Characterization of Microbial, Immune and Epigenetic Biomarkers for Major Depressive Disorder and ECT Treatment
1 other identifier
observational
60
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2018
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 9, 2018
CompletedFirst Posted
Study publicly available on registry
October 12, 2018
CompletedStudy Start
First participant enrolled
November 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2019
CompletedOctober 16, 2018
October 1, 2018
12 months
October 9, 2018
October 11, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
Correlation between MDD and fecal microbial communities (as determined by NGS sequencing) and as well as immune components (cytokine levels in blood)
4 week followup
Correlation between ECT treatment and fecal microbial communities (as determined by NGS) as well as blood cytokines in MDD patients
4 week followup
Correlation between SSRI treatment and fecal microbial communities (as determined by NGS) as well as blood cytokines in MDD patients
4 week followup
Study Arms (3)
Control
Healthy controls
ECT
MDD patients receiving ECT treatment
SSRI
MDD patients receiving SSRI treatment
Interventions
Fecal microbiota composition analysis and blood cytokine level analysis
Eligibility Criteria
40 MDD patients will be recruited for this study, as well as 20 healthy age-matched participants (as a control group).
You may qualify if:
- Healthy controls
- MDD patients with stable depression clinically diagnosed by a psychiatrist according to the \*Hamilton Depression Scale.
- Ages 18-80
You may not qualify if:
- Patients receiving antibiotics in the past 3 months prior to sampling
- Patients suffering from chronic gastrointestinal diseases
- Patients with chronic diseases such as autoimmune or cancer
- Patients with psychiatric co-morbidities such as schizophrenia.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ziv Hospitallead
Biospecimen
We will obtain fecal samples and blood samples from participants
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2018
First Posted
October 12, 2018
Study Start
November 1, 2018
Primary Completion
October 31, 2019
Study Completion
October 31, 2019
Last Updated
October 16, 2018
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will not share