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

NCT ID: NCT01638689

Last Updated: 2012-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-07-31

Brief Summary

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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

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Conditions

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Healthy

Keywords

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Mechanism of Action of escitalopram

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Interventions

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Escitalopram

20 mg p.o.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Magdalena Nord

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Magdalena Nord, MD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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PET center, Department of Clinical neuroscience, Karolinska Institutet

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 23351590 (View on PubMed)

Other Identifiers

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2010-019363-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2010-019363-11

Identifier Type: -

Identifier Source: org_study_id