DepressionPhase 4NCT00386893
Somatosensory Processing in Depression
A Phase 4 study testing simultaneous EEG/fMRI and fMRI in people with Depression, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
Aim of this study is to investigate neuronal differences (EEG/evoked potentials; functional MRI) between patients with major depression and healthy controls concerning brain activity after acute pain as well as changes of pain related brain activity during treatment with escitalopram. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Depression
- What is being tested?
- simultaneous EEG/fMRI and fMRI
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2006to Dec 2011
- Phase
- Phase 4
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Psychiatric in or outpatients with acute depressive episode
- Indication for pharmacological treatment
Who cannot join
- Acute suicidal tendency
- Neurological or severe somatic disorders
- Women during pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Psychiatry and Clin. Radiology, Ludwig-Maximilian-University
Munich, Bavaria, D - 80336
About this study
Official title: Influence of Escitalopram on Somatosensory Processing in Patients With Major Depression
Aim of this study is to investigate neuronal differences (EEG/evoked potentials; functional MRI) between patients with major depression and healthy controls concerning brain activity after acute pain as well as changes of pain related brain activity during treatment with escitalopram.
- Conditions
- Depression
- Being tested
- simultaneous EEG/fMRI, fMRI
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simultaneous EEG/fMRIProcedure or surgery
fMRI/EEG recordings
fMRIDevice
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual | Other | simultaneous EEG/fMRI Receives: Procedure: simultaneous EEG/fMRI; Device: fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in evoked potentials/functional MRI from baseline to week 4
Measured: two assessments, at baseline and week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- H. Lundbeck A/S
- Responsible party
- Principal investigator, Oliver Pogarell, Ludwig-Maximilians - University of Munich
- Investigators
- Ulrich Hegerl, MD, Principal investigator, Department of Psychiatry, Ludwig-Maximilians-UniversityOliver Pogarell, MD, Principal investigator, Department of Psychiatry, Ludwig-Maximilians-University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00386893
- Sponsor's protocol ID
- ESC_03082005
- Other IDs
- 2005-003752-35, 2005
- Status last verified
- Apr 2015
- First submitted
- 10 Oct 2006
- Last updated
- 14 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Escitalopram on Somatosensory Processing in Patients With Major Depression
- ClinicalTrials.gov ID
- NCT00386893
- Acronym / sponsor ID
- ESC_03082005
- Conditions
- Depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- H. Lundbeck A/S
- Study start
- Oct 2006
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 12 Oct 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.
Aim of this study is to investigate neuronal differences (EEG/evoked potentials; functional MRI) between patients with major depression and healthy controls concerning brain activity after acute pain as well as changes of pain related brain activity during treatment with escitalopram.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual | Other | Procedure: simultaneous EEG/fMRI, Device: fMRIsimultaneous EEG/fMRI |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Psychiatric in or outpatients with acute depressive episode
- Indication for pharmacological treatment
Key exclusion criteria (3 listed)
- Acute suicidal tendency
- Neurological or severe somatic disorders
- Women during pregnancy or lactation
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 |
|---|---|---|
| simultaneous EEG/fMRIfMRI/EEG recordings | Procedure or surgery | Treatment as usual |
| fMRI | Device | Treatment as usual |
Primary outcome
changes in evoked potentials/functional MRI from baseline to week 4
Time frame: two assessments, at baseline and week 4
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2015.
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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.
Ulrich Hegerl, MD principal investigator
Department of Psychiatry, Ludwig-Maximilians-University
Oliver Pogarell, MD principal investigator
Department of Psychiatry, Ludwig-Maximilians-University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing simultaneous EEG/fMRI and fMRI in people with Depression, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
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 2 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: withdrawn, as of the sponsor's last update on 14 Apr 2015. 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 Germany. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was withdrawn before enrolling participants, so there are no results.
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?
changes in evoked potentials/functional MRI from baseline to week 4 (time frame: two assessments, at baseline and week 4). 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 14 Apr 2015.