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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01518049
Other study ID # N-20110029
Secondary ID
Status Completed
Phase N/A
First received January 21, 2012
Last updated October 12, 2015
Start date February 2012
Est. completion date September 2014

Study information

Verified date October 2015
Source Aarhus University Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: The Danish National Committee on Biomedical Research Ethics
Study type Observational

Clinical 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.

Main hypothesis: A clinically valid rating scale measuring the severity of psychotic depression can be developed.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date September 2014
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
Denmark Unit for Psychiatric Research, Aalborg Psychiatric Hospital, Aarhus University Hospital Aalborg

Sponsors (1)

Lead Sponsor Collaborator
Søren Dinesen Østergaard

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Østergaard SD, Pedersen CH, Uggerby P, Munk-Jørgensen P, Rothschild AJ, Larsen JI, Gøtzsche C, Søndergaard MG, Bille AG, Bolwig TG, Larsen JK, Bech P. Clinical and psychometric validation of the psychotic depression assessment scale. J Affect Disord. 2015 — View Citation

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