A PET Study to Determine Alterations in Serotonin Levels in Human Brain After a Single Dose of Escitalopram
1 other identifier
interventional
10
1 country
1
Brief 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 concentration.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Sep 2010
Longer than P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 3, 2012
CompletedFirst Posted
Study publicly available on registry
July 12, 2012
CompletedJuly 12, 2012
July 1, 2012
5 months
July 3, 2012
July 11, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in binding potential of 11C-AZ10419369 between baseline and post-dose condition
One day (PET measurement before and after escitalopram administration on the same day)
Interventions
20 mg p.o.
Eligibility Criteria
You may qualify if:
- Signed informed consent
- Male gender
- Age 20 to 30 years
- Healthy according to physical examination, ECG, MRI and blood chemistry
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PET center, Department of Clinical neuroscience, Karolinska Institutet
Stockholm, S-17176, Sweden
Related Publications (1)
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.
PMID: 23351590DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Magdalena Nord, MD
Karolinska Institutet
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
July 3, 2012
First Posted
July 12, 2012
Study Start
September 1, 2010
Primary Completion
February 1, 2011
Study Completion
July 1, 2012
Last Updated
July 12, 2012
Record last verified: 2012-07