Smartphone-based Ambulatory Assessment of Early Warning Signs

Bipolar Disorder Clinical Trial

— BipoLife_A3  

Official title:

Smartphone-based Ambulatory Assessment of Early Warning Signs, Including Personalized Real-time Data-driven Therapeutic Interventions, in the Long-term Treatment of Bipolar Disorders.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02782910
• Other study ID #: BipoLife_A3
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: July 2020

Study information

• Verified date: May 2018
• Source: Technische Universität Dresden
• Contact: Emanuel Severus, MD
• Phone: +49 351 458 15489
• Email: emanuel.severus[@]uniklinikum-dresden.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Bipolar disorders are severe chronic disorders, marked by recurrent episodes of depression and (hypo)mania. The disorder usually emerges in early adulthood and tends to have a highly unpredictable course. Prevention of these episodes is essential, as they are associated with marked impairment in social and occupational functioning. The investigators propose to conduct a randomized, multi-center, observer-blind, parallel group controlled trial with an 78 week (18 month) intervention phase to test the hypothesis that continuous ambulatory real-time monitoring of early warning signs for new depressive or (hypo)manic episodes by smartphone based, innovative technology (e.g. GPS, acceleration sensor), including individual threshold- based early intervention for these early warning signs, will prolong time to a new mood episode and reduce hospitalizations (intervention group). In the control group ambulatory monitoring of early warning signs for emerging depressive or (hypo)manic episodes will occur in an identical manner, but the results will not be transmitted to the treating psychiatrist. All patients in this trial, irrespective of their group assignment, will receive guideline-based, state-of-the-art maintenance treatment.

Description:

Symptomatic outpatients with bipolar disorders I/II , will be consecutively assessed for eligibility. After having signed informed consent patients will receive open, guideline-based, state-of-the-art treatment for their current symptomatology ((hypo)manic and/or depressed) for up to 16 weeks. As soon as patients meet stabilisation criteria (YMRS total score < 12 and IDS total score < 12) they will be equipped with a study smartphone, for exclusive use during the study period, to assess the parameters of interest (activity, communication pattern, sleep pattern) and define the individual symptoms' threshold during 4 consecutive weeks of stabilisation . If patients fulfil randomization criteria (4 consecutive weeks with YMRS total score < 12 and IDStotal score < 12), they will enter the observer (rater) - blind, intervention phase, which will continue for 18 months (78 weeks). At randomization patients will be assigned to either the Smartphone-Based Ambulatory Assessment group, including real-time data capture and data-driven, individual symptoms' threshold-defined therapeutic interventions (SBAA+), in addition to state-of-the-art maintenance treatment or the Smartphone-Based Ambulatory Assessment group, only including real-time data capture (SBAA), in addition to state-of-the-art maintenance treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: July 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Bipolar Disorders (I/II)

• > 3 affective episodes in 5 years prior to index episode, with one of them being a (hypo)manic episode

• Age > 18 years

• Male or female

• Inpatients or outpatients

• Smartphone usage

• Each patient must have a level of understanding sufficient to agree to all tasks required by the protocol.

• Patients must be considered reliable.

• Each patient must sign an informed consent document prior to enrollment.

Exclusion Criteria:

• Current substance use disorder (except for tobacco and caffeine), moderate or severe, at enrolment

• Borderline personality disorder, antisocial personality disorder

• Dementia, organic brain disorders

• Unstable/inadequately treated medical illness

• Clinically significant cardiac, renal, hepatic, neoplastic or cerebrovascular disease

• Any medical condition posing a significant risk regarding adherence to study protocol

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Device:
• Smartphone-Based Ambulatory Assessment, Feedback via physician
Participants in the experimental condition SBAA+ will be contacted by their treating physician, once the predefined threshold for Smartphone activity is exceeded.

Locations

Country	Name	City	State
Germany	Department of Psychiatry and Psychotherapy	Dresden	Saxony

Sponsors (3)

Lead Sponsor	Collaborator
Technische Universität Dresden	German Federal Ministry of Education and Research, KIT (Karlsruher Institut für Technologie)

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to relapse	Time until new affective episode (hypomanic, manic, mixed, depressed) according to DSM V criteria	Duration of trial after randomisation (total of 18 months)
Secondary	Total time in episode	Percentage of assessments during intervention phase at which the criteria for an affective episode are met	Duration of trial after randomisation (total of 18 months)
Secondary	Severity of manic symptomatology	Average severity of manic symptoms at assessments during intervention phase, as judged by YMRS score	Duration of trial after randomisation (total of 18 months)
Secondary	Severity of depressive symptomatology	Average severity of depressive symptoms at assessments during intervention phase, as judged by IDS score.	Duration of trial after randomisation (total of 18 months)
Secondary	Total hospitalisation	Percentage of assessments during intervention phase at which the patient was hospitalized for an affective episode	Duration of trial after randomisation (total of 18 months)

External Links

•   Central study website