Badalona Major Depressive Disorder Database Study | NCT01446692

Studies
Badalona Major Depressive Disorder Database Study

NCT01446692

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Jan 12, 2012Estimated

Enrollment

2,260Actual

Phase

Not provided

Conditions

Major Depressive Disorder

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

Status Module

Record Verification Date

Jan 2012

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

Nov 2011

Primary Completion Date

Not provided

Completion Date

Jan 2012Actual

First Submitted Date

Sep 28, 2011

First Submission Date that Met QC Criteria

Oct 4, 2011

First Posted Date

Oct 5, 2011Estimated

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

Jan 11, 2012

Last Update Posted Date

Jan 12, 2012Estimated

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

A retrospective study using a data base of anonymized medical records. The purpose of the study is to examine the different therapeutic strategies for the management of patients with major depressive disorder (MDD) and suboptimal response to antidepressant drugs in primary care

Detailed Description

Therapeutic strategies for the management of patients with major depressive disorder (MDD) and suboptimal response to antidepressant drugs in primary care: the Badalona database 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

2,260Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Description of the antidepressant strategies switches	Number and type of treatment changes including combination, switch, or augmentation strategies.	18 months

Secondary Outcomes

Measure	Description	Time Frame
Health care resource utilization		18 months
Health care costs		18 months
Hamilton Depression Rating Scale

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

An International Classification of Primary Care (ICPC-2) or DSM-IV-TR diagnosis for major depressive disorder (MDD)
At least 8 weeks of antidepressant treatment during the identification period of 01 January 2008 - 31 December 2009
18 months of enrollment with medical and pharmacy records after index episode date

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

Primary care clinic

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D003865	Depressive Disorder, Major

Ancestor Terms

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
Patients with suboptimal response
Patients with symptomatic remission