Characterization of Rhythmic Markers Associated With the Response to Antidepressants
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- significant difference of temperature amplitude between responder and non-responder
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
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.
significant difference of activity duration between responder and non-responder
Time Frame: 6 weeks
significant difference of RR interval of the heart rate between responder and non-responder
Time Frame: 6 weeks
Secondary Outcomes
No secondary outcomes reported