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Bipolar DisorderMONARCAIINCT02221336

Daily Subjective and Objective Smartphone Measures of Illness Activity to Treat Bipolar Disorder- The MONARCA II Trial

A study testing The MONARCA II system and Non-MONARCA II system in people with Bipolar Disorder, run by Psychiatric Centre Rigshospitalet at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Bipolar disorder is associated with a high risk of relapse and hospitalisation and many patients do not recover to their previous psychosocial function. Major reasons for poor outcomes are delayed intervention for prodromal depressive and manic symptoms as well as decreased adherence with treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bipolar Disorder
What is being tested?
The MONARCA II system and Non-MONARCA II system
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
146 participants
Where
1 siteDenmark
Study dates
Sep 2014to Jan 2018
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Bipolar Disorder according to SCAN interview
  • ≥18 years of age
  • Patients who previously have received a course of treatment at the Clinic for Affective Disorders, Psychiatric Centre Copenhagen, Denmark

Who cannot join

  • Pregnancy
  • Lack of Danish language skills
  • Patients who previously have received and used the MONARCA I system for self-monitoring

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Psychiatric Centre Copenhagen, Rigshospitalet

    Copenhagen, 2100

Other trials in Denmark

About this study

Official title: Daily Electronic Monitoring of Subjective and Objective Measures of Illness Activity in Bipolar Disorder - The MONARCA II Trial (MONitoring, treAtment and pRediCtion of bipolAr Disorder Episodes II)

Bipolar disorder is associated with a high risk of relapse and hospitalisation and many patients do not recover to their previous psychosocial function. Major reasons for poor outcomes are delayed intervention for prodromal depressive and manic symptoms as well as decreased adherence with treatment.

Recently, in the MONARCA I trial (NCT01446406), the investigators developed and deployed a smartphone based self-monitoring system (the MONARCA I system) in a randomized controlled trial, to test the effect of daily reporting of subjective self-monitoring of depressive and manic symptoms as well as a bi-directional feedback loop on depressive and manic symptoms.

In the MONARCA II trial the investigators will develop and deploy a new version of the smartphone based monitoring system. The investigators will in a randomized controlled single blind trial investigate whether daily electronic monitoring of subjective and objective measures of illness activity using a smartphone based self-monitoring system including feedback on subjective as well as automatically generated objective data (e.g.social activity, physical activity etc.) (the MONARCA II system) reduces the severity of depressive and manic symptoms and improves functioning more than a control group receiving a smartphone. All patients will be followed for 9 months with outcome assessments at baseline, after 4 weeks, after 3 months, after 6 months and after 9 months.

Being tested
The MONARCA II system, Non-MONARCA II system
Keywords
Bipolar disorder, Daily electronic monitoring, Smartphones, Subjective and objective smartphone data, Feedback loop
Medical subject headings
Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The MONARCA II systemDevice

    Also called Non-MONARCA II system (control group condition)

    Daily electronic monitoring of subjective and objective smartphone measures including a feedback loop

  • Non-MONARCA II systemDevice

    Daily use of smartphone for normal communicative purposes. No self-monitoring in the MONARCA II system.

Study groups in NCT02221336
Study groupRoleWhat they receive
Non-MONARCA II systemPlacebo comparatorUse of smartphone for normal communicative purposes only. No self-monitoring and no feedback loop.
Receives: Device: Non-MONARCA II system
The MONARCA II systemExperimentalDaily electronic monitoring of subjective and objective smartphone measures including a feedback loop
Receives: Device: The MONARCA II system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Differences between the groups in depressive and manic symptoms and the number of affective episodes

    Differences between the groups in depressive and manic symptoms measured using Hamilton Depression Rating Scale (HDRS) and Young Mania Rating Scale (YMRS) and episodes defined ad HDRS<= 14 and/or YMRS<= 14

    Measured: Baseline and up to 9 months

Secondary outcomes (11)

  1. Differences between the groups in smartphone measures

    Differences between the groups in:

    -Automatically generated objective smartphone measures

    Measured: Baseline and up to 9 months

  2. Differences between the groups in number of hospitalizations

    Differences between the groups in number of hospitalization

    Measured: Baseline up to 9 months follow up

  3. Differences between the groups in number of contacts to clinicians and emergency rooms

    Differences between the groups in number of contacts to clinicians and emergency rooms

    Measured: Baseline up to 9 months follow up

  4. Differences between the groups in functioning

    Differences between the groups in functioning measured using the FAST questionnaire

    Measured: Baseline up to 9 months follow up

  5. Differences between the groups in perceived stress

    Differences between the groups in perceived stress using the perceived stress questionnaire

    Measured: Baseline up to 9 months

  6. Differences between the groups in quality of life

    Differences between the groups in quality of life measured using the WHOQoL questionnaire

    Measured: Baseline up to 9 months follow up

  7. Differences between the groups in self-rated depressive symptoms

    Differences between the groups in self-rated depresisve symptoms using the BDI questionnaire

    Measured: Baseline up to 9 months

  8. Differences in self-rated manic symptoms

    Differences between the groups in self-rated manic symptoms using the ASRM questionnaire

    Measured: Baseline up to 9 months follow up

  9. Differences between the groups in adherence to medication

    Differences between the groups in adherence to medication measured using the questionnaire MARS

    Measured: Baseline up to 9 months follow up

  10. Differences between the groups in recovery

    Differences between the groups in recovery using the questionnaire Recovery Assessment Scale (RAS)

    Measured: Baseline up to 9 months follow up

  11. Differences between the groups in empowerment

    Differences between the groups in empowerment using the questionnaire Rogers Empowerment scale.

    Measured: baseline up ot 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionJan 2018
  4. Study completionJan 2018

Resources

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
146 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02221336
Sponsor's protocol ID
H-2-2014-059
Acronym
MONARCAII
Status last verified
Apr 2018
First submitted
12 Aug 2014
Last updated
6 Apr 2018
Results posted
No
Data monitoring committee
No

Publications

  • Faurholt-Jepsen M, Frost M, Vinberg M, Christensen EM, Bardram JE, Kessing LV. Smartphone data as objective measures of bipolar disorder symptoms. Psychiatry Res. 2014 Jun 30;217(1-2):124-7. doi: 10.1016/j.psychres.2014.03.009. Epub 2014 Mar 13.

    PubMed 24679993

  • Faurholt-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

  • 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 32046986

  • Faurholt-Jepsen M, Frost M, Busk J, Christensen EM, Bardram JE, Vinberg M, Kessing LV. Differences in mood instability in patients with bipolar disorder type I and II: a smartphone-based study. Int J Bipolar Disord. 2019 Feb 1;7(1):5. doi: 10.1186/s40345-019-0141-4.

    PubMed 30706154

  • Faurholt-Jepsen M, Vinberg M, Frost M, Christensen EM, Bardram J, Kessing LV. Daily electronic monitoring of subjective and objective measures of illness activity in bipolar disorder using smartphones--the MONARCA II trial protocol: a randomized controlled single-blind parallel-group trial. BMC Psychiatry. 2014 Nov 25;14:309. doi: 10.1186/s12888-014-0309-5.

    PubMed 25420431

Questions about this trial

What is this clinical trial studying?

A study testing The MONARCA II system and Non-MONARCA II system 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 3 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 6 Apr 2018. 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 between the groups in depressive and manic symptoms and the number of affective episodes (time frame: Baseline and up to 9 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 NCT02221336, which also lists 5 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 6 Apr 2018.

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