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

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ClinicalTrials.gov Identifier: NCT01518049
Recruitment Status : Completed
First Posted : January 25, 2012
Last Update Posted : October 14, 2015
Sponsor:
Information provided by (Responsible Party):
Søren Dinesen Østergaard, Aarhus University Hospital

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease
Affective Disorders, Psychotic

Study Design
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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : February 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2014

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Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Biospecimen Retention:   Samples With DNA
blood samples

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Responsible Party: Søren Dinesen Østergaard, Principal Investigator, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT01518049     History of Changes
Other Study ID Numbers: N-20110029
First Posted: January 25, 2012    Key Record Dates
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