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

NCT ID: NCT01681407

Last Updated: 2015-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

17 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2014-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Depression

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Depressed Patients

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

No interventions assigned to this group

Non-Depressed Controls

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

No interventions assigned to this group

Patients Relatives

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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HaEmek Medical Center, Israel

OTHER

Sponsor Role lead

Responsible Party

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Amichai Hareven

Dr Amichai Hareven

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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HaEmek Medical Center

Afula, , Israel

Site Status

Countries

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Israel

Other Identifiers

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EMC-07411-CTIL

Identifier Type: -

Identifier Source: org_study_id

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