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

Unipolar Depression Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03227133
• Other study ID #: P/2016/297
• Status: Recruiting
• Phase: N/A
• First received: July 21, 2017
• Last updated: July 21, 2017
• Start date: December 23, 2016
• Est. completion date: June 23, 2019

Study information

• Verified date: July 2017
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Julie Monnin, PhD
• Email: jmonnin[@]chu-besancon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: June 23, 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depressive Disorder
• Unipolar Depression

Intervention

Other:
• Neuropsychological evaluations
Neuropsychological evaluations including oral fluency, performed specifically for the study
• Psychiatric interview

• Cardiovascular risk assessment

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Besançon	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability of the verbal fluency test score to predict the response to antidepressive treatment	verbal fluency is assessed during the neuropsychological assessment	week 10