Bipolar DisorderMONARCANCT01446406
The MONARCA Project (MONitoring, treAtment and pRediCtion of bipolAr Disorder Episodes)
A study testing MONARCA and NON-MONARCA in people with Bipolar Disorder, run by Psychiatric Centre Rigshospitalet at 1 site in Denmark.
Trial summary
Bipolar disorder is associated with a high risk of relapse and hospitalisation and many patients do not recover to previous psychosocial function. Major reasons for poor outcome are delayed intervention for prodromal depressive and manic episodes as well as decreased adherence with treatment. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- MONARCA and NON-MONARCA
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2011to Aug 2014
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of Bipolar disorder
- Hamilton Depression Scale under or equal to 17
- Young Mania Rating Scale under or equal to 17
Who cannot join
- Significant somatic disease
- Other severe mental illness (schizophrenia, schizoaffective disorder)
- Lack of technical skills
- Lack of knowledge of Danish
- Pregnancy
- Lack of desire/willingness to use the delivered cell phone as primary phone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electronic Daily Self-monitoring of Subjective and Objective Symptoms in Bipolar Disorder - The MONARCA Project (MONitoring, treAtment and pRediCtion of bipolAr Disorder Episodes)
Bipolar disorder is associated with a high risk of relapse and hospitalisation and many patients do not recover to previous psychosocial function. Major reasons for poor outcome are delayed intervention for prodromal depressive and manic episodes as well as decreased adherence with treatment. Recently, electronic self monitoring of affective symptoms using cell phones to prompt patients to respond to weekly text messages has been suggested as an easy and cheap way to identify early signs of affective episodes. Nevertheless, so far the electronic devises has been rather simple not including a bi-directional feed back loop between patients and providers and without electronic data on "objective" measures of the affective psychopathology. As part of an ongoing EU research program a software program for online electronic self-monitoring using a cell phone is being developed including an interactive feed back loop between patients, relatives and clinicians. Electronic self-monitoring includes subjective items such as mood, irritability, sleep duration, activity, alcohol consumption, medication intake and objective items of speech duration (on the cell phone), social activity (numbers of calls and SMS'es at the cell phone) and physical activity (acceleration of the cell phone). The present PhD. study will in a randomized controlled single blind trial including 60 patients with bipolar disorder allocated to using the active cell phone program (intervention group) or to using a cell phone to usual communication (control group) during a 6 months study period.
If the cell phone self-monitoring system is proved effective in preventing mood symptoms and improving psychosocial functioning,quality of life etc. in the present study there might be basis for extending the use of the system to treatment of patients with bipolar disorder in clinical practice in general.
Read the detailed description
The objectives of the study are to investigate in a randomised controlled single blind trial whether the use of an online monitoring system in patients suffering from bipolar disorder reduces symptoms of affective disorder.
As part of the clinical assessment in the Mood Disorder clinic, a paper version with daily monitoring of subjective items has been in use for four years. Based on an interactive process with patients suffering from bipolar disorder, the literature as well as clinical experience of the research and clinical group involved in the study we have chosen to monitor the following subjective items: mood, activity, irritability, sleep duration, alcohol consumption, medication intake. Patients are prompted to evaluate these items every evening. In the same way, the following objective items will be collected on all cell phones used in the study: speech duration (minutes speech per 24 hours on the cell phone), social activity (numbers of calls and SMS'es per 24 hours at the cell phone and acceleration of the cell phone).
A personal homepage for each patient is set op on a server so the patient can connect to the homepage with his cell phone using secure codes. By giving informed consent to participate in the MONARCA trial patients allow clinicians to connect to the homepage. It is optionally whether patients allow relatives (or others) to get access to the homepage. Online programs present the monitored subjective items as well as speech duration and number of calls and SMS's graphically.
It is not known whether using a cell phone for electronic monitoring of bipolar disorder the way described above improve outcome compared to using a cell phone to usual communication. A total of 60 patients with bipolar disorder are randomised (1:1) to using the active cell phone program (intervention group) or to using a cell phone to usual communication (control group). All randomised patients will receive a cell phone (Android) for use during the study period.
Stratification is done for age (18-30 versus 30-60 years) and prior hospitalisations (none versus hospitalisation). Study period: 6 months
The assessments are done by the PhD.-student who is not involved in the treatment of the randomised patients and is blinded versus having received the intervention system or the control system. All participants in the study will be examined every month by the PhD student for the entire study period. The following will be done: The bipolar diagnosis is confirmed by a SCAN interview. Further the following ratings/questionnaires are performed every month for 6 months: Hamilton Depression Scale-17 items (HAMD-17), the Young Mania Rating Scale (YMRS), psychosocial functioning (FAST), Cohen's Perceived stress scale, quality of life (WHOQOL), coping strategies (CISS), Altman Self-rating mania scale, Major Depression Inventory (MDI). Assessment of cognitive function (SCIP and Massachusetts General Hospital Questionnaire), awakening salivary cortisol, urinary oxidative stress, adherence to medication (plasma values of medication) and plasma BDNF are measured at start, half way and end of the study.
All assessment is done single blind, i.e., the assessor (researcher) does not know whether the patient is randomized to the intervention group or the control group.
The outcomes are differences between intervention and control group in:
- Primary: depressive and manic symptoms
- Secondary: psychosocial functioning, quality of life, perceived stress, coping strategies,adherence to medication, cognitive function, awakening salivary cortisol, urinary oxidative stress, plasma BDNF, physical activity, self-rated depressive and manic symptoms
- Conditions
- Bipolar Disorder
- Being tested
- MONARCA, NON-MONARCA
- Keywords
- Bipolar disorder, Electronic daily monitoring, Affective episodes
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MONARCADevice
Also called Electronic self-monitoring
Monitoring affective symptoms entered by the patient every day.
NON-MONARCADevice
A mobile phone for communication purposes only. No application has been installed.
| Study group | Role | What they receive |
|---|---|---|
| MONARCA | Active comparator | MONARCA self-monitoring application on a cell phone to monitor affective symptoms every day. Receives: Device: MONARCA |
| NON-MONARCA | Placebo comparator | This is the same mobile phone as the MONARCA mobile phone. Yet the MONARCA application has not been installed. The mobile phone can only be used as a normal mobile phone for communication purposes. Receives: Device: NON-MONARCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in Hamilton Depression Rating Scale (HAM-D17) score and Young Mania Rating Scale (YMRS) score during the entire 6 months study period.
The differences in scores on HAM-D17 and YMRS in the areas under the curves between the intervention and the control group.
Measured: Measured on all participants included one time a month for six months
Secondary outcomes (1)
Psychosocial Functioning (Functioning Assessment Short Test, FAST)
Differences between the two groups in: psychosocial functioning, quality of life, perceived stress, coping strategies,adherence to medication, cognitive function, awakening salivary cortisol, urinary oxidative stress, plasma BDNF, physical activity, self-rated depressive and manic symptoms (secondary)
Measured: Measured every month for 6 months on all participants
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Psychiatric Centre Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, IT University of Copenhagen, Seventh Framework Programme
- Responsible party
- Principal investigator, Maria Faurholt-Jepsen, Psychiatric Centre Rigshospitalet
- Investigators
- Maria Faurholt-Jepsen, MD, Principal investigator, Department of psychiatry, Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01446406
- Sponsor's protocol ID
- H-2-2011-056
- Acronym
- MONARCA
- Status last verified
- Mar 2016
- First submitted
- 26 Sep 2011
- Last updated
- 30 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Faurholt-Jepsen M, Frost M, Christensen EM, Bardram JE, Vinberg M, Kessing LV. Validity and characteristics of patient-evaluated adherence to medication via smartphones in patients with bipolar disorder: exploratory reanalyses on pooled data from the MONARCA I and II trials. Evid Based Ment Health. 2020 Feb;23(1):2-7. doi: 10.1136/ebmental-2019-300106.
PubMed 32046986Faurholt-Jepsen M, Vinberg M, Christensen EM, Frost M, Bardram J, Kessing LV. Daily electronic self-monitoring of subjective and objective symptoms in bipolar disorder--the MONARCA trial protocol (MONitoring, treAtment and pRediCtion of bipolAr disorder episodes): a randomised controlled single-blind trial. BMJ Open. 2013 Jul 24;3(7):e003353. doi: 10.1136/bmjopen-2013-003353. Print 2013.
PubMed 23883891
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Daily Self-monitoring of Subjective and Objective Symptoms in Bipolar Disorder - The MONARCA Project (MONitoring, treAtment and pRediCtion of bipolAr Disorder Episodes)
- ClinicalTrials.gov ID
- NCT01446406
- Acronym / sponsor ID
- MONARCA / H-2-2011-056
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar disorder, Electronic daily monitoring, Affective episodes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Psychiatric Centre RigshospitaletUniversity, hospital or other
- Collaborators
- University of Copenhagen, IT University of Copenhagen, Seventh Framework Programme
- Study start
- Oct 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 5 Oct 2011 (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.
Bipolar disorder is associated with a high risk of relapse and hospitalisation and many patients do not recover to previous psychosocial function. Major reasons for poor outcome are delayed intervention for prodromal depressive and manic episodes as well as decreased adherence with treatment. Recently, electronic self monitoring of affective symptoms using cell phones to prompt patients to respond to weekly text messages has been suggested as an easy and cheap way to identify early signs of affective episodes. Nevertheless, so far the electronic devises has been rather simple not including a bi-directional feed back loop between patients and providers and without electronic data on "objective" measures of the affective psychopathology. As part of an ongoing EU research program a software program for online electronic self-monitoring using a cell phone is being developed including an interactive feed back loop between patients, relatives and clinicians. Electronic self-monitoring includes subjective items such as mood, irritability, sleep duration, activity, alcohol consumption, medication intake and objective items of speech duration (on the cell phone), social activity (numbers of calls and SMS'es at the cell phone) and physical activity (acceleration of the cell phone). The present PhD. study will in a randomized controlled single blind trial including 60 patients with bipolar disorder allocated to using the active cell phone program (intervention group) or to using a cell phone to usual communication (control group) during a 6 months study period.
If the cell phone self-monitoring system is proved effective in preventing mood symptoms and improving psychosocial functioning,quality of life etc. in the present study there might be basis for extending the use of the system to treatment of patients with bipolar disorder in clinical practice in general.
Detailed description
The objectives of the study are to investigate in a randomised controlled single blind trial whether the use of an online monitoring system in patients suffering from bipolar disorder reduces symptoms of affective disorder.
As part of the clinical assessment in the Mood Disorder clinic, a paper version with daily monitoring of subjective items has been in use for four years. Based on an interactive process with patients suffering from bipolar disorder, the literature as well as clinical experience of the research and clinical group involved in the study we have chosen to monitor the following subjective items: mood, activity, irritability, sleep duration, alcohol consumption, medication intake. Patients are prompted to evaluate these items every evening. In the same way, the following objective items will be collected on all cell phones used in the study: speech duration (minutes speech per 24 hours on the cell phone), social activity (numbers of calls and SMS'es per 24 hours at the cell phone and acceleration of the cell phone).
A personal homepage for each patient is set op on a server so the patient can connect to the homepage with his cell phone using secure codes. By giving informed consent to participate in the MONARCA trial patients allow clinicians to connect to the homepage. It is optionally whether patients allow relatives (or others) to get access to the homepage. Online programs present the monitored subjective items as well as speech duration and number of calls and SMS's graphically.
It is not known whether using a cell phone for electronic monitoring of bipolar disorder the way described above improve outcome compared to using a cell phone to usual communication. A total of 60 patients with bipolar disorder are randomised (1:1) to using the active cell phone program (intervention group) or to using a cell phone to usual communication (control group). All randomised patients will receive a cell phone (Android) for use during the study period.
Stratification is done for age (18-30 versus 30-60 years) and prior hospitalisations (none versus hospitalisation). Study period: 6 months
The assessments are done by the PhD.-student who is not involved in the treatment of the randomised patients and is blinded versus having received the intervention system or the control system. All participants in the study will be examined every month by the PhD student for the entire study period. The following will be done: The bipolar diagnosis is confirmed by a SCAN interview. Further the following ratings/questionnaires are performed every month for 6 months: Hamilton Depression Scale-17 items (HAMD-17), the Young Mania Rating Scale (YMRS), psychosocial functioning (FAST), Cohen's Perceived stress scale, quality of life (WHOQOL), coping strategies (CISS), Altman Self-rating mania scale, Major Depression Inventory (MDI). Assessment of cognitive function (SCIP and Massachusetts General Hospital Questionnaire), awakening salivary cortisol, urinary oxidative stress, adherence to medication (plasma values of medication) and plasma BDNF are measured at start, half way and end of the study.
All assessment is done single blind, i.e., the assessor (researcher) does not know whether the patient is randomized to the intervention group or the control group.
The outcomes are differences between intervention and control group in:
- Primary: depressive and manic symptoms
- Secondary: psychosocial functioning, quality of life, perceived stress, coping strategies,adherence to medication, cognitive function, awakening salivary cortisol, urinary oxidative stress, plasma BDNF, physical activity, self-rated depressive and manic symptoms
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MONARCA | Active comparator | Device: MONARCAMONARCA self-monitoring application on a cell phone to monitor affective symptoms every day. |
| NON-MONARCA | Placebo comparator | Device: NON-MONARCAThis is the same mobile phone as the MONARCA mobile phone. Yet the MONARCA application has not been installed. The mobile phone can only be used as a normal mobile phone for communication purposes. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosis of Bipolar disorder
- Hamilton Depression Scale under or equal to 17
- Young Mania Rating Scale under or equal to 17
Key exclusion criteria (6 listed)
- Significant somatic disease
- Other severe mental illness (schizophrenia, schizoaffective disorder)
- Lack of technical skills
- Lack of knowledge of Danish
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MONARCAAlso: Electronic self-monitoringMonitoring affective symptoms entered by the patient every day. | Device | MONARCA |
| NON-MONARCAA mobile phone for communication purposes only. No application has been installed. | Device | NON-MONARCA |
Primary outcome
Differences in Hamilton Depression Rating Scale (HAM-D17) score and Young Mania Rating Scale (YMRS) score during the entire 6 months study period.
Time frame: Measured on all participants included one time a month for six months
The differences in scores on HAM-D17 and YMRS in the areas under the curves between the intervention and the control group.
1 secondary outcome
Psychosocial Functioning (Functioning Assessment Short Test, FAST)
Time frame: Measured every month for 6 months on all participants
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2016.
- Derived from this study: PubMed 32046986Faurholt-Jepsen M, Frost M, Christensen EM, Bardram JE, Vinberg M, Kessing LV. Validity and characteristics of patient-evaluated adherence to medication via smartphones in patients with bipolar disorder: exploratory reanalyses on pooled data from the MONARCA I and II trials. Evid Based Ment Health. 2020 Feb;23(1):2-7. doi: 10.1136/ebmental-2019-300106.
- Derived from this study: PubMed 23883891Faurholt-Jepsen M, Vinberg M, Christensen EM, Frost M, Bardram J, Kessing LV. Daily electronic self-monitoring of subjective and objective symptoms in bipolar disorder--the MONARCA trial protocol (MONitoring, treAtment and pRediCtion of bipolAr disorder episodes): a randomised controlled single-blind trial. BMJ Open. 2013 Jul 24;3(7):e003353. doi: 10.1136/bmjopen-2013-003353. Print 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.
Maria Faurholt-Jepsen, MD principal investigator
Department of psychiatry, Copenhagen, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MONARCA and NON-MONARCA in people with Bipolar Disorder, run by Psychiatric Centre Rigshospitalet at 1 site in Denmark.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 30 Mar 2016. 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 Denmark. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in Hamilton Depression Rating Scale (HAM-D17) score and Young Mania Rating Scale (YMRS) score during the entire 6 months study period. (time frame: Measured on all participants included one time a month for six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01446406, which also lists 2 linked publications.
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 30 Mar 2016.