Assessment of MDD Management in Andalusia | NCT01510886

Studies
Assessment of MDD Management in Andalusia

NCT01510886

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Aug 13, 2014Estimated

Enrollment

5,309Actual

Phase

Not provided

Conditions

MDD Management Strategies

Interventions

Not provided

Countries

Spain

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

ID	Type	Description	Link
PismaEP

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Sep 2013Actual

Completion Date

Sep 2013Actual

First Submitted Date

Jan 12, 2012

First Submission Date that Met QC Criteria

Jan 17, 2012

First Posted Date

Jan 18, 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

Aug 12, 2014

Last Update Posted Date

Aug 13, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

The main objectives of this study are to describe medical professionals responsible of the management of patients with MDD in a representative region of Andalusia (in terms of type of sites managing the disease, and referral to SC criteria); Describe MDD patient characteristics at inclusion in the PISMA-Ep Study; and to evaluate those factors associated to a higher incidence of referral from PC to SC.

Detailed Description

Assessment of MDD management strategies in Andalusia: A Sub-analysis of the PismaEP Study

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,309Actual

Label	Type	Description	Intervention Names
1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Visits to Primary Care		From Jan 2010 to Jan 2011
Number of Visits to Secondary Care		From Jan 2010 to Jan 2011
Number of Referrals		From Jan 2010 to Jan 2011

Secondary Outcomes

Measure	Description	Time Frame
Demographics		From Jan 2010 to Jan 2011
Type of site		From Jan 2010 to Jan 2011
Type of therapeutic strategy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

MDD Diagnosis Participants of the PismaEP study 18 yo. or older

Exclusion Criteria:

No specific exclusion criteria

Accepts Healthy Volunteers

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

MDD patients treated in Primary Care or Secondary Care in the Region of Granada and recruited for the PISMA-Ep Study

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jorge Cervilla, MD	Hospital San Cecilio	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Granada			Spain