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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Søren Dinesen Østergaard, Aarhus University Hospital

ClinicalTrials.gov Identifier:

NCT01518049

First received: January 21, 2012

Last updated: October 12, 2015

Last verified: October 2015

History of Changes

Purpose

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.

Condition
Affective Disorders, Psychotic


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective

Resource links provided by NLM:

Genetics Home Reference related topics: schizophrenia

MedlinePlus related topics: Mental Disorders Mood Disorders Psychotic Disorders

U.S. FDA Resources

Further study details as provided by Aarhus University Hospital:

Biospecimen Retention: Samples With DNA

blood samples


Enrollment:	50
Study Start Date:	February 2012
Study Completion Date:	September 2014
Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01518049

Locations


Denmark
Unit for Psychiatric Research, Aalborg Psychiatric Hospital, Aarhus University Hospital
Aalborg, Denmark, 9000

Sponsors and Collaborators

Søren Dinesen Østergaard

Investigators


Principal Investigator:	Søren D Østergaard, MD	Aahus University Hospital

More Information

Publications:

Østergaard SD, Pedersen CH, Uggerby P, Munk-Jørgensen P, Rothschild AJ, Larsen JI, Gøtzsche C, Søndergaard 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.


Responsible Party:	Søren Dinesen Østergaard, Principal Investigator, Aarhus University Hospital
ClinicalTrials.gov Identifier:	NCT01518049 History of Changes
Other Study ID Numbers:	N-20110029
Study First Received:	January 21, 2012
Last Updated:	October 12, 2015
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Aarhus University Hospital:


Affective Disorders, Psychotic Psychometrics Biological Markers

Additional relevant MeSH terms:


Mental Disorders Psychotic Disorders Mood Disorders Affective Disorders, Psychotic Schizophrenia Spectrum and Other Psychotic Disorders

ClinicalTrials.gov processed this record on September 23, 2016

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