HealthyPhase 1NCT01638689
A PET Study to Determine Alterations in Serotonin Levels in Human Brain After a Single Dose of Escitalopram
A Phase 1 study testing Escitalopram in people with Healthy, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Healthy males were examined with positron emission tomography (PET) and the radioligand 11C-AZ10419369, before and after administration of a single dose escitalopram. A change in the binding potential of 11C-AZ10419369 between the baseline and the post-dose condition was hypothesized to reflect a change in serotonin… Read more about this study
- Who is it for?
- Ages 20 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Escitalopram
- How many people
- 10 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2010to Jul 2012
- Phase
- Phase 1
- 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 20 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed informed consent
- Male gender
- Age 20 to 30 years
- Healthy according to physical examination, ECG, MRI and blood chemistry
Who cannot join
- Past or present psychiatric disease
- Past or present brain disorder or injury, including loss of consciousness for more than five minutes
- Past or present drug or alcohol abuse
- Past or present use of antidepressant or antipsychotic medications
- Regular use of medications (including herbals), that could interfere with the pharmacodynamics or pharmacokinetics of escitalopram
- Significant abnormality on ECG
Show all 13Show fewer
- Structural abnormality in the brain confirmed by MR examination
- Claustrophobia
- Any metal devises or implants in the body
- Intolerance to escitalopram or any of the components of the formula
- Predisposition to motion sickness
- Inability to understand and comply with the study requirements
- Any medical condition that, in the opinion of the investigator, make the subject unsuitable for the study or put the subject at additional risk
Trial locations and contacts
1 site in 1 country.
Sweden1 site
PET center, Department of Clinical neuroscience, Karolinska Institutet
Stockholm, S-17176
About this study
Healthy males were examined with positron emission tomography (PET) and the radioligand 11C-AZ10419369, before and after administration of a single dose escitalopram. A change in the binding potential of 11C-AZ10419369 between the baseline and the post-dose condition was hypothesized to reflect a change in serotonin concentration.
- Conditions
- Healthy
- Being tested
- Escitalopram
- Keywords
- Mechanism of Action of escitalopram
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscitalopramDrug
20 mg p.o.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in binding potential of 11C-AZ10419369 between baseline and post-dose condition
Measured: One day (PET measurement before and after escitalopram administration on the same day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2012 (estimated)
- Study startSep 2010
- Primary completionFeb 2011
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magdalena Nord, Karolinska Institutet
- Investigators
- Magdalena Nord, MD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01638689
- Sponsor's protocol ID
- 2010-019363-11
- Other IDs
- 2010-019363-11
- Status last verified
- Jul 2012
- First submitted
- 3 Jul 2012
- Last updated
- 12 Jul 2012
- Results posted
- No
Publications
Nord M, Finnema SJ, Halldin C, Farde L. Effect of a single dose of escitalopram on serotonin concentration in the non-human and human primate brain. Int J Neuropsychopharmacol. 2013 Aug;16(7):1577-86. doi: 10.1017/S1461145712001617. Epub 2013 Jan 25.
PubMed 23351590
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PET Study to Determine Alterations in Serotonin Levels in Human Brain After a Single Dose of Escitalopram
- ClinicalTrials.gov ID
- NCT01638689
- Acronym / sponsor ID
- 2010-019363-11
- Conditions
- Healthy
- Keywords
- Mechanism of Action of escitalopram
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 12 Jul 2012 (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.
Healthy males were examined with positron emission tomography (PET) and the radioligand 11C-AZ10419369, before and after administration of a single dose escitalopram. A change in the binding potential of 11C-AZ10419369 between the baseline and the post-dose condition was hypothesized to reflect a change in serotonin concentration.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Signed informed consent
- Male gender
- Age 20 to 30 years
- Healthy according to physical examination, ECG, MRI and blood chemistry
Key exclusion criteria (13 listed)
- Past or present psychiatric disease
- Past or present brain disorder or injury, including loss of consciousness for more than five minutes
- Past or present drug or alcohol abuse
- Past or present use of antidepressant or antipsychotic medications
- Regular use of medications (including herbals), that could interfere with the pharmacodynamics or pharmacokinetics of escitalopram
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 |
|---|---|---|
| Escitalopram20 mg p.o. | Drug | – |
Primary outcome
Change in binding potential of 11C-AZ10419369 between baseline and post-dose condition
Time frame: One day (PET measurement before and after escitalopram administration on the same day)
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 12 Jul 2012.
- Derived from this study: PubMed 23351590Nord M, Finnema SJ, Halldin C, Farde L. Effect of a single dose of escitalopram on serotonin concentration in the non-human and human primate brain. Int J Neuropsychopharmacol. 2013 Aug;16(7):1577-86. doi: 10.1017/S1461145712001617. Epub 2013 Jan 25.
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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.
Magdalena Nord, MD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Escitalopram in people with Healthy, run by Karolinska Institutet at 1 site in Sweden.
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 4 inclusion and 13 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 12 Jul 2012. 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 Sweden. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Change in binding potential of 11C-AZ10419369 between baseline and post-dose condition (time frame: One day (PET measurement before and after escitalopram administration on the same day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01638689, which also lists 1 linked publication.
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 12 Jul 2012; AzTrials last refreshed its copy on 8 Nov 2026.