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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01638689
• Other study ID #: 2010-019363-11
• Secondary ID: 2010-019363-11
• Status: Completed
• Phase: Phase 1
• First received: July 3, 2012
• Last updated: July 11, 2012
• Start date: September 2010
• Est. completion date: July 2012

Study information

• Verified date: July 2012
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencySweden: Regional Ethical Review Board StockholmSweden: Local Radiation Safety Committee, Stockholm
• Study type: Interventional

Clinical 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 concentration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2012
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 30 Years

Eligibility

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

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Escitalopram
20 mg p.o.

Locations

Country	Name	City	State
Sweden	PET center, Department of Clinical neuroscience, Karolinska Institutet	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No