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

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ClinicalTrials.gov Identifier: NCT01638689
Recruitment Status : Completed
First Posted : July 12, 2012
Last Update Posted : July 12, 2012
Sponsor:
Information provided by (Responsible Party):
Magdalena Nord, Karolinska Institutet

Tracking Information
First Submitted Date  ICMJE July 3, 2012
First Posted Date  ICMJE July 12, 2012
Last Update Posted Date July 12, 2012
Study Start Date  ICMJE September 2010
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2012)
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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A PET Study to Determine Alterations in Serotonin Levels in Human Brain After a Single Dose of Escitalopram
Official Title  ICMJE A PET Study to Determine Alterations in Serotonin Levels in Human Brain After a Single Dose of Escitalopram
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE Drug: Escitalopram
20 mg p.o.
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 11, 2012)
10
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01638689
Other Study ID Numbers  ICMJE 2010-019363-11
2010-019363-11 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Magdalena Nord, Karolinska Institutet
Study Sponsor  ICMJE Karolinska Institutet
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Magdalena Nord, MD Karolinska Institutet
PRS Account Karolinska Institutet
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP