Rhythm and Depression

Not Applicable

• Conditions: Depression
• Interventions: Other: rhythmic parameter recording; Behavioral: psychiatric assessment

• Registration Number: NCT02857036
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief Summary

The study aims to characterize the rhythmic parameters of unipolar depressed patients that are associated with the response to antidepressants after 6 weeks of treatment.

Detailed Description

Patients are included at the time of their hospitalization in the psychiatry unit. They perform rhythmic parameters recording within 48hours after the initiation of the antidepressant treatment. An evaluation of the evaluation of the severity of depression symptoms is performed at 2, 4 and 6 weeks after the initiation of the antidepressant treatment.

A correlation analysis will be performed with rhythmic parameters and the response to the antidepressant treatment.

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2016-08-02
• Study First Submitted QC: 2016-08-02
• Study First Posted: 2016-08-05
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-28
• Last Update Posted: 2017-03-01
• Primary Completion: 2018-09
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• current unipolar major depressive disorder according to the Diagnostic ans Statistics Manual (DSM)V
• MADRS score > 25

Exclusion Criteria

• other psychiatric disorder
• current treatment with thymoregulating agent
• clozapine treatment
• heart disease that could alter heart rate characteristics
• disease associated with fever
• shift work within 3 months before inclusion
• transmeridian travel in the preceding month
• guardianship

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
responder	rhythmic parameter recording	responder to antidepressant treatment
non responder	rhythmic parameter recording	non responder to antidepressant treatment
non responder	psychiatric assessment	non responder to antidepressant treatment
responder	psychiatric assessment	responder to antidepressant treatment

Primary Outcome Measures

Name	Time	Method
significant difference of temperature amplitude between responder and non-responder	6 weeks	the response to the antidepressant treatment is determined by the variation of the MADRS score between pretreatment and 6 weeks of treatment.; the complete response is obtained when the MADRS score has at least a 50% decrease after 6 weeks.
significant difference of activity duration between responder and non-responder	6 weeks
significant difference of RR interval of the heart rate between responder and non-responder	6 weeks

Trial Locations

Locations (1)

CHU Besancon; 🇫🇷 Besancon, Doubs, France