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

NCT01681407 | Terminated DMC

• 1 other identifier: EMC-07411-CTIL
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

Depression; Selective Serotonin Reuptake Inhibitors; MicroRNAs; Proteome

Outcome Measures

Primary Outcomes (1)

• Depressive symptoms remission or response rates, under usual SSRI treatment.

  10 weeks of follow up

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients at community or hospital settings. Patients were clinically evaluated for suspected depression.

You may qualify if:

• Depressed patients,over 18 yo
• Untreated with SSRI, in the last 3 months

You may not qualify if:

• 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

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (1)

HaEmek Medical Center

Afula, Israel

Location

Biospecimen

Retention: SAMPLES WITH DNA

Subjects and patients will be asked to give blood samples at 4 points of time for the lab processing: micro-RNA and proteome profiling/

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Amichai Hareven

Study Record Dates

• First Submitted: September 5, 2012
• First Posted: September 10, 2012
• Study Start: November 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: February 1, 2014
• Last Updated: June 19, 2015

Record last verified: 2015-06

Locations

IL (1)