NCT00386841

Brief Summary

The purpose of this study is to determine whether outcome following antidepressant treatment can be used as a tool to evaluate endo-phenotypes for depression.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P75+ for phase_4 healthy

Timeline
Completed

Started Apr 2007

Typical duration for phase_4 healthy

Geographic Reach
1 country

1 active site

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

October 11, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 12, 2006

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

June 30, 2009

Status Verified

June 1, 2009

Enrollment Period

2.2 years

First QC Date

October 11, 2006

Last Update Submit

June 29, 2009

Conditions

Healthy

Keywords

Major depressionFirst degree relativesEscitalopramCortisolCognitionPersonalityEndo-phenotype

Outcome Measures

Primary Outcomes (1)

  • Changes in the response on the combined dexamethasone corticotropin-releasing hormone test before and after 4 weeks treatment with escitalopram or placebo.

    4-6 weeks

Secondary Outcomes (8)

  • Changes in scores before and after 4 weeks treatment with escitalopram or placebo on: Cognition

    4-6 weeks

  • Social function

    4-6 weeks

  • Neuroticism

    4-6 weeks

  • Subjective; sleep, pain, aggression, depression, anxiety, quality of life, perceived stress and side-effects

    4-6 weeks

  • Receptor status by PET-scans

    4-6 weeks

  • +3 more secondary outcomes

Study Arms (2)

A Escitalopram 10 mg

ACTIVE COMPARATOR

Escitalopram 10 mg

Drug: Escitalopram

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

EscitalopramDRUG

Escitalopram 10 mg p.o. per day

Also known as: cipralex
A Escitalopram 10 mg
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Offsprings or siblings of patients with major depression
  • Born in Denmark with European parents and grandparents
  • For women; not pregnant or breastfeeding
  • Written informed consent

You may not qualify if:

  • Somatically illness or other handicaps which make participation in the study impossible
  • Daily intake of drugs interfering with corticosteroids or escitalopram
  • Hypersensitivity to escitalopram, dexamethasone or human corticotropin-releasing hormone
  • Former medical or psychological treatment for diseases in the affective or schizophrenic spectrum
  • Ongoing addiction of alcohol or psychoactive drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychiatric Department of Rigshospitalet

Blegdamsvej 9, Copenhagen OE, 2100, Denmark

Location

Related Publications (3)

  • Knorr U, Vinberg M, Mortensen EL, Winkel P, Gluud C, Wetterslev J, Gether U, Kessing LV. Effect of chronic escitalopram versus placebo on personality traits in healthy first-degree relatives of patients with depression: a randomized trial. PLoS One. 2012;7(2):e31980. doi: 10.1371/journal.pone.0031980. Epub 2012 Feb 29.

    PMID: 22393376DERIVED

  • Knorr U, Vinberg M, Hansen A, Klose M, Feldt-Rasmussen U, Hilsted L, Hasselstrom J, Gether U, Winkel P, Gluud C, Wetterslev J, Kessing LV. Escitalopram and neuroendocrine response in healthy first-degree relatives to depressed patients--a randomized placebo-controlled trial. PLoS One. 2011;6(6):e21224. doi: 10.1371/journal.pone.0021224. Epub 2011 Jun 27.

    PMID: 21738622DERIVED

  • Knorr U, Vinberg M, Klose M, Feldt-Rasmussen U, Hilsted L, Gade A, Haastrup E, Paulson O, Wetterslev J, Gluud C, Gether U, Kessing L. Rationale and design of the participant, investigator, observer, and data-analyst-blinded randomized AGENDA trial on associations between gene-polymorphisms, endophenotypes for depression and antidepressive intervention: the effect of escitalopram versus placebo on the combined dexamethasone-corticotrophine releasing hormone test and other potential endophenotypes in healthy first-degree relatives of persons with depression. Trials. 2009 Aug 11;10:66. doi: 10.1186/1745-6215-10-66.

    PMID: 19671139DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

EscitalopramDexetimide

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPiperidonesPiperidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Lars V Kessing, DMSc

    Psychiatric Department of Rigshospitalet, Blegdamsvej 9, DK-2100 Copenhagen OE

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 11, 2006

First Posted

October 12, 2006

Study Start

April 1, 2007

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

June 30, 2009

Record last verified: 2009-06

Locations

DK(1)