The MONARCA Project (MONitoring, treAtment and pRediCtion of bipolAr Disorder Episodes)

NCT01446406 | Completed DMC

• 1 other identifier: H-2-2011-056
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Bipolar Disorder

Keywords

Bipolar disorder; Electronic daily monitoring; Affective episodes

Outcome Measures

Primary Outcomes (1)

• 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 on all participants included one time a month for six months

Secondary Outcomes (1)

• Psychosocial Functioning (Functioning Assessment Short Test, FAST)

  Measured every month for 6 months on all participants

Study Arms (2)

MONARCA

ACTIVE COMPARATOR

MONARCA self-monitoring application on a cell phone to monitor affective symptoms every day.

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.

Device: NON-MONARCA

Interventions

MONARCA DEVICE

Monitoring affective symptoms entered by the patient every day.

Also known as: Electronic self-monitoring

MONARCA

NON-MONARCA DEVICE

A mobile phone for communication purposes only. No application has been installed.

NON-MONARCA

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of Bipolar disorder
• Hamilton Depression Scale under or equal to 17
• Young Mania Rating Scale under or equal to 17

You may not qualify if:

• 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

Sponsors & Collaborators

• Psychiatric Centre Rigshospitalet: lead
• University of Copenhagen: collaborator
• IT University of Copenhagen: collaborator
• The European Union, 7.th Frame program: collaborator

Study Sites (1)

Psychiatric Center Copenhagen, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (2)

• 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: 32046986 DERIVED

• 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: 23883891 DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Maria Faurholt-Jepsen, MD

  Department of psychiatry, Copenhagen, 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, Medical doctor and PhD student

Study Record Dates

• First Submitted: September 26, 2011
• First Posted: October 5, 2011
• Study Start: October 1, 2011
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: March 30, 2016

Record last verified: 2016-03

Locations

DK (1)