Depressive DisordersNCT00201474
Acute, Affective, Organic Disorders.
An observational study of Depressive Disorders, run by Norwegian University of Science and Technology at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Disorders
- How many people
- 32 participants
- Where
- 1 siteNorway
- Study dates
- Oct 1998to Jun 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study and control groups both from a psychiatric acute ward. The patients are acutely admitted suffering from different types of depressive symptoms.
Who may be able to join
- 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)
Who cannot join
- Patients not speaking Norwegian or English.
- Patients not willing to participate.
- Patients with dementia or mental retardation to an extensive degree.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Østmarka Psychiatric Department, St. Olavs Hospital
Trondheim, 7441
About this study
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.
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.
Read the 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.
- Conditions
- Depressive Disorders
- Keywords
- brief depressive episodes, affective disorders, EEG and QEEG, epilepsy, organic brain disorders, acute psychiatry
- Medical subject headings
- Depressive Disorder, Mood Disorders, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| brief depressive periods | brief depressive periods together with other fluctuating psychiatric symptoms | |
| major depressive disorder | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
epilepsy or an other organic brain disorder
EEG and QEEG are taken three times in the first week
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startOct 1998
- Primary completionOct 2004
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Depressive DisordersStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, Dr. Dedichens Institute for Psychiatric Research, Oslo, Norway., GlaxoSmithKline
- Investigators
- Olav M Linaker, Professor, Study chair, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00201474
- Sponsor's protocol ID
- AEV-98
- Status last verified
- Aug 2016
- First submitted
- 16 Sep 2005
- Last updated
- 4 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 20673344Vaaler 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.
PubMed 19793395
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00201474
- Acronym / sponsor ID
- AEV-98
- Conditions
- Depressive Disorders
- Keywords
- brief depressive episodes, affective disorders, EEG and QEEG, epilepsy, organic brain disorders, acute psychiatry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, Dr. Dedichens Institute for Psychiatric Research, Oslo, Norway., GlaxoSmithKline
- Study start
- Oct 1998
- Primary completion
- Oct 2004 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| brief depressive periods | – | –brief depressive periods together with other fluctuating psychiatric symptoms |
| major depressive disorder | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study and control groups both from a psychiatric acute ward. The patients are acutely admitted suffering from different types of depressive symptoms.
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (3 listed)
- Patients not speaking Norwegian or English.
- Patients not willing to participate.
- Patients with dementia or mental retardation to an extensive degree.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
epilepsy or an other organic brain disorder
Time frame: 1 week
EEG and QEEG are taken three times in the first week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2016.
- Results publication: PubMed 20673344Vaaler 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.
- Derived from this study: PubMed 19793395Vaaler 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.
Related trials for Depressive Disorders
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Not yet recruitingObservational study
Ecological Momentary Assessment of State-Dependent Decision-Making and Metacognition Across a Psychopathology Continuum
Depression, Anxiety
Not yet recruiting
Adapting the ESTEEM Intervention to Improve Mental Health and PrEP Uptake Among Men at Risk of HIV
PrEP Use
Recruiting
Cancer Pain Management Using a Web-based Intervention
Cancer of Breast, Depressive Symptoms
Active, not recruiting
Improving Student Mental Health Through a Universal Trauma-Informed Intervention
Anxiety Symptoms, Post-traumatic Stress Symptoms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olav M Linaker, Professor study chair
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depressive Disorders, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
epilepsy or an other organic brain disorder (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00201474, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2016.