PSYCHE (Personalised Monitoring SYstems for Care in Mental Health)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University Hospital, Strasbourg, France
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT01879982
First received: March 22, 2013
Last updated: June 13, 2013
Last verified: June 2013
  Purpose

For the moment, the detection of a mood episode in Bipolar Disorder (BD) relies on the appearance of the first clinical signs that the clinician detect or that the patient becomes aware of and reports to the clinician. Since physiological parameters such as cardiac rhythms, respiratory rate, voice characteristics and actigraphy seem to be related to the onset of a mood episode, information collected through the combined monitoring of multiple selected physiological parameters (such as cardiac rhythms, respiratory rate, movements, voice) during wake and sleep time, using wearable user friendly systems included into garments as well as with a smartphone, may offer a new perspective in the long-term treatment of BD.


Condition
Bipolar Disorder I
Bipolar Disorder II
Rapid Cycling Bipolar Disorder(DSM-IV-TR)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Personal Wearable and Interactive System for Monitoring and Multivariable Physiological Assessment to Predict Mood Changes: a Pilot Study With Cyclothymic and Rapid Cycling Bipolar Subjects

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • detect and predict mood changes in cyclothymic subjects and in rapid cycling subjects [ Time Frame: 14-week study assessment ] [ Designated as safety issue: No ]
    recording heart rate, respiratory rate and body activity with a wearable device ("Wearable Wellness System" or WWS), and by analysing subject's voice through a voice analysis system embedded in a smartphone.


Secondary Outcome Measures:
  • tolerability and acceptability of the regular use of PSYCHE multiparameter platform (WWS and the smartphone)and the feasibility and the different functionalities of the different components of the PSYCHE system in a field trial [ Time Frame: 14-week assessment study ] [ Designated as safety issue: No ]

    Evaluation criteria will be :

    1. Subjective : the proportions of subjects with tolerance problems and with acceptance of future use, for the different components of the system, as assessed with the end-of-study criteria or as reported at the end of the visits on the basis of an open question ;
    2. Objective: the proportion of missing appointments (daily and biweekly recordings) . Evaluation criteria will be :

    1) Subjective : the proportions of subjects with tolerance problems and with acceptance of future use, for the different components of the system, as assessed with the end-of-study criteria or as reported at the end of the visits on the basis of an open question ; 2) Objective: the proportion of missing appointments (daily and biweekly recordings) 3) Evaluation criteria will be the estimated frequencies and types of technical and professional user problems during the study (according to a qualitative methodology)



Estimated Enrollment: 8
Study Start Date: May 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Wellness Wearable System & Smartphone

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Individuals with cyclothymia or with rapid cycling BD will be recruited in the general population via ads in newspapers and universities (psychology, medical, and arts departments, for instance) and in clinical populations (patients from the investigators).

Criteria

Inclusion Criteria:

  1. Male and female individuals aged from 18 to 65 years old (both ages included).
  2. Participants meeting DSM-IV-TR criteria for bipolar disorder I or II subtypes or Participants meeting DSM-IV-TR criteria for rapid cycling BD, which is defined by a pattern of presentation accompanied by 4 or more mood episodes in a 12-month period, with a typical course of mania or hypomania followed by depression or vice versa. The episodes must be demarcated by a full or partial remission lasting at least 2 months or by a switch to a mood state of opposite polarity.
  3. Female participants must agree to use efficient contraceptive methods during the study duration.
  4. Participants must have signed informed consent documents indicating that they understand the purpose and procedures required for the study and are willing to participate in the study and comply with the study procedures and restrictions.
  5. Patients must be affiliated with or a beneficiary of a social security system.

Exclusion Criteria:

  1. Any clinically relevant acute or chronic diseases which could interfere with the participants' safety during the trial, or expose them to undue risk or which could interfere with the study objective. This last perspective includes :- Attention deficit and hyperactivity disorder (ADHD)- Borderline personality disorder (BPD)
  2. Current MDD episode or manic episode, according to the DSM-IV-TR criteria
  3. Current major suicidal ideation (suicidal thoughts several times a day)
  4. History of recent (less than 1 year preceding inclusion) substance abuse or dependence (tobacco dependence excepted)
  5. Pregnant women as determined by the patient or breast-feeding women
  6. Any history of significant allergy.
  7. No legal capacity or limited legal capacity or unable to give an informed consent.
  8. Participants unlikely to co-operate in the study, and/or poor compliance anticipated by the investigator
  9. Participants being in the exclusion period according to the French National File for participants participating in a biomedical research.
  10. Total annual amount of compensation earned from participating in clinical studies exceeding 4500 Euros.
  11. Patients with pacemaker, defibrillator, or any implanted electronic device (to avoid any hazard - see section 7.3.2 of the Psyche device User Manual).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01879982

Locations
France
Service de Psychiatrie II - Hôpitaux Universitaires de Strasbourg Recruiting
Strasbourg, Alsace, France, 67 091
Contact: Gilles Bertschy, Pr    03 88 11 65 48    gilles.bertschy@chru-strasbourg.fr   
Contact: Javelot Hervé, Dr    03 88 11 65 11    herve.javelot@chru-strasbourg.fr   
Sub-Investigator: Sébastien Weibel, Dr         
Principal Investigator: Gilles Bertschy, Pr         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Bertschy Gilles, MD Service de Psychiatrie II - Hôpitaux Universitaires de Strasbourg
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT01879982     History of Changes
Other Study ID Numbers: 2012-A00725-38
Study First Received: March 22, 2013
Last Updated: June 13, 2013
Health Authority: France : ANSM

Keywords provided by University Hospital, Strasbourg, France:
Bipolar disorder
subtypes

Additional relevant MeSH terms:
Bipolar Disorder
Disease
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014