Rhythm and Depression

Study Overview
=================
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.

Official Title
-----------------
Characterization of Rhythmic Markers Associated With the Response to Antidepressants

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Other: rhythmic parameter recording
* Behavioral: psychiatric assessment


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: responder<br>responder to antidepressant treatment | Other: rhythmic parameter recording<br>* the following rhythmic parameters are recording during 48 hours: temperature, heart rate and actimetry<br>Behavioral: psychiatric assessment<br>* different psychometric scales are filled in: Montgomery and Asberg depression rating scale (MADRS), Quick inventory depression scale (QIDS-C16) and Beck depression inventory (BDI)<br>|
| Experimental: non responder<br>non responder to antidepressant treatment | Other: rhythmic parameter recording<br>* the following rhythmic parameters are recording during 48 hours: temperature, heart rate and actimetry<br>Behavioral: psychiatric assessment<br>* different psychometric scales are filled in: Montgomery and Asberg depression rating scale (MADRS), Quick inventory depression scale (QIDS-C16) and Beck depression inventory (BDI)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rhythm, depression, antidepressant treatment