EpilepsyNCT00855725
Affective Processing in Depression and Epilepsy
An observational study of Epilepsy and Depression, run by Northwell Health at 1 site in United States.
Trial summary
The goal of this study is to determine whether there are unique markers on neuroimaging that are associated with depression in epilepsy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Epilepsy, Depression, Healthy
- What is being tested?
- fMRI, Hamilton Depression Rating Scale and Beck's Depressive Inventory
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Jun 2009
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: There are four study groups. 1. Healthy Controls 2. Subjects with epilepsy only 3. Subjects with primary depression only 4. Subjects with epilepsy and depressive symptoms.
Who may be able to join
- Healthy adults of 18 years of age or older.
- Subject is at least 18 years of age
- Subject has confirmed temporal lobe epilepsy (TLE)
- Subject is at least 18 years of age
- Subject scores between 12 and 18 on Hamilton Depression Rating Scale
- Subject has confirmed temporal lobe epilepsy (TLE)
- Subject scores between 12 and 18 on Hamilton Depression Rating Scale
Who cannot join
- Subject has no history of affective disorders
- Subject scores higher than 5 on Hamilton Depression Rating Scale
- Subject with prior primary diagnosis of any psychotic disorder, bipolar disorder, anxiety disorder, or any other serious medical or neurological disorder
- Subject is pregnant
- Subject is unable to undergo a MRI
- Epilepsy Only Group
Show all 24Show fewer
- Subject has a history of depression
- Subject scores higher then 5 on Hamilton Depression Rating Scale
- Subject with prior primary diagnosis of any psychotic disorder, bipolar disorder, anxiety disorder, or any other serious medical or neurological disorder
- Subject is pregnant
- Subject is unable to undergo a MRI
- Depression Only Group
- Subject scores higher than 18 on Hamilton Depression Rating Scale
- Subject is currently being medicated for depression
- Subject has history of major depression or dysthymia
- Subject with prior primary diagnosis of any psychotic disorder, bipolar disorder, anxiety disorder, or any other serious medical or neurological disorder
- Subject is pregnant
- Subject is unable to undergo a MRI
- Depression and Epilepsy Group
- Subject has history of major depression or dysthymia
- Subject is currently on medication for depression
- Subject with prior primary diagnosis of any psychotic disorder, bipolar disorder, anxiety disorder, or any other serious medical or neurological disorder
- Subject is pregnant
- Subject is unable to undergo a MRI
Trial locations and contacts
1 site in 1 country.
United States1 site
North Shore LIJ Health System
Manhasset, New York, 11030
About this study
Official title: Affective Processing in Depression and Epilepsy; An fMRI Study
The goal of this study is to determine whether there are unique markers on neuroimaging that are associated with depression in epilepsy.
Read the detailed description
Symptoms of depression is commonly seen in patients with epilepsy. There are similarities and differences between depressive symptoms in epilepsy when compared with primary depression. Through the use of fMRI (Functional MRI), we hope to determine whether there are unique markers on neuroimaging that are associated with depression in epilepsy.
- Conditions
- Epilepsy, Depression, Healthy
- Being tested
- fMRI, Hamilton Depression Rating Scale, Beck's Depressive Inventory, Interictal Dysphoric Disorder Inventory (IDDI)
- Keywords
- Epilepsy, Depression, Neurology, fMRI, Healthy Controls
- Medical subject headings
- Epilepsy, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRIOther
Subjects will undergo MRI scanning to gather data about cognetive functions.
Hamilton Depression Rating ScaleOther
Investigator will evalute the subject during a one on one interview for depression using the Hamilton Depression Rating Scale.
Beck's Depressive InventoryOther
Subjects will complete self assessment to evaluate their level of depression.
Interictal Dysphoric Disorder Inventory (IDDI)Other
Subject will complete self assessment to determine if there have been any changes in mood, emotions and or feelings from time to time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2009 (estimated)
- Study startJun 2008
- Primary completionJun 2009
- Study completionJun 2009
Why it stopped: PI wanted to discontinue study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Investigators
- Alan Ettinger, M.D., Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00855725
- Sponsor's protocol ID
- GCRC 0246
- Other IDs
- 08-128
- Status last verified
- Jul 2009
- First submitted
- 3 Mar 2009
- Last updated
- 9 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Affective Processing in Depression and Epilepsy; An fMRI Study
- ClinicalTrials.gov ID
- NCT00855725
- Acronym / sponsor ID
- GCRC 0246
- Conditions
- Epilepsy, Depression, Healthy
- Keywords
- Epilepsy, Depression, Neurology, fMRI, Healthy Controls
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI wanted to discontinue study.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 4 Mar 2009 (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 goal of this study is to determine whether there are unique markers on neuroimaging that are associated with depression in epilepsy.
Detailed description
Symptoms of depression is commonly seen in patients with epilepsy. There are similarities and differences between depressive symptoms in epilepsy when compared with primary depression. Through the use of fMRI (Functional MRI), we hope to determine whether there are unique markers on neuroimaging that are associated with depression in epilepsy.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- There are four study groups. 1. Healthy Controls 2. Subjects with epilepsy only 3. Subjects with primary depression only 4. Subjects with epilepsy and depressive symptoms.
Key inclusion criteria (7 listed)
- Healthy adults of 18 years of age or older.
- Subject is at least 18 years of age
- Subject has confirmed temporal lobe epilepsy (TLE)
- Subject is at least 18 years of age
- Subject scores between 12 and 18 on Hamilton Depression Rating Scale
Key exclusion criteria (24 listed)
- Subject has no history of affective disorders
- Subject scores higher than 5 on Hamilton Depression Rating Scale
- Subject with prior primary diagnosis of any psychotic disorder, bipolar disorder, anxiety disorder, or any other serious medical or neurological disorder
- Subject is pregnant
- Subject is unable to undergo a MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fMRISubjects will undergo MRI scanning to gather data about cognetive functions. | Other | – |
| Hamilton Depression Rating ScaleInvestigator will evalute the subject during a one on one interview for depression using the Hamilton Depression Rating Scale. | Other | – |
| Beck's Depressive InventorySubjects will complete self assessment to evaluate their level of depression. | Other | – |
| Interictal Dysphoric Disorder Inventory (IDDI)Subject will complete self assessment to determine if there have been any changes in mood, emotions and or feelings from time to time. | Other | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: PI wanted to discontinue study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2009.
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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.
Alan Ettinger, M.D. principal investigator
Northwell Health
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 Epilepsy and Depression, run by Northwell Health at 1 site in United States.
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 7 inclusion and 24 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: stopped early, as of the sponsor's last update on 9 Jul 2009. 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 United States. 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 was stopped early (reason given: PI wanted to discontinue study.). Results are not available in the source record.
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.
Where can I read the original study information?
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 9 Jul 2009; AzTrials last refreshed its copy on 27 Oct 2026.