NCT00201474

Brief Summary

The purpose of the study is to investigate whether patients with brief depressive periods together with other fluctuating psychiatric symptoms, have this condition due to epilepsy or an other organic brain disorder.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 1998

Longer than P75 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

Study Start

First participant enrolled

October 1, 1998

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

August 4, 2016

Status Verified

August 1, 2016

Enrollment Period

6 years

First QC Date

September 16, 2005

Last Update Submit

August 3, 2016

Conditions

Keywords

brief depressive episodesaffective disordersEEG and QEEGepilepsyorganic brain disordersacute psychiatry

Outcome Measures

Primary Outcomes (1)

  • epilepsy or an other organic brain disorder

    EEG and QEEG are taken three times in the first week

    1 week

Study Arms (2)

brief depressive periods

brief depressive periods together with other fluctuating psychiatric symptoms

major depressive disorder

Eligibility Criteria

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

Study and control groups both from a psychiatric acute ward. The patients are acutely admitted suffering from different types of depressive symptoms.

You may qualify if:

  • Acutely admitted psychiatric patients who have at different times the last 2 weeks filled criteria for at least two new DSM-4 Axis 1 psychiatric diagnoses. One of them has to be a depressive episode (MADRS\>20)

You may not qualify if:

  • Patients not speaking Norwegian or English.
  • Patients not willing to participate.
  • Patients with dementia or mental retardation to an extensive degree.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Østmarka Psychiatric Department, St. Olavs Hospital

Trondheim, 7441, Norway

Location

Related Publications (2)

  • Vaaler AE, Morken G, Iversen VC, Kondziella D, Linaker OM. Acute Unstable Depressive Syndrome (AUDS) is associated more frequently with epilepsy than major depression. BMC Neurol. 2010 Jul 30;10:67. doi: 10.1186/1471-2377-10-67.

  • Vaaler AE, Morken G, Linaker OM, Sand T, Kvistad KA, Brathen G. Symptoms of epilepsy and organic brain dysfunctions in patients with acute, brief depression combined with other fluctuating psychiatric symptoms: a controlled study from an acute psychiatric department. BMC Psychiatry. 2009 Sep 30;9:63. doi: 10.1186/1471-244X-9-63.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Ordinary laboratory tests, medication, substances.

MeSH Terms

Conditions

Depressive DisorderMood DisordersEpilepsy

Condition Hierarchy (Ancestors)

Mental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Olav M Linaker, Professor

    Norwegian University of Science and Technology

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 20, 2005

Study Start

October 1, 1998

Primary Completion

October 1, 2004

Study Completion

June 1, 2010

Last Updated

August 4, 2016

Record last verified: 2016-08

Locations