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

July 11, 2012 updated by: Magdalena Nord, Karolinska Institutet
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, S-17176
        • PET center, Department of Clinical neuroscience, Karolinska Institutet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
One day (PET measurement before and after escitalopram administration on the same day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Investigators

  • Principal Investigator: Magdalena Nord, MD, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

July 3, 2012

First Submitted That Met QC Criteria

July 11, 2012

First Posted (Estimate)

July 12, 2012

Study Record Updates

Last Update Posted (Estimate)

July 12, 2012

Last Update Submitted That Met QC Criteria

July 11, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-019363-11 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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