Peripheral Plasma Micro-RNA and Proteomics Mapping in Dep... | NCT01681407

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

NCT01681407

Sponsor

HaEmek Medical Center, Israel

Status

Terminated

Last Update Posted

Jun 19, 2015Estimated

Enrollment

17Actual

Phase

Not provided

Conditions

Depression

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Insufficient microRNA for the analysis

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

Jul 2013Actual

Completion Date

Feb 2014Actual

First Submitted Date

Sep 5, 2012

First Submission Date that Met QC Criteria

Sep 7, 2012

First Posted Date

Sep 10, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2015

Last Update Posted Date

Jun 19, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

17Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Depressive symptoms remission or response rates, under usual SSRI treatment.		10 weeks of follow up

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D003863	Depression

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided