- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00201474
Acute, Affective, Organic Disorders.
Signs of Organic Brain Dysfunction in Psychiatric Patients With Fluctuating Psychiatric Symptoms Including Brief Depressions Compared to Patients With a Major Depressive Episode.
Study Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Trondheim, Norway, 7441
- Østmarka Psychiatric Department, St. Olavs Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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major depressive disorder
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brief depressive periods
brief depressive periods together with other fluctuating psychiatric symptoms
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
epilepsy or an other organic brain disorder
Time Frame: 1 week
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EEG and QEEG are taken three times in the first week
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1 week
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Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Olav M Linaker, Professor, Norwegian University of Science and Technology
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AEV-98
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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