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

NCT ID: NCT03227133

Last Updated: 2017-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-23

Study Completion Date

2019-06-23

Brief Summary

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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.

Detailed Description

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Conditions

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Unipolar Depression

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Single arm

Psychiatric interview, Neuropsychological evaluations, cardiovascular risk assessment

Group Type EXPERIMENTAL

Neuropsychological evaluations

Intervention Type OTHER

Neuropsychological evaluations including oral fluency, performed specifically for the study

Psychiatric interview

Intervention Type OTHER

Cardiovascular risk assessment

Intervention Type OTHER

Interventions

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Neuropsychological evaluations

Neuropsychological evaluations including oral fluency, performed specifically for the study

Intervention Type OTHER

Psychiatric interview

Intervention Type OTHER

Cardiovascular risk assessment

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Caroline Masse-Sibille, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Besançon

Locations

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Centre Hospitalier Universitaire de Besançon

Besançon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Julie Monnin, PhD

Role: CONTACT

Facility Contacts

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Julie Monnin, PhD

Role: primary

Other Identifiers

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P/2016/297

Identifier Type: -

Identifier Source: org_study_id

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