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

Phase 1

Completed

• Conditions: Healthy

• Registration Number: NCT01638689
• Lead Sponsor: Karolinska Institutet

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Primary Completion: 2011-02
• Status Verified: 2012-07
• Study Completion: 2012-07
• Study First Submitted: 2012-07-03
• Study First Submitted QC: 2012-07-11
• Last Update Submitted: 2012-07-11
• Study First Posted: 2012-07-12
• Last Update Posted: 2012-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

Inclusion Criteria

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

Exclusion Criteria

1. Past or present psychiatric disease
2. Past or present brain disorder or injury, including loss of consciousness for more than five minutes
3. Past or present drug or alcohol abuse
4. Past or present use of antidepressant or antipsychotic medications
5. Regular use of medications (including herbals), that could interfere with the pharmacodynamics or pharmacokinetics of escitalopram
6. Significant abnormality on ECG
7. Structural abnormality in the brain confirmed by MR examination
8. Claustrophobia
9. Any metal devises or implants in the body
10. Intolerance to escitalopram or any of the components of the formula
11. Predisposition to motion sickness
12. Inability to understand and comply with the study requirements
13. Any medical condition that, in the opinion of the investigator, make the subject unsuitable for the study or put the subject at additional risk

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

PET center, Department of Clinical neuroscience, Karolinska Institutet; 🇸🇪 Stockholm, Sweden