depression Drug: SSRIs or xylaria nigripes

Study Type : Observational [Patient Registry]
Estimated Enrollment : 1200 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: A Registration Study on Diagnosis and Treatment for Comorbid Depression in Patients With Epilepsy From the East China
Estimated Study Start Date : October 8, 2017
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Group/Cohort Intervention/treatment
patients with epilepsy and depression
Patients with comorbidity of epilepsy and depression will be asked to use antidepressants such as selective serotonin reuptake inhibitor(SSRIs) or xylaria nigripes and followed up
Drug: SSRIs or xylaria nigripes
Patients with comorbidity of epilepsy and depression will be used SSRIs or xylaria nigripes as antidepressants after discussing with them. They will still be followed up if they don't want to use any antidepressants.




Primary Outcome Measures :
  1. Comparing the efficacy of using SSRIs with using xylaria nigripes on depressive symptoms in patients with epilepsy and depression [ Time Frame: 6 month ]
    The reduction rate of Hamilton Depression Rating Scale (HAMD) score will be used to assess the change of depressive symptoms

  2. The safety of using SSRIs and xylaria nigripes in patients with epilepsy [ Time Frame: 6 month ]
    The changes of seizure frequencies will be assessed


Secondary Outcome Measures :
  1. The rate of antidepressant treatment in patients with comorbidity of epilepsy and depression [ Time Frame: 6 month ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients with epilepsy who meet the inclusion and exclusion criteria will be asked to fill out PHQ-9 scale to screen depression
Criteria

Inclusion Criteria:

  • At least 1 or more seizures with evidences demonstrated by EEG

Exclusion Criteria:

  • Severe psychotic symptoms such as hallucination and delusions
  • Progressive central nervous system diseases such as acute stroke, brain malignant tumors, encephalitis, and Parkinson's disease etc.
  • Severe cardiac, pulmonary, hepatic, and renal diseases
  • Severe cognitive dysfunctions and physical disabilities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03247764


Contacts
Contact: Weifeng Peng, MD 8602164041990 ext 2976 peng.weifeng@zs-hospital.sh.cn

Sponsors and Collaborators
Shanghai Zhongshan Hospital

Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT03247764     History of Changes
Other Study ID Numbers: Regist-EP and DP
First Posted: August 14, 2017    Key Record Dates
Last Update Posted: August 14, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Depression
Depressive Disorder
Epilepsy
Behavioral Symptoms
Mood Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases