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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01518049
First Posted: January 25, 2012
Last Update Posted: October 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Søren Dinesen Østergaard, Aarhus University Hospital
  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:

U.S. FDA Resources

Further study details as provided by Søren Dinesen Østergaard, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:

Responsible Party: Søren Dinesen Østergaard, Principal Investigator, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT01518049     History of Changes
Other Study ID Numbers: N-20110029
First Submitted: January 21, 2012
First Posted: January 25, 2012
Last Update Posted: October 14, 2015
Last Verified: October 2015

Keywords provided by Søren Dinesen Østergaard, 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