The Purpose of the Study is to Gain an In-depth Picture o... | NCT01377896

Studies
The Purpose of the Study is to Gain an In-depth Picture of the Patient Management and Prescription Behaviours

NCT01377896

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Jun 28, 2011Estimated

Enrollment

221Actual

Phase

Not provided

Conditions

Schizophrenia
Bipolar Disorders
Major Depressive Disorders

Interventions

Not provided

Countries

Not provided

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 2011

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

Jul 2010

Primary Completion Date

Oct 2010Actual

Completion Date

Oct 2010Actual

First Submitted Date

Jun 14, 2011

First Submission Date that Met QC Criteria

Jun 20, 2011

First Posted Date

Jun 22, 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

Jun 27, 2011

Last Update Posted Date

Jun 28, 2011Estimated

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

'Real life' retrospective patient cases (10) to provide an objective and robust analytical report of patient management and prescriptions behaviours for Schizophrenia, Bipolar disorders and Major depressive disorders.

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

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

221Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients diagnosed with one of the following conditions: Schizophrenia, Bipolar disorders and Major depressive disorders.

Exclusion Criteria:

Patients who have not been diagnosed with the conditions as outlined in the Inclusion criteria.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with cardiovascular events

Sampling Method

Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia
D001714	Bipolar Disorder
D003865	Depressive Disorder, Major

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders
D000068105	Bipolar and Related Disorders
D019964	Mood Disorders

Browse Leaves

Not provided

Browse Branches

Not provided