Major DepressionPhase 2NCT00343070
Functional Neuroimaging in Depression
A Phase 2 study testing Oral administration of escitalopram during 8 weeks in people with Major Depression, run by University Hospital, Ghent at 2 sites in Belgium.
Trial summary
Oral administration of escitalopram during 8 weeks; PET scan with 18F-FDG at inclusion and after 8 weeks Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depression
- What is being tested?
- Oral administration of escitalopram during 8 weeks
- Type of treatment
- Pill or oral medicine
- How many people
- 40 participants
- Where
- 2 sitesBelgium
- Study dates
- Mar 2007to Oct 2009
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major Depression, Depressive episode, following DSM-IV criteria
- MADRS-score > 25
- Age: 18-65 yrs
- Medication-free or anti-depressant wash-out 7 days (for fluoxetine: 6 weeks)
- Lorazepam 1mg or zolpidem 10mg are allowed
Who cannot join
- Suicidality
- Bipolar disorder, following DSM-IV criteria
- Psychotic symptoms
- Substance abuse
- Personality disorder, following DSM-IV criteria
- Cognitive dysfunction due to trauma capitis or dementia
Show all 11Show fewer
- Diabetes mellitus
- Women without contraceptive protection, with pregnancy or breast feeding
- Pharmacological treatment or ingestion of substance that can influence cerebral perfusion less than a month before inclusion
- IQ below 80
- Conditions not compatible with SPC
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
University Hospital Ghent
Ghent, 9000
AZ Groeninge campus Sint Maarten
Kortrijk, 8500
About this study
Official title: Functional Neuroimaging in Depression: Longitudinal Study of PET Metabolism in Correlation With Changes in Attentional Bias, Autobiographical Memory, Future Fluency and Facial Recognition in Depressed Patients Treated With Escitalopram.
Oral administration of escitalopram during 8 weeks; PET scan with 18F-FDG at inclusion and after 8 weeks
- Conditions
- Major Depression
- Being tested
- Oral administration of escitalopram during 8 weeks
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral administration of escitalopram during 8 weeksDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain metabolism
Secondary outcomes (2)
Cognitive functions
Efficacy scales (mood, anxiety, anger and hopelessness)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2006 (estimated)
- Study startMar 2007
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major DepressionStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium, H. Lundbeck A/S
- Investigators
- Kurt Audenaert, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00343070
- Sponsor's protocol ID
- 2006/176
- Status last verified
- Aug 2010
- First submitted
- 19 Jun 2006
- Last updated
- 31 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Neuroimaging in Depression: Longitudinal Study of PET Metabolism in Correlation With Changes in Attentional Bias, Autobiographical Memory, Future Fluency and Facial Recognition in Depressed Patients Treated With Escitalopram.
- ClinicalTrials.gov ID
- NCT00343070
- Acronym / sponsor ID
- 2006/176
- Conditions
- Major Depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium, H. Lundbeck A/S
- Study start
- Mar 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 22 Jun 2006 (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.
Oral administration of escitalopram during 8 weeks; PET scan with 18F-FDG at inclusion and after 8 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Major Depression, Depressive episode, following DSM-IV criteria
- MADRS-score > 25
- Age: 18-65 yrs
- Medication-free or anti-depressant wash-out 7 days (for fluoxetine: 6 weeks)
- Lorazepam 1mg or zolpidem 10mg are allowed
Key exclusion criteria (11 listed)
- Suicidality
- Bipolar disorder, following DSM-IV criteria
- Psychotic symptoms
- Substance abuse
- Personality disorder, following DSM-IV criteria
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 |
|---|---|---|
| Oral administration of escitalopram during 8 weeks | Drug | – |
Primary outcome
Brain metabolism
2 secondary outcomes
Cognitive functions
Efficacy scales (mood, anxiety, anger and hopelessness)
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 31 Aug 2010.
- Website University Hospital GhentLink provided by the sponsor.
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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.
Kurt Audenaert, MD, PhD principal investigator
University Hospital, Ghent
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral administration of escitalopram during 8 weeks in people with Major Depression, run by University Hospital, Ghent at 2 sites in Belgium.
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 5 inclusion and 11 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 31 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Brain metabolism. It is what the study was designed to measure, not a finding.
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 31 Aug 2010.