NCT01518049

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 25, 2012

Completed
7 days until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

October 14, 2015

Status Verified

October 1, 2015

Enrollment Period

1.6 years

First QC Date

January 21, 2012

Last Update Submit

October 12, 2015

Conditions

Affective Disorders, Psychotic

Keywords

Affective Disorders, PsychoticPsychometricsBiological Markers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

inpatients or outpatients at Danish Psychiatric Hospitals fulfilling criteria for unipolar depression with psychotic symptoms.

You may qualify if:

  • Fulfilling ICD-10 criteria DF32.3 or DF33.3
  • At least 18 years old
  • Legally competent
  • Informed consent (oral \& written)

You may not qualify if:

  • Insufficient Danish Language skills
  • Moderate to severe dementia
  • Abuse of psychoactive substances

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unit for Psychiatric Research, Aalborg Psychiatric Hospital, Aarhus University Hospital

Aalborg, 9000, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 25462426RESULT

Biospecimen

Retention: SAMPLES WITH DNA

blood samples

MeSH Terms

Conditions

Affective Disorders, Psychotic

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Søren D Østergaard, MD

    Aahus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 21, 2012

First Posted

January 25, 2012

Study Start

February 1, 2012

Primary Completion

September 1, 2013

Study Completion

September 1, 2014

Last Updated

October 14, 2015

Record last verified: 2015-10

Locations

DK(1)