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

An Exploratory Study of the Use of Oral Fluency as a Predictive Tool for the Antidepressant Response of Elderly With Unipolar Depressive Disorder

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.

Study Overview

• Status: Unknown
• Conditions: Unipolar Depression
• Intervention / Treatment: Other: Neuropsychological evaluations; Other: Psychiatric interview; Other: Cardiovascular risk assessment

• Study Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Besançon, France, 25000
    • Recruiting
    • CENTRE HOSPITALIER UNIVERSITAIRE de BESANCON
    • Contact: Julie MONNIN, PhD; Email: jmonnin@chu-besancon.fr
    • Principal Investigator: Caroline Masse-Sibille, MD
    • Sub-Investigator: Emmanuel Haffen, MD, PhD
    • Sub-Investigator: Nazim Nekrouf, MD
    • Sub-Investigator: Pierre Vandel, MS, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single arm; Psychiatric interview, Neuropsychological evaluations, cardiovascular risk assessment	Other: Neuropsychological evaluations; Neuropsychological evaluations including oral fluency, performed specifically for the study; Other: Psychiatric interview; Other: Cardiovascular risk assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ability of the verbal fluency test score to predict the response to antidepressive treatment	verbal fluency is assessed during the neuropsychological assessment	week 10

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon
• Investigators: Principal Investigator: Caroline Masse-Sibille, MD, CENTRE HOSPITALIER UNIVERSITAIRE de BESANCON

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2016
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): June 23, 2019

Study Registration Dates

• First Submitted: July 21, 2017
• First Submitted That Met QC Criteria: July 21, 2017
• First Posted (Actual): July 24, 2017

Study Record Updates

• Last Update Posted (Actual): July 24, 2017
• Last Update Submitted That Met QC Criteria: July 21, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder
• Other Study ID Numbers: P/2016/297

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No