Rhythm and Depression (R&B)

February 28, 2017 updated by: Centre Hospitalier Universitaire de Besancon

Characterization of Rhythmic Markers Associated With the Response to Antidepressants

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.

Study Overview

Status

Unknown

Conditions

Intervention / 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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Doubs
      • Besancon, Doubs, France, 25030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: responder
responder to antidepressant treatment
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)
Experimental: non responder
non responder to antidepressant treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
significant difference of temperature amplitude between responder and non-responder
Time Frame: 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.
6 weeks
significant difference of activity duration between responder and non-responder
Time Frame: 6 weeks
6 weeks
significant difference of RR interval of the heart rate between responder and non-responder
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Collaborators

University Hospital, Strasbourg, France
Centre Hospitalier Universitaire Dijon

Investigators

  • Principal Investigator: Emmanuel HAFFEN, MD PhD, Centre Hospitalier Universitaire de Besancon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

October 1, 2018

Study Registration Dates

First Submitted

August 2, 2016

First Submitted That Met QC Criteria

August 2, 2016

First Posted (Estimate)

August 5, 2016

Study Record Updates

Last Update Posted (Actual)

March 1, 2017

Last Update Submitted That Met QC Criteria

February 28, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P/2011/120

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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