Functional Neuroimaging in Depression

NCT ID: NCT00343070

Last Updated: 2010-08-31

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

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2009-10-31

Brief Summary

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Oral administration of escitalopram during 8 weeks; PET scan with 18F-FDG at inclusion and after 8 weeks

Detailed Description

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Conditions

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Major Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Oral administration of escitalopram during 8 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Major Depression, Depressive episode, following DSM-IV criteria
* MADRS-score \> 25
* Age: 18-65 yrs
* Medication-free or anti-depressant wash-out 7 days (for fluoxetine: 6 weeks)
* Lorazepam 1mg or zolpidem 10mg are allowed

Exclusion Criteria

* Suicidality
* Bipolar disorder, following DSM-IV criteria
* Psychotic symptoms
* Substance abuse
* Personality disorder, following DSM-IV criteria
* Cognitive dysfunction due to trauma capitis or dementia
* Diabetes mellitus
* Women without contraceptive protection, with pregnancy or breast feeding
* Pharmacological treatment or ingestion of substance that can influence cerebral perfusion less than a month before inclusion
* IQ below 80
* Conditions not compatible with SPC
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fund for Scientific Research, Flanders, Belgium

OTHER

Sponsor Role collaborator

H. Lundbeck A/S

INDUSTRY

Sponsor Role collaborator

University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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University Hospital Ghent

Principal Investigators

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Kurt Audenaert, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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University Hospital Ghent

Ghent, , Belgium

Site Status

AZ Groeninge campus Sint Maarten

Kortrijk, , Belgium

Site Status

Countries

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Belgium

Related Links

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http://www.uzgent.be

Website University Hospital Ghent

Other Identifiers

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2006/176

Identifier Type: -

Identifier Source: org_study_id