NCT03227133

Brief Summary

The study focuses on the identification of clinical, physiological and morphological markers that could predict the response to antidepressant in elderly suffering from unipolar depressive disorder.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 23, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 24, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2019

Completed
Last Updated

July 24, 2017

Status Verified

July 1, 2017

Enrollment Period

2.4 years

First QC Date

July 21, 2017

Last Update Submit

July 21, 2017

Conditions

Unipolar Depression

Outcome Measures

Primary Outcomes (1)

  • Ability of the verbal fluency test score to predict the response to antidepressive treatment

    verbal fluency is assessed during the neuropsychological assessment

    week 10

Study Arms (1)

Single arm

EXPERIMENTAL

Psychiatric interview, Neuropsychological evaluations, cardiovascular risk assessment

Other: Neuropsychological evaluationsOther: Psychiatric interviewOther: Cardiovascular risk assessment

Interventions

Neuropsychological evaluationsOTHER

Neuropsychological evaluations including oral fluency, performed specifically for the study

Single arm
Psychiatric interviewOTHER
Single arm
Cardiovascular risk assessmentOTHER
Single arm

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Depressive episode according to DSM-5 criteria
  • Unipolar depression
  • MADRS ≥ 20
  • Antidepressive treatment (Serotonin Reuptake Inhibitors/Serotonin Norepinephrine Reuptake Inhibitors)

You may not qualify if:

  • Other comorbid mental disorders (bipolar disorder, schizophrenia, recent addiction \< 3 months except for tobacco)
  • Depression with psychotic features
  • Serious unstabilized somatic illness
  • Protected persons
  • Dementia suspected at the time of enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Besançon

Besançon, 25000, France

RECRUITING

MeSH Terms

Conditions

Depressive Disorder

Condition Hierarchy (Ancestors)

Mood DisordersMental Disorders

Study Officials

  • Caroline Masse-Sibille, MD

    Centre Hospitalier Universitaire de Besançon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie Monnin, PhD

CONTACT

jmonnin@chu-besancon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2017

First Posted

July 24, 2017

Study Start

December 23, 2016

Primary Completion

June 1, 2019

Study Completion

June 23, 2019

Last Updated

July 24, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)