PSYCHE (Personalised Monitoring SYstems for Care in Mental Health)

NCT01879982 | Unknown

• 1 other identifier: 2012-A00725-38
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Bipolar disorder; subtypes

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

  14-week assessment study

Study Arms (1)

Wellness Wearable System & Smartphone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Male and female individuals aged from 18 to 65 years old (both ages included).
• 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.
• Female participants must agree to use efficient contraceptive methods during the study duration.
• 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.
• Patients must be affiliated with or a beneficiary of a social security system.

You may not qualify if:

• 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)
• Current MDD episode or manic episode, according to the DSM-IV-TR criteria
• Current major suicidal ideation (suicidal thoughts several times a day)
• Pregnant women as determined by the patient or breast-feeding women
• Any history of significant allergy.
• No legal capacity or limited legal capacity or unable to give an informed consent.
• Participants unlikely to co-operate in the study, and/or poor compliance anticipated by the investigator
• Total annual amount of compensation earned from participating in clinical studies exceeding 4500 Euros.
• Patients with pacemaker, defibrillator, or any implanted electronic device (to avoid any hazard - see section 7.3.2 of the Psyche device User Manual).

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service de Psychiatrie II - Hôpitaux Universitaires de Strasbourg

Strasbourg, Alsace, 67 091, France

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Bertschy Gilles, MD

  Service de Psychiatrie II - Hôpitaux Universitaires de Strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2013
• First Posted: June 18, 2013
• Study Start: May 1, 2013
• Primary Completion: December 1, 2013
• Last Updated: June 18, 2013

Record last verified: 2013-06

Locations

FR (1)