Bipolar Disorder IPSYCHENCT01879982
PSYCHE (Personalised Monitoring SYstems for Care in Mental Health)
An observational study of Bipolar Disorder I and Bipolar Disorder II, run by University Hospital, Strasbourg, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder I, Bipolar Disorder II, Rapid Cycling Bipolar Disorder(DSM-IV-TR)
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- May 2013to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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)
- History of recent (less than 1 year preceding inclusion) substance abuse or dependence (tobacco dependence excepted)
- Pregnant women as determined by the patient or breast-feeding women
- Any history of significant allergy.
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- 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
- Participants being in the exclusion period according to the French National File for participants participating in a biomedical research.
- 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).
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Psychiatrie II - Hôpitaux Universitaires de Strasbourg
Strasbourg, Alsace, 67 091
Gilles Bertschy, Pr, 03 88 11 65 48, gilles.bertschy@chru-strasbourg.fr
Javelot Hervé, Dr, 03 88 11 65 11, herve.javelot@chru-strasbourg.fr
About this study
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
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.
- Keywords
- Bipolar disorder, subtypes
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Wellness Wearable System & Smartphone | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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 :
- 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)
Measured: 14-week assessment study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar Disorder IStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bertschy Gilles, MD, Principal investigator, Service de Psychiatrie II - Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01879982
- Sponsor's protocol ID
- 2012-A00725-38
- Acronym
- PSYCHE
- Status last verified
- Jun 2013
- First submitted
- 22 Mar 2013
- Last updated
- 18 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01879982
- Acronym / sponsor ID
- PSYCHE / 2012-A00725-38
- Keywords
- Bipolar disorder, subtypes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Dec 2013 (estimated)
- First posted
- 18 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wellness Wearable System & Smartphone | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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)
- History of recent (less than 1 year preceding inclusion) substance abuse or dependence (tobacco dependence excepted)
- Pregnant women as determined by the patient or breast-feeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Service de Psychiatrie II - Hôpitaux Universitaires de Strasbourg
Strasbourg, France
Bertschy Gilles, MD principal investigator
Service de Psychiatrie II - Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder I and Bipolar Disorder II, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detect and predict mood changes in cyclothymic subjects and in rapid cycling subjects (time frame: 14-week study assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2013.