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

Depression Clinical Trial

— MIRPROT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01681407
• Other study ID #: EMC-07411-CTIL
• Status: Terminated
• Phase: N/A
• First received: September 5, 2012
• Last updated: June 18, 2015
• Start date: November 2011
• Est. completion date: February 2014

Study information

• Verified date: June 2015
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: February 2014
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Depression

Locations

Country	Name	City	State
Israel	HaEmek Medical Center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depressive symptoms remission or response rates, under usual SSRI treatment.		10 weeks of follow up	No