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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Escitalopram Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A PET Study to Determine Alterations in Serotonin Levels in Human Brain After a Single Dose of Escitalopram
Study Start Date : September 2010
Actual Primary Completion Date : February 2011
Actual Study Completion Date : July 2012

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Arms and Interventions
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Intervention Details:
  • Drug: Escitalopram
    20 mg p.o.

Outcome Measures
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Primary Outcome Measures :
  1. 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) ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01638689


Locations
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Sweden
PET center, Department of Clinical neuroscience, Karolinska Institutet
Stockholm, Sweden, S-17176
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Principal Investigator: Magdalena Nord, MD Karolinska Institutet
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Magdalena Nord, MD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01638689     History of Changes
Other Study ID Numbers: 2010-019363-11
2010-019363-11 ( EudraCT Number )
First Posted: July 12, 2012    Key Record Dates
Last Update Posted: July 12, 2012
Last Verified: July 2012
Keywords provided by Magdalena Nord, Karolinska Institutet:
Mechanism of Action of escitalopram
Additional relevant MeSH terms:
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Dexetimide
Citalopram
Serotonin
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
 Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Serotonin Receptor Agonists