NCT00295347

Brief Summary

The proposed research aims to compare the onset of action and the efficacy of fludrocortisone, a mineralocorticoid receptor agonist vs. spironolactone, a mineralocorticoid antagonist, vs. placebo as augmentation to a selective serotonin reuptake inhibitor (SSRI) in 65 inpatients with severe depression. The study will also explore the utility of the hypothalamic-pituitary-adrenal (HPA) axis in predicting treatment response. The study will be a 5-week randomized and double-blind trial of fludrocortisone vs. spironolactone vs. placebo during three years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2005

Typical duration for not_applicable

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

Study Start

First participant enrolled

December 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 23, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

2.5 years

First QC Date

February 22, 2006

Last Update Submit

May 24, 2017

Conditions

Major Depression

Interventions

SpironolactoneDRUG
fludrocortisoneDRUG
escitalopramDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Depressed male and female inpatients according to DSM-IV
  • Age between 18 and 70 years
  • Minimum of 17-items Hamilton Depression Score of 18
  • Informed consent signed

You may not qualify if:

  • Relevant medical or neurological disorders
  • Pregnancy or unsure contraception
  • Relevant psychiatric comorbidity
  • Active alcohol or other substance abuse/dependance
  • Contraindications to SSRI, fludrocortisone, or spironolactone
  • Steroid medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

SpironolactoneFludrocortisoneEscitalopram

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsHydrocortisonePregnenedionesPropylaminesAminesNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Christian Otte, MD

    Universitätsklinikum Hamburg-Eppendorf

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2006

First Posted

February 23, 2006

Study Start

December 1, 2005

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

May 30, 2017

Record last verified: 2017-05

Locations

DE(1)