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Rhythm and Depression

Characterization of Rhythmic Markers Associated With the Response to Antidepressants

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02857036
Acronym
R&B
Enrollment
80
Registered
2016-08-05
Start date
2013-07-31
Completion date
2018-10-31
Last updated
2017-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

rhythm, depression, antidepressant treatment

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.

Interventions

OTHERrhythmic parameter recording

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)

Sponsors

Centre Hospitalier Universitaire Dijon
CollaboratorOTHER
University Hospital, Strasbourg, France
CollaboratorOTHER
Centre Hospitalier Universitaire de Besancon
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
significant difference of temperature amplitude between responder and non-responder6 weeksthe 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-responder6 weeks
significant difference of RR interval of the heart rate between responder and non-responder6 weeks

Countries

France

Contacts

Primary Contactjulie monnin, PhD
jmonnin@chu-besancon.fr0033381218543
Backup ContactSophie Depierre
sdepierre@chu-besancon.fr0033381218745

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026