Clinical Validation of the Rating Scale for Psychotic Dep... | NCT01518049

Studies
Clinical Validation of the Rating Scale for Psychotic Depression (RAS-PD)

NCT01518049

Sponsor

Søren Dinesen Østergaard

Status

Completed

Last Update Posted

Oct 14, 2015Estimated

Enrollment

50Actual

Phase

Not provided

Conditions

Affective Disorders, Psychotic

Interventions

Not provided

Countries

Denmark

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

Oct 2015

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

Feb 2012

Primary Completion Date

Sep 2013Actual

Completion Date

Sep 2014Actual

First Submitted Date

Jan 21, 2012

First Submission Date that Met QC Criteria

Jan 21, 2012

First Posted Date

Jan 25, 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

Oct 12, 2015

Last Update Posted Date

Oct 14, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Søren Dinesen Østergaard, Principal Investigator, Aarhus University HospitalSponsor-Investigator

Lead Sponsor

Søren Dinesen ØstergaardOTHER

Collaborators

Not provided

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 aim of this study is to develop a scale to measure the severity of depression with psychotic symptoms (psychotic depression). Furthermore, we hope to detect potential biomarkers (substances in the blood) which can aid in the detection of psychotic depression.

Main hypothesis: A clinically valid rating scale measuring the severity of psychotic depression can be developed.

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

Retention

Enrollment

50Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Fulfilling ICD-10 criteria DF32.3 or DF33.3
At least 18 years old
Legally competent
Informed consent (oral & written)

Exclusion Criteria:

Insufficient Danish Language skills
Moderate to severe dementia
Abuse of psychoactive substances

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

inpatients or outpatients at Danish Psychiatric Hospitals fulfilling criteria for unipolar depression with psychotic symptoms.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Søren D Østergaard, MD	Aahus University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Unit for Psychiatric Research, Aalborg Psychiatric Hospital, Aarhus University Hospital		Aalborg		9000	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25462426	Result	Ostergaard SD, Pedersen CH, Uggerby P, Munk-Jorgensen P, Rothschild AJ, Larsen JI, Gotzsche C, Sondergaard MG, Bille AG, Bolwig TG, Larsen JK, Bech P. Clinical and psychometric validation of the psychotic depression assessment scale. J Affect Disord. 2015 Mar 1;173:261-8. doi: 10.1016/j.jad.2014.11.012. Epub 2014 Nov 18.

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders