Rhythm and Depression
R&B
Characterization of Rhythmic Markers Associated With the Response to Antidepressants
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable depression
Started Jul 2013
Longer than P75 for not_applicable depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 2, 2016
CompletedFirst Posted
Study publicly available on registry
August 5, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedMarch 1, 2017
February 1, 2017
5.2 years
August 2, 2016
February 28, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Study Arms (2)
responder
EXPERIMENTALresponder to antidepressant treatment
non responder
EXPERIMENTALnon responder to antidepressant treatment
Interventions
the following rhythmic parameters are recording during 48 hours: temperature, heart rate and actimetry
different psychometric scales are filled in: Montgomery and Asberg depression rating scale (MADRS), Quick inventory depression scale (QIDS-C16) and Beck depression inventory (BDI)
Eligibility Criteria
You may qualify if:
- current unipolar major depressive disorder according to the Diagnostic ans Statistics Manual (DSM)V
- MADRS score \> 25
You may not qualify if:
- other psychiatric disorder
- current treatment with thymoregulating agent
- clozapine treatment
- heart disease that could alter heart rate characteristics
- disease associated with fever
- transmeridian travel in the preceding month
- guardianship
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Besancon
Besançon, Doubs, 25030, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emmanuel Haffen, MD PhD
Centre Hospitalier Universitaire de Besancon
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2016
First Posted
August 5, 2016
Study Start
July 1, 2013
Primary Completion
September 1, 2018
Study Completion
October 1, 2018
Last Updated
March 1, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share