PSYCHE (Personalised Monitoring SYstems for Care in Mental Health)

Bipolar Disorder I Clinical Trial

— PSYCHE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01879982
• Other study ID #: 2012-A00725-38
• Status: Recruiting
• Phase: N/A
• First received: March 22, 2013
• Last updated: June 13, 2013
• Start date: May 2013

Study information

• Verified date: June 2013
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France : ANSM
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
France	Service de Psychiatrie II - Hôpitaux Universitaires de Strasbourg	Strasbourg	Alsace

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	detect and predict mood changes in cyclothymic subjects and in rapid cycling subjects	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	No
Secondary	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	Evaluation criteria will be : 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 ; 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	No

External Links

•   psyche website