Acute, Affective, Organic Disorders.

Depressive Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00201474
• Other study ID #: AEV-98
• Status: Completed
• Phase: N/A
• First received: September 16, 2005
• Last updated: August 3, 2016
• Start date: October 1998
• Est. completion date: June 2010

Study information

• Verified date: August 2016
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data Services
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 2010
• Est. primary completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorders
• Disease

Locations

Country	Name	City	State
Norway	Østmarka Psychiatric Department, St. Olavs Hospital	Trondheim

Sponsors (4)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Dr. Dedichens Institute for Psychiatric Research, Oslo, Norway., GlaxoSmithKline, St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	epilepsy or an other organic brain disorder	EEG and QEEG are taken three times in the first week	1 week	No