PSYCHE (Personalised Monitoring SYstems for Care in Mental Health) (PSYCHE)

June 13, 2013 updated by: University Hospital, Strasbourg, France

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

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Alsace
      • Strasbourg, Alsace, France, 67 091
        • Recruiting
        • Service de Psychiatrie II - Hôpitaux Universitaires de Strasbourg
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Sébastien Weibel, Dr
        • Principal Investigator:
          • Gilles Bertschy, Pr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Wellness Wearable System & Smartphone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
detect and predict mood changes in cyclothymic subjects and in rapid cycling subjects
Time Frame: 14-week study assessment
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.
14-week study assessment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

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)
14-week assessment study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: Bertschy Gilles, MD, Service de Psychiatrie II - Hôpitaux Universitaires de Strasbourg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

March 22, 2013

First Submitted That Met QC Criteria

June 13, 2013

First Posted (Estimate)

June 18, 2013

Study Record Updates

Last Update Posted (Estimate)

June 18, 2013

Last Update Submitted That Met QC Criteria

June 13, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-A00725-38

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bipolar Disorder I

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Suriname

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe