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Oral Fluency and the Response to Antidepressant Therapy in the Elderly With a Unipolar Depressive Episode (PREDICTage)

Primary Purpose

Unipolar Depression

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Neuropsychological evaluations
Psychiatric interview
Cardiovascular risk assessment
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Unipolar Depression

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Centre Hospitalier Universitaire de BesançonRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm

Arm Description

Psychiatric interview, Neuropsychological evaluations, cardiovascular risk assessment

Outcomes

Primary Outcome Measures

Ability of the verbal fluency test score to predict the response to antidepressive treatment
verbal fluency is assessed during the neuropsychological assessment

Secondary Outcome Measures

Full Information

First Posted
July 21, 2017
Last Updated
July 21, 2017
Sponsor
Centre Hospitalier Universitaire de Besancon
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1. Study Identification

Unique Protocol Identification Number
NCT03227133
Brief Title
Oral Fluency and the Response to Antidepressant Therapy in the Elderly With a Unipolar Depressive Episode
Acronym
PREDICTage
Official Title
An Exploratory Study of the Use of Oral Fluency as a Predictive Tool for the Antidepressant Response of Elderly With Unipolar Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 23, 2016 (Actual)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
June 23, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single arm
Arm Type
Experimental
Arm Description
Psychiatric interview, Neuropsychological evaluations, cardiovascular risk assessment
Intervention Type
Other
Intervention Name(s)
Neuropsychological evaluations
Intervention Description
Neuropsychological evaluations including oral fluency, performed specifically for the study
Intervention Type
Other
Intervention Name(s)
Psychiatric interview
Intervention Type
Other
Intervention Name(s)
Cardiovascular risk assessment
Primary Outcome Measure Information:
Title
Ability of the verbal fluency test score to predict the response to antidepressive treatment
Description
verbal fluency is assessed during the neuropsychological assessment
Time Frame
week 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Depressive episode according to DSM-5 criteria Unipolar depression MADRS ≥ 20 Antidepressive treatment (Serotonin Reuptake Inhibitors/Serotonin Norepinephrine Reuptake Inhibitors) Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Monnin, PhD
Email
jmonnin@chu-besancon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline Masse-Sibille, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Besançon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Besançon
City
Besançon
ZIP/Postal Code
25000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Monnin, PhD
Email
jmonnin@chu-besancon.fr
First Name & Middle Initial & Last Name & Degree
Caroline Masse-Sibille, MD
First Name & Middle Initial & Last Name & Degree
Emmanuel Haffen, MD, PhD
First Name & Middle Initial & Last Name & Degree
Nazim Nekrouf, MD
First Name & Middle Initial & Last Name & Degree
Pierre Vandel, MS, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Oral Fluency and the Response to Antidepressant Therapy in the Elderly With a Unipolar Depressive Episode

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