A PET Study to Determine Alterations in Serotonin Levels in Human Brain After a Single Dose of Escitalopram

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.

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Key information

Conditions

Healthy

Age range

20 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

PET center, Department of Clinical neuroscience, Karolinska Institutet

Stockholm, S-17176, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Signed informed consent
Male gender
Age 20 to 30 years
Healthy according to physical examination, ECG, MRI and blood chemistry

Exclusion criteria

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

Treatment and study plan

Escitalopram

Drug

20 mg p.o.

Primary outcomes

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)

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2012
First posted: Jul 12, 2012
Registry last updated: Jul 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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