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

This study is currently recruiting participants.
Verified January 2013 by HaEmek Medical Center, Israel
Sponsor:
Information provided by (Responsible Party):
Amichai Hareven, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT01681407
First received: September 5, 2012
Last updated: January 31, 2013
Last verified: January 2013
  Purpose

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
Depression

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Peripheral Plasma Micro-RNA and Proteomics Mapping in Depressive Patients, Treated With SSRI Medications.

Resource links provided by NLM:


Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • Depressive symptoms remission or response rates, under usual SSRI treatment. [ Time Frame: 10 weeks of follow up ] [ Designated as safety issue: No ]

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/


Estimated Enrollment: 40
Study Start Date: November 2011
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01681407

Contacts
Contact: Amichai I Hareven, MD 972544461022 hareven.psy@gmail.com

Locations
Israel
HaEmek Medical Center Recruiting
Afula, Israel
Contact: Amichai I Hareven, MD    972544461022    hareven.psy@gmail.com   
Principal Investigator: Amichai I Hareven, MD         
Sponsors and Collaborators
HaEmek Medical Center, Israel
  More Information

No publications provided

Responsible Party: Amichai Hareven, Dr Amichai Hareven, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT01681407     History of Changes
Other Study ID Numbers: EMC-07411-CTIL
Study First Received: September 5, 2012
Last Updated: January 31, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by HaEmek Medical Center, Israel:
Depression
Selective Serotonin Reuptake Inhibitors
MicroRNAs
Proteome

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014