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Rhythm and Depression (R&B)

Primary Purpose

Depression

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
rhythmic parameter recording
psychiatric assessment
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Depression focused on measuring rhythm, depression, antidepressant treatment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU BesanconRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

responder

non responder

Arm Description

responder to antidepressant treatment

non responder to antidepressant treatment

Outcomes

Primary Outcome Measures

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.
significant difference of activity duration between responder and non-responder
significant difference of RR interval of the heart rate between responder and non-responder

Secondary Outcome Measures

Full Information

First Posted
August 2, 2016
Last Updated
February 28, 2017
Sponsor
Centre Hospitalier Universitaire de Besancon
Collaborators
Centre Hospitalier Universitaire Dijon, University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT02857036
Brief Title
Rhythm and Depression
Acronym
R&B
Official Title
Characterization of Rhythmic Markers Associated With the Response to Antidepressants
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
October 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon
Collaborators
Centre Hospitalier Universitaire Dijon, University Hospital, Strasbourg, France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
rhythm, depression, antidepressant treatment

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
responder
Arm Type
Experimental
Arm Description
responder to antidepressant treatment
Arm Title
non responder
Arm Type
Experimental
Arm Description
non responder to antidepressant treatment
Intervention Type
Other
Intervention Name(s)
rhythmic parameter recording
Intervention Description
the following rhythmic parameters are recording during 48 hours: temperature, heart rate and actimetry
Intervention Type
Behavioral
Intervention Name(s)
psychiatric assessment
Intervention Description
different psychometric scales are filled in: Montgomery and Asberg depression rating scale (MADRS), Quick inventory depression scale (QIDS-C16) and Beck depression inventory (BDI)
Primary Outcome Measure Information:
Title
significant difference of temperature amplitude between responder and non-responder
Description
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.
Time Frame
6 weeks
Title
significant difference of activity duration between responder and non-responder
Time Frame
6 weeks
Title
significant difference of RR interval of the heart rate between responder and non-responder
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
julie monnin, PhD
Phone
0033381218543
Email
jmonnin@chu-besancon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Sophie Depierre
Phone
0033381218745
Email
sdepierre@chu-besancon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuel Haffen, MD PhD
Organizational Affiliation
Centre Hospitalier Universitaire de Besancon
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Besancon
City
Besancon
State/Province
Doubs
ZIP/Postal Code
25030
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Monnin, PhD
Phone
00033381218543
Email
jmonnin@chu-besancon.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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Rhythm and Depression

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