Functional Neuroimaging in Depression

Back to results

Primary Purpose

Status

Completed

Phase

Phase 2

Locations

Belgium

Study Type

Interventional

Intervention

Oral administration of escitalopram during 8 weeks

About this trial

This is an interventional treatment trial for Major Depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Hospital Ghent
AZ Groeninge campus Sint Maarten

Outcomes

Primary Outcome Measures

Brain metabolism

Secondary Outcome Measures

Cognitive functions

Efficacy scales (mood, anxiety, anger and hopelessness)

Full Information

NCT ID

NCT00343070

First Posted

June 19, 2006

Last Updated

August 30, 2010

Sponsor

University Hospital, Ghent

Collaborators

Fund for Scientific Research, Flanders, Belgium, H. Lundbeck A/S

1. Study Identification

Unique Protocol Identification Number

NCT00343070

Brief Title

Functional Neuroimaging in Depression

Official Title

Functional Neuroimaging in Depression: Longitudinal Study of PET Metabolism in Correlation With Changes in Attentional Bias, Autobiographical Memory, Future Fluency and Facial Recognition in Depressed Patients Treated With Escitalopram.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2010

Overall Recruitment Status

Completed

Study Start Date

March 2007 (undefined)

Primary Completion Date

October 2009 (Actual)

Study Completion Date

October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital, Ghent

Collaborators

Fund for Scientific Research, Flanders, Belgium, H. Lundbeck A/S

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depression

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Oral administration of escitalopram during 8 weeks

Primary Outcome Measure Information:

Title

Brain metabolism

Secondary Outcome Measure Information:

Title

Cognitive functions

Title

Efficacy scales (mood, anxiety, anger and hopelessness)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

No

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kurt Audenaert, MD, PhD

Organizational Affiliation

University Hospital, Ghent

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital Ghent

City

Ghent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

AZ Groeninge campus Sint Maarten

City

Kortrijk

ZIP/Postal Code

8500

Country

Belgium

12. IPD Sharing Statement

Links:

URL

http://www.uzgent.be

Description

Website University Hospital Ghent

Major Depression

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial