Clinical trial NCT01879982: PSYCHE (Personalised Monitoring SYstems for Care in Mental Health)
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bipolar Disorder I
Bipolar Disorder II
Rapid Cycling Bipolar Disorder(DSM-IV-TR)
Keywords: Bipolar disorder
subtypes
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2013-06-18
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

Brief 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.


Eligibility 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).

Primary outcomes:
measure: detect and predict mood changes in cyclothymic subjects and in rapid cycling subjects
timeFrame: 14-week study assessment
Secondary outcomes:
measure: 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
timeFrame: 14-week assessment study
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Psychiatrie II - Hôpitaux Universitaires de Strasbourg
state: Alsace
Study officials:
affiliation: Service de Psychiatrie II - Hôpitaux Universitaires de Strasbourg
name: Bertschy Gilles, MD
role: PRINCIPAL_INVESTIGATOR
References: