Affective Disorders, PsychoticNCT01518049
Clinical Validation of the Rating Scale for Psychotic Depression (RAS-PD)
An observational study of Affective Disorders, Psychotic, run by Søren Dinesen Østergaard at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Affective Disorders, Psychotic
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2012to Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: inpatients or outpatients at Danish Psychiatric Hospitals fulfilling criteria for unipolar depression with psychotic symptoms.
Who may be able to join
- Fulfilling ICD-10 criteria DF32.3 or DF33.3
- At least 18 years old
- Legally competent
- Informed consent (oral \& written)
Who cannot join
- Insufficient Danish Language skills
- Moderate to severe dementia
- Abuse of psychoactive substances
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Unit for Psychiatric Research, Aalborg Psychiatric Hospital, Aarhus University Hospital
Aalborg, 9000
About this study
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.
- Conditions
- Affective Disorders, Psychotic
- Keywords
- Affective Disorders, Psychotic, Psychometrics, Biological Markers
- Medical subject headings
- Affective Disorders, Psychotic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study startFeb 2012
- Primary completionSep 2013
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Affective Disorders, PsychoticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Søren Dinesen Østergaard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Søren Dinesen Østergaard, Aarhus University Hospital
- Investigators
- Søren D Østergaard, MD, Principal investigator, Aahus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01518049
- Sponsor's protocol ID
- N-20110029
- Status last verified
- Oct 2015
- First submitted
- 21 Jan 2012
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Ostergaard SD, Pedersen CH, Uggerby P, Munk-Jorgensen P, Rothschild AJ, Larsen JI, Gotzsche C, Sondergaard 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.
PubMed 25462426
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of the Rating Scale for Psychotic Depression (RAS-PD)
- ClinicalTrials.gov ID
- NCT01518049
- Acronym / sponsor ID
- N-20110029
- Conditions
- Affective Disorders, Psychotic
- Keywords
- Affective Disorders, Psychotic, Psychometrics, Biological Markers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Søren Dinesen ØstergaardUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 25 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- inpatients or outpatients at Danish Psychiatric Hospitals fulfilling criteria for unipolar depression with psychotic symptoms.
Key inclusion criteria (4 listed)
- Fulfilling ICD-10 criteria DF32.3 or DF33.3
- At least 18 years old
- Legally competent
- Informed consent (oral \& written)
Key exclusion criteria (3 listed)
- Insufficient Danish Language skills
- Moderate to severe dementia
- Abuse of psychoactive substances
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
- Results publication: PubMed 25462426Ostergaard SD, Pedersen CH, Uggerby P, Munk-Jorgensen P, Rothschild AJ, Larsen JI, Gotzsche C, Sondergaard 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Søren D Østergaard, MD principal investigator
Aahus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Affective Disorders, Psychotic, run by Søren Dinesen Østergaard at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01518049, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2015.