Rhythm and Depression

NCT ID: NCT02857036

Last Updated: 2017-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2018-10-31

Brief Summary

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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

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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.

Conditions

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Depression

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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responder

responder to antidepressant treatment

Group Type EXPERIMENTAL

rhythmic parameter recording

Intervention Type OTHER

the following rhythmic parameters are recording during 48 hours: temperature, heart rate and actimetry

psychiatric assessment

Intervention Type BEHAVIORAL

different psychometric scales are filled in: Montgomery and Asberg depression rating scale (MADRS), Quick inventory depression scale (QIDS-C16) and Beck depression inventory (BDI)

non responder

non responder to antidepressant treatment

Group Type EXPERIMENTAL

rhythmic parameter recording

Intervention Type OTHER

the following rhythmic parameters are recording during 48 hours: temperature, heart rate and actimetry

psychiatric assessment

Intervention Type BEHAVIORAL

different psychometric scales are filled in: Montgomery and Asberg depression rating scale (MADRS), Quick inventory depression scale (QIDS-C16) and Beck depression inventory (BDI)

Interventions

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rhythmic parameter recording

the following rhythmic parameters are recording during 48 hours: temperature, heart rate and actimetry

Intervention Type OTHER

psychiatric assessment

different psychometric scales are filled in: Montgomery and Asberg depression rating scale (MADRS), Quick inventory depression scale (QIDS-C16) and Beck depression inventory (BDI)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role collaborator

University Hospital, Strasbourg, France

OTHER

Sponsor Role collaborator

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emmanuel Haffen, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Besancon

Locations

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CHU Besancon

Besançon, Doubs, France

Site Status RECRUITING

Countries

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France

Central Contacts

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julie monnin, PhD

Role: CONTACT

0033381218543

Sophie Depierre

Role: CONTACT

0033381218745

Facility Contacts

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Julie Monnin, PhD

Role: primary

00033381218543

Other Identifiers

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P/2011/120

Identifier Type: -

Identifier Source: org_study_id

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