Rhythm and Depression (R&B)

Centre Hospitalier Universitaire de Besancon

Status: Unknown

Conditions: Depression

Treatments: Other: rhythmic parameter recording; Behavioral: psychiatric assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT02857036

P/2011/120

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

responder

Experimental group

Description:

responder to antidepressant treatment

Treatment:

Behavioral: psychiatric assessment

Other: rhythmic parameter recording

non responder

Experimental group

Description:

non responder to antidepressant treatment

Treatment:

Behavioral: psychiatric assessment

Other: rhythmic parameter recording