A PET Study to Determine Alterations in Serotonin Levels... | NCT01638689

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

NCT01638689

Sponsor

Karolinska Institutet

Status

Completed

Last Update Posted

Jul 12, 2012Estimated

Enrollment

10Actual

Phase

Phase 1

Conditions

Healthy

Interventions

Escitalopram

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2010-019363-11	EudraCT Number

Status Module

Record Verification Date

Jul 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Feb 2011Actual

Completion Date

Jul 2012Actual

First Submitted Date

Jul 3, 2012

First Submission Date that Met QC Criteria

Jul 11, 2012

First Posted Date

Jul 12, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 11, 2012

Last Update Posted Date

Jul 12, 2012Estimated

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Name	Type	Description	Arm Group Labels	Other Names
Escitalopram	Drug	20 mg p.o.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed informed consent
Male gender
Age 20 to 30 years
Healthy according to physical examination, ECG, MRI and blood chemistry

Exclusion Criteria:

Past or present psychiatric disease
Past or present brain disorder or injury, including loss of consciousness for more than five minutes
Past or present drug or alcohol abuse
Past or present use of antidepressant or antipsychotic medications
Regular use of medications (including herbals), that could interfere with the pharmacodynamics or pharmacokinetics of escitalopram
Significant abnormality on ECG
Structural abnormality in the brain confirmed by MR examination
Claustrophobia
Any metal devises or implants in the body
Intolerance to escitalopram or any of the components of the formula
Predisposition to motion sickness
Inability to understand and comply with the study requirements
Any medical condition that, in the opinion of the investigator, make the subject unsuitable for the study or put the subject at additional risk

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Magdalena Nord, MD	Karolinska Institutet	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
PET center, Department of Clinical neuroscience, Karolinska Institutet		Stockholm		S-17176	Sweden

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23351590	Derived	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.

ID	Term
D011437	Propylamines
D000588	Amines
D009930	Organic Chemicals
D009570	Nitriles
D001572