ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	16 December 2017
Main ID:	NCT02857036
Date of registration:	02/08/2016
Prospective Registration:	No
Primary sponsor:	Centre Hospitalier Universitaire de Besancon
Public title:	Rhythm and Depression R&B
Scientific title:	Characterization of Rhythmic Markers Associated With the Response to Antidepressants
Date of first enrolment:	July 2013
Target sample size:	80
Recruitment status:	Recruiting
URL:	https://clinicaltrials.gov/show/NCT02857036
Study type:	Interventional
Study design:	Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
Phase:	N/A

Countries of recruitment
France

Contacts

Name:	julie monnin, PhD
Address:
Telephone:	0033381218543
Email:	jmonnin@chu-besancon.fr
Affiliation:

Name:	Julie Monnin, PhD
Address:
Telephone:	00033381218543
Email:	jmonnin@chu-besancon.fr
Affiliation:

Name:	Emmanuel Haffen, MD PhD
Address:
Telephone:
Email:
Affiliation:	Centre Hospitalier Universitaire de Besancon

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Depression

Intervention(s)

Behavioral: psychiatric assessment

Other: rhythmic parameter recording

Primary Outcome(s)

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]

significant difference of temperature amplitude between responder and non-responder [Time Frame: 6 weeks]

Secondary Outcome(s)

Secondary ID(s)

P/2011/120

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University Hospital, Strasbourg, France

Centre Hospitalier Universitaire Dijon

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.