DepressionPhase 4NCT00145132
Beta-CIT-SPECT and Neurophysiology in Depression
A Phase 4 study testing β-CIT-SPECT, Neurophysiology in people with Depression, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
Aim of this project is to investigate the effects of escitalopram on monoamine transporter (SERT, DAT) availabilities as assessed by b-CIT and SPECT, and on neurophysiological parameters such as the loudness dependence of auditory evoked potentials (LDAEP) in patients with depression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- β-CIT-SPECT, Neurophysiology
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2005to Dec 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Psychiatric in or outpatients with acute depressive episode
- Indication for pharmacological treatment
Who cannot join
- Acute suicidality
- Neurological or severe somatic disorders
- Occupational exposition to radiation >15 mSv per year
- Women during pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
Germany1 site
Depts. of Psychiatry and Nuclear Medicine, Ludwig-Maximilians-University of Munich
Munich, D-80336
About this study
Official title: Serotonin and Dopamine Transporter (SERT, DAT) Availabilities as Assessed by b-CIT and SPECT, and Neurophysiological Measures of Central Serotonergic Activity in Patients With Depression Under Treatment With Escitalopram
Aim of this project is to investigate the effects of escitalopram on monoamine transporter (SERT, DAT) availabilities as assessed by b-CIT and SPECT, and on neurophysiological parameters such as the loudness dependence of auditory evoked potentials (LDAEP) in patients with depression.
- Conditions
- Depression
- Being tested
- β-CIT-SPECT, Neurophysiology
- Keywords
- depression, β-CIT-SPECT, SERT, DAT, neurophysiology, LDAEP, escitalopram, SSRI
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
β-CIT-SPECT, NeurophysiologyProcedure or surgery
β-CIT-SPECT scans and EEG recordings, two assessments each
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in β-CIT/neurophysiological measurements 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 posted5 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionDec 2009
- Study completionDec 2009
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- H. Lundbeck A/S
- Investigators
- Oliver Pogarell, MD, Principal investigator, Dept. of Psychiatry, University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00145132
- Sponsor's protocol ID
- ESCIT-SPECT-Pogarell
- Other IDs
- EK287/98
- Status last verified
- May 2010
- First submitted
- 1 Sep 2005
- Last updated
- 2 Jun 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serotonin and Dopamine Transporter (SERT, DAT) Availabilities as Assessed by b-CIT and SPECT, and Neurophysiological Measures of Central Serotonergic Activity in Patients With Depression Under Treatment With Escitalopram
- ClinicalTrials.gov ID
- NCT00145132
- Acronym / sponsor ID
- ESCIT-SPECT-Pogarell
- Conditions
- Depression
- Keywords
- depression, β-CIT-SPECT, SERT, DAT, neurophysiology, LDAEP, escitalopram, SSRI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- H. Lundbeck A/S
- Study start
- Jun 2005
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 5 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.
Aim of this project is to investigate the effects of escitalopram on monoamine transporter (SERT, DAT) availabilities as assessed by b-CIT and SPECT, and on neurophysiological parameters such as the loudness dependence of auditory evoked potentials (LDAEP) in patients with depression.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Psychiatric in or outpatients with acute depressive episode
- Indication for pharmacological treatment
Key exclusion criteria (4 listed)
- Acute suicidality
- Neurological or severe somatic disorders
- Occupational exposition to radiation >15 mSv per year
- 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 |
|---|---|---|
| β-CIT-SPECT, Neurophysiologyβ-CIT-SPECT scans and EEG recordings, two assessments each | Procedure or surgery | – |
Primary outcome
changes in β-CIT/neurophysiological measurements from baseline to week 4
Time frame: two assessments, at baseline and week 4
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 2 Jun 2010.
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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.
Oliver Pogarell, MD principal investigator
Dept. of Psychiatry, University of Munich
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 β-CIT-SPECT, Neurophysiology 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 4 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 2 Jun 2010. 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 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?
changes in β-CIT/neurophysiological measurements 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 2 Jun 2010.