Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Søren Dinesen Østergaard, Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT01518049
First received: January 21, 2012
Last updated: July 18, 2013
Last verified: July 2013
  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:


Further study details as provided by Aarhus University Hospital:

Biospecimen Retention:   Samples With DNA

blood samples


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

Ages Eligible for Study:   18 Years and older
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

No publications provided

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: July 18, 2013
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:
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 23, 2014