Study Evaluating Anxiety and Depression in Patients With... | NCT00884468

Studies
Study Evaluating Anxiety and Depression in Patients With Psoriatic Arthritis

NCT00884468

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Status

Completed

Last Update Posted

May 27, 2009Estimated

Enrollment

384Actual

Phase

Not provided

Conditions

Psoriatic Arthritis

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

May 2009

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

May 2008

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Apr 16, 2009

First Submission Date that Met QC Criteria

Apr 17, 2009

First Posted Date

Apr 20, 2009Estimated

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

May 26, 2009

Last Update Posted Date

May 27, 2009Estimated

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

This is an epidemiological non-interventional study assessing the prevalence of anxiety and/or depression disorders in patients suffering from Psoriatic Arthritis (PsA) in Spain.

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

384Actual

Label	Type	Description	Intervention Names
1		Patients with PsA that fulfill the eligibility criteria of the study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of anxiety and/or depression disorders in patients suffering from PsA in Spain as measured by the Hospital Anxiety and Depression Scale (HAD)		12 months

Secondary Outcomes

Measure	Description	Time Frame
To assess the relation between the PsA severity and the presence of anxiety and/or depression disorders in patients suffering from PsA in Spain.		12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Patients both genders over 18 years old
Patients with PsA diagnosis

Exclusion criteria:

Patients with PsA that suffer from other rheumatologic diseases or non-concomitant rheumatologic diseases that the investigator considers not to be appropriate for the study.
Patients with any medical or physical condition (cognitive damage or difficulties for understanding) that create difficulties for reading and completing the questionnaires described in the protocol.
Patients that in the study period are taking part in another clinical trial.

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

Patients with PsA from outpatient's surgery or primary health care centres

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Medical Monitor	Wyeth is now a wholly owned subsidiary of Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Reus	Tarragona	43201	Spain

Condition Browse Module

MeSH Terms

ID	Term
D015535	Arthritis, Psoriatic
D001008	Anxiety Disorders

Ancestor Terms

ID	Term
D025242	Spondylarthropathies
D025241	Spondylarthritis
D013166	Spondylitis
D013122	Spinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided