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MIRPROT: Peripheral Plasma Micro-RNA and Proteomics Mapping in Depressive Patients, Treated With SSRI Medications

Sponsor
HaEmek Medical Center, Israel (Other)
Overall Status
Terminated
CT.gov ID
NCT01681407
Collaborator
(none)
17
Enrollment
1
Location
27
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A pilot study of mapping the peripheral plasma micro-RNA and proteomics patterns in depressive patients, treated with SSRI medications. It is an observational clinical bio-markers laboratory controlled research with no device.

The research includes two groups; one for patients diagnosed of having depression, and will get a standard SSRI medication regimen. Second group is for control subjects without depression. An option for a third group is planned to include first degree relatives of the depressed patients. After giving their informed consents, subjects and patients will go through standard clinical psychiatric interview, and routine clinical lab tests. Clinical standard, specific depression and anxiety questionnaires will be held at four follow-up meetings: at start; after 2 weeks; 4 weeks; and 10 weeks. Subjects and patients will be asked to give blood samples at these points of time for the lab processing: Complete plasma proteomics and specific micro-RNA levels.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    17 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Peripheral Plasma Micro-RNA and Proteomics Mapping in Depressive Patients, Treated With SSRI Medications.
    Study Start Date :
    Nov 1, 2011
    Actual Primary Completion Date :
    Jul 1, 2013
    Actual Study Completion Date :
    Feb 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    Depressed Patients

    Patients: Group of patients that are diagnosed for having depression, and are suitable for SSRI treatment.
    Non-Depressed Controls

    Controls: Volunteers that had clinical screening with no depression diagnosis.
    Patients Relatives

    Patient Relatives (Optional group for later stage): First degree relatives with no depression diagnosis.

    Outcome Measures

    Primary Outcome Measures

    1. Depressive symptoms remission or response rates, under usual SSRI treatment. [10 weeks of follow up]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Depressed patients,over 18 yo

    • Untreated with SSRI, in the last 3 months

    Exclusion Criteria:

    • Bipolar patients or another major psychopathology

    • Depressive disorder clearly due to general medical condition, or drug related

    • BMI under 18.5 or above 40

    • Pregnant patients

    • Active suicidality

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 HaEmek Medical Center Afula Israel

    Sponsors and Collaborators

    • HaEmek Medical Center, Israel

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Amichai Hareven, Dr Amichai Hareven, HaEmek Medical Center, Israel
    ClinicalTrials.gov Identifier:
    NCT01681407
    Other Study ID Numbers:
    • EMC-07411-CTIL
    First Posted:
    Sep 10, 2012
    Last Update Posted:
    Jun 19, 2015
    Last Verified:
    Jun 1, 2015
    Keywords provided by Amichai Hareven, Dr Amichai Hareven, HaEmek Medical Center, Israel
    Depression
    Selective Serotonin Reuptake Inhibitors
    MicroRNAs
    Proteome
    Additional relevant MeSH terms:
    Depression

    Study Results

    No Results Posted as of Jun 19, 2015