NCT02221336

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 20, 2014

Completed
12 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

April 6, 2018

Status Verified

April 1, 2018

Enrollment Period

3.3 years

First QC Date

August 12, 2014

Last Update Submit

April 5, 2018

Conditions

Bipolar Disorder

Keywords

Bipolar disorderDaily electronic monitoringSmartphonesSubjective and objective smartphone dataFeedback loop

Outcome Measures

Primary Outcomes (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

    Baseline and up to 9 months

Secondary Outcomes (11)

  • Differences between the groups in smartphone measures

    Baseline and up to 9 months

  • Differences between the groups in number of hospitalizations

    Baseline up to 9 months follow up

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

    Baseline up to 9 months follow up

  • Differences between the groups in functioning

    Baseline up to 9 months follow up

  • Differences between the groups in perceived stress

    Baseline up to 9 months

  • +6 more secondary outcomes

Study Arms (2)

Non-MONARCA II system

PLACEBO COMPARATOR

Use of smartphone for normal communicative purposes only. No self-monitoring and no feedback loop.

Device: Non-MONARCA II system

The MONARCA II system

EXPERIMENTAL

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

Device: The MONARCA II system

Interventions

The MONARCA II systemDEVICE

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

Also known as: Non-MONARCA II system (control group condition)
The MONARCA II system
Non-MONARCA II systemDEVICE

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

Non-MONARCA II system

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychiatric Centre Copenhagen, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (5)

  • 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.

    PMID: 24679993BACKGROUND

  • 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.

    PMID: 23883891BACKGROUND

  • 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.

    PMID: 32046986DERIVED

  • 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.

    PMID: 30706154DERIVED

  • 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.

    PMID: 25420431DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Officials

  • Maria Faurholt-Jepsen, MD

    Psychiatric Centre Copenhagen, Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, MD and PhD student

Study Record Dates

First Submitted

August 12, 2014

First Posted

August 20, 2014

Study Start

September 1, 2014

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

April 6, 2018

Record last verified: 2018-04

Locations

DK(1)