Rhythm and Depression

Depression Clinical Trial

— R&B  

Official title:

Characterization of Rhythmic Markers Associated With the Response to Antidepressants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02857036
• Other study ID #: P/2011/120
• Status: Recruiting
• Phase: N/A
• First received: August 2, 2016
• Last updated: February 28, 2017
• Start date: July 2013
• Est. completion date: October 2018

Study information

• Verified date: February 2017
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: julie monnin, PhD
• Phone: 0033381218543
• Email: jmonnin[@]chu-besancon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Other:
• rhythmic parameter recording
the following rhythmic parameters are recording during 48 hours: temperature, heart rate and actimetry

Behavioral:
• psychiatric assessment
different psychometric scales are filled in: Montgomery and Asberg depression rating scale (MADRS), Quick inventory depression scale (QIDS-C16) and Beck depression inventory (BDI)

Locations

Country	Name	City	State
France	CHU Besancon	Besancon	Doubs

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon	Centre Hospitalier Universitaire Dijon, University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	significant difference of temperature amplitude between responder and non-responder	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.	6 weeks
Primary	significant difference of activity duration between responder and non-responder		6 weeks
Primary	significant difference of RR interval of the heart rate between responder and non-responder		6 weeks