DepressionNCT00263133
Modulation of Visually Evoked Potentials by an Antidepressant
A study testing Sertraline in people with Depression, run by University Hospital Freiburg at 1 site in Germany.
Trial summary
12 normal healthy controls will be treated with 50 mg sertraline once daily for three weeks. Early amplitudes of visually evoked potentials will be examined at day 0, 10 and 21 and statistically compared. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Sertraline
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2005to Jan 2006
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy individuals 18-65 years
Who cannot join
- history of affective oder other psyhiatric disorder
- severe medical condition
- pregnancy or ineffective contraception
- active illicit drug use
Trial locations and contacts
1 site in 1 country.
Germany1 site
Dept. of Psychiatry, University of Freiburg
Freiburg im Breisgau, 79104
About this study
12 normal healthy controls will be treated with 50 mg sertraline once daily for three weeks. Early amplitudes of visually evoked potentials will be examined at day 0, 10 and 21 and statistically compared. This study aims to examine a putative modulation of synaptic transmission and plasticity by an antidepressant and is part of a series of studies in healthy individuals and depressed patients.
- Conditions
- Depression
- Being tested
- Sertraline
- Keywords
- Depression, SSRI, Sertraline, synaptic plasticity, visually evoked potentials
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SertralineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Amplitudes and latencies of early visually evoked potentials.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2005 (estimated)
- Study startDec 2005
- Study completionJan 2006
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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants
Sponsor and investigators
- Lead sponsor
- University Hospital Freiburg
- Sponsor type
- University, hospital or other
- Investigators
- Claus Normann, MD, Principal investigator, Dept. of Psychiatry, University of Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00263133
- Sponsor's protocol ID
- VEP-1
- Other IDs
- EudraCT 2005-005417-37
- Status last verified
- May 2007
- First submitted
- 6 Dec 2005
- Last updated
- 4 Jun 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Visually Evoked Potentials by an Antidepressant
- ClinicalTrials.gov ID
- NCT00263133
- Acronym / sponsor ID
- VEP-1
- Conditions
- Depression
- Keywords
- Depression, SSRI, Sertraline, synaptic plasticity, visually evoked potentials
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants
- Lead sponsor
- University Hospital FreiburgUniversity, hospital or other
- Study start
- Dec 2005
- Study completion
- Jan 2006
- First posted
- 7 Dec 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.
12 normal healthy controls will be treated with 50 mg sertraline once daily for three weeks. Early amplitudes of visually evoked potentials will be examined at day 0, 10 and 21 and statistically compared. This study aims to examine a putative modulation of synaptic transmission and plasticity by an antidepressant and is part of a series of studies in healthy individuals and depressed patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy individuals 18-65 years
Key exclusion criteria (4 listed)
- history of affective oder other psyhiatric disorder
- severe medical condition
- pregnancy or ineffective contraception
- active illicit drug use
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 |
|---|---|---|
| Sertraline | Drug | – |
Primary outcome
Amplitudes and latencies of early visually evoked potentials.
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 Jun 2007.
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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.
Claus Normann, MD principal investigator
Dept. of Psychiatry, University of Freiburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sertraline in people with Depression, run by University Hospital Freiburg 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 1 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 4 Jun 2007. 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.
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?
Amplitudes and latencies of early visually evoked potentials.. 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 4 Jun 2007.