NCT00343070

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2007

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 22, 2006

Completed
8 months until next milestone

Study Start

First participant enrolled

March 1, 2007

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

August 31, 2010

Status Verified

August 1, 2010

Enrollment Period

2.6 years

First QC Date

June 19, 2006

Last Update Submit

August 30, 2010

Conditions

Major Depression

Outcome Measures

Primary Outcomes (1)

  • Brain metabolism

Secondary Outcomes (2)

  • Cognitive functions

  • Efficacy scales (mood, anxiety, anger and hopelessness)

Interventions

Oral administration of escitalopram during 8 weeksDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • IQ below 80
  • Conditions not compatible with SPC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital Ghent

Ghent, 9000, Belgium

Location

AZ Groeninge campus Sint Maarten

Kortrijk, 8500, Belgium

Location

Related Links

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Kurt Audenaert, MD, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 19, 2006

First Posted

June 22, 2006

Study Start

March 1, 2007

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

August 31, 2010

Record last verified: 2010-08

Locations

BE(2)