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

Sponsor

Centre Hospitalier Universitaire de Besancon (Other)

Overall Status

Unknown status

CT.gov ID

NCT03227133

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Unipolar Depression	Other: Neuropsychological evaluations Other: Psychiatric interview Other: Cardiovascular risk assessment	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

42 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

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

Actual Study Start Date :

Dec 23, 2016

Anticipated Primary Completion Date :

Jun 1, 2019

Anticipated Study Completion Date :

Jun 23, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Ability of the verbal fluency test score to predict the response to antidepressive treatment [week 10]
verbal fluency is assessed during the neuropsychological assessment

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Universitaire de Besançon	Besançon		France	25000

Sponsors and Collaborators

Centre Hospitalier Universitaire de Besancon

Investigators

Principal Investigator: Caroline Masse-Sibille, MD, Centre Hospitalier Universitaire de Besançon

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Besancon

ClinicalTrials.gov Identifier:

NCT03227133

Other Study ID Numbers:

P/2016/297

First Posted:

Jul 24, 2017

Last Update Posted:

Jul 24, 2017

Last Verified:

Jul 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Depressive Disorder

Study Results

No Results Posted as of Jul 24, 2017