Acute, Affective, Organic Disorders.

This study has been completed.

Sponsor:

Collaborators:

St. Olavs Hospital

Dr. Dedichens Institute for Psychiatric Research, Oslo, Norway.

GlaxoSmithKline

Information provided by:

Norwegian University of Science and Technology

ClinicalTrials.gov Identifier:

NCT00201474

First received: September 16, 2005

Last updated: June 7, 2010

Last verified: June 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

September 16, 2005

Last Updated Date

June 7, 2010

Start Date ^ICMJE

October 1998

Primary Completion Date

October 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00201474 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Acute, Affective, Organic Disorders.

Official Title ^ICMJE

Signs of Organic Brain Dysfunction in Psychiatric Patients With Fluctuating Psychiatric Symptoms Including Brief Depressions Compared to Patients With a Major Depressive Episode.

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.

Detailed Description

A limited number of patients admitted to psychiatric acute wards or Psychiatric Intensive Care Units are admitted with a fluctuating array of psychiatric symptoms including brief depressive episodes. These patients do not fit into the present diagnostic systems due to short duration of affective symptoms and the fluctuating arrays of other symptoms. Case histories indicate that these patients have psychiatric conditions due to epilepsy or organic brain dysfunctions.

In the study acutely admitted patients filling criteria for two recent DSM-4 axis 1 diagnoses (one is a brief depressive period) during the last two weeks are compared to age- and sex-matched patients acutely admitted with a major depressive disorder. The patients are rated with a number of rating scales at admittance, day 5, after two weeks and three months. EEG and QEEG are taken three times the first week. MRI, drug screening and blood screening of medication-concentrations are taken.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples Without DNA

Description:

Ordinary laboratory tests, medication, substances.

Sampling Method

Probability 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.

Condition ^ICMJE

Acute Psychiatry
Depressive Disorders

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Vaaler AE, Morken G, Linaker OM, Sand T, Kvistad KA, Bråthen 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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2010

Primary Completion Date

October 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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)

Exclusion Criteria:

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Norway

Administrative Information

NCT Number ^ICMJE

NCT00201474

Other Study ID Numbers ^ICMJE

AEV-98

Has Data Monitoring Committee

Responsible Party

Prof Olav Linaker, St Olavs University Hospital, Division Psychiatry, Norwegian University of Science and Technology

Study Sponsor ^ICMJE

Norwegian University of Science and Technology

Collaborators ^ICMJE

St. Olavs Hospital
Dr. Dedichens Institute for Psychiatric Research, Oslo, Norway.
GlaxoSmithKline

Investigators ^ICMJE

Study Chair:

Olav M Linaker, Professor

Norwegian University of Science and Technology

Information Provided By

Norwegian University of Science and Technology

Verification Date

June 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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