- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01518049
Clinical Validation of the Rating Scale for Psychotic Depression (RAS-PD)
October 12, 2015 updated by: Søren Dinesen Østergaard
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Aalborg, Denmark, 9000
- Unit for Psychiatric Research, Aalborg Psychiatric Hospital, Aarhus University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
inpatients or outpatients at Danish Psychiatric Hospitals fulfilling criteria for unipolar depression with psychotic symptoms.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Søren D Østergaard, MD, Aahus University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2012
Primary Completion (Actual)
September 1, 2013
Study Completion (Actual)
September 1, 2014
Study Registration Dates
First Submitted
January 21, 2012
First Submitted That Met QC Criteria
January 21, 2012
First Posted (Estimate)
January 25, 2012
Study Record Updates
Last Update Posted (Estimate)
October 14, 2015
Last Update Submitted That Met QC Criteria
October 12, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- N-20110029
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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