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

Not Applicable

• Conditions: Unipolar Depression
• Interventions: Other: Neuropsychological evaluations; Other: Psychiatric interview; Other: Cardiovascular risk assessment

• Registration Number: NCT03227133
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-23
• Status Verified: 2017-07
• Study First Submitted: 2017-07-21
• Study First Submitted QC: 2017-07-21
• Last Update Submitted: 2017-07-21
• Study First Posted: 2017-07-24
• Last Update Posted: 2017-07-24
• Primary Completion: 2019-06
• Study Completion: 2019-06-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	Cardiovascular risk assessment	Psychiatric interview, Neuropsychological evaluations, cardiovascular risk assessment
Single arm	Neuropsychological evaluations	Psychiatric interview, Neuropsychological evaluations, cardiovascular risk assessment
Single arm	Psychiatric interview	Psychiatric interview, Neuropsychological evaluations, cardiovascular risk assessment

Primary Outcome Measures

Name	Time	Method
Ability of the verbal fluency test score to predict the response to antidepressive treatment	week 10	verbal fluency is assessed during the neuropsychological assessment

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de Besançon; 🇫🇷 Besançon, France