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Characterization of Microbial, Immune and Epigenetic Biomarkers for Major Depressive Disorder and ECT Treatment

NCT03703414 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2018-10-16

No results posted yet for this study

Summary

The investigators aim to characterize fecal microbial biomarkers as well as blood cytokine levels in MDD patients vs. healthy controls. 40 MDD patients will be recruited for this study, as well as 20 healthy age-matched participants (as a control group). Following signing of informed consent, stool and blood (20 ml) samples will be collected from all participants, for microbial composition assessment, and blood measures of inflammation and protein expression. According to clinical assessment of the diagnosed MDD patients, the psychiatrist will recommend SSRI or ECT treatment, and the patients will be divided accordingly to treatment group. Clinical status will be assessed by the Hamilton Depression Rating Scale (HAM-D) scored by a psychiatrist at the starting point (before treatment), after 4 weeks of treatment (as ECT-group patients receive 8-12 treatments on average). A lowering in the HAM-D score will be considered clinical improvement which may be attributed to treatment. The investigators expect a treatment success rate of over 50% for ECT according to past experience. Blood and stool samples will be collected from MDD patients after 4 weeks of treatment, repeating inflammatory, protein expression and microbial measurements and comparing them to initial results. Additional data recorded will include age, BMI, ethnicity, previous medication use, and number of ECT treatments or current medication.

Conditions

Interventions

DIAGNOSTIC_TEST

Fecal microbiota composition analysis and blood cytokine level analysis

Fecal microbiota composition analysis and blood cytokine level analysis

Sponsors & Collaborators

  • Ziv Hospital

    lead OTHER_GOV

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2019-10-31
Completion
2019-10-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03703414 on ClinicalTrials.gov