Functional Neuroimaging in Depression | NCT00343070

Studies
Functional Neuroimaging in Depression

NCT00343070

Sponsor

University Hospital, Ghent

Status

Completed

Last Update Posted

Aug 31, 2010Estimated

Enrollment

40Estimated

Phase

Phase 2

Conditions

Major Depression

Interventions

Oral administration of escitalopram during 8 weeks

Countries

Belgium

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

Status Module

Record Verification Date

Aug 2010

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

Mar 2007

Primary Completion Date

Oct 2009Actual

Completion Date

Oct 2009Actual

First Submitted Date

Jun 19, 2006

First Submission Date that Met QC Criteria

Jun 20, 2006

First Posted Date

Jun 22, 2006Estimated

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

Aug 30, 2010

Last Update Posted Date

Aug 31, 2010Estimated

Name	Class
Fund for Scientific Research, Flanders, Belgium	OTHER
H. Lundbeck A/S	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Name	Type	Description	Arm Group Labels	Other Names
Oral administration of escitalopram during 8 weeks	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Brain metabolism

Secondary Outcomes

Measure	Description	Time Frame
Cognitive functions
Efficacy scales (mood, anxiety, anger and hopelessness)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kurt Audenaert, MD, PhD	University Hospital, Ghent	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Ghent		Ghent		9000	Belgium
AZ Groeninge campus Sint Maarten

Label	URL
Website University Hospital Ghent	View source

Condition Browse Module

MeSH Terms

ID	Term
D003865	Depressive Disorder, Major

Ancestor Terms

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided