AKTIBIPO400 clinical study

The aim of the AKTIBIPO400 research study is to find biomarkers of upcoming relapse in bipolar disorder BD)

The findings of the study will be applied into a telemetry system for monitoring clinical state of BD patients. Our motivation is to reduce the risk of recurrent relapses and hospitalizations.

The study is organized by MINDPAX GmbH in cooperation with the National Institute of Mental Health, Klecany, Czech Republic.

Participant enrollment is now ended.



Informace v Češtině





Study description

 Annotation

Up to 400 patients with the bipolar affective disorder diagnosis (according to ICD-10) and 40 healthy controls, are followed for 18 months. A continuous, 24-hour telemetric monitoring of the actigraphic record is performed during the study period. Subjective and objective data about mood changes of the examined person are continuously monitored and affective relapse is determined based on the previous definition.

Key information

Study name (EN): AKTIBIPO400 study - Relapse prediction in Bipolar Disorder using telemetry monitoring of circadian rhythmicity.

Study name (CZ): Studie AKTIBIPO400 – Predikce relapsu bipolární afektivní poruchy pomocí telemetrického sledování sociální rytmicity.

Study type: Observational, non-interventional, non-pharmacological prospective case-control study

Study aims: Prospective monitoring of physical activity of bipolar disorder (BD) patients and healthy controls (HC) using wrist-worn actigraphy system with telemetric data transmission, self-assessment questionnaires and clinical scales. The aim is to investigate the connection between physical activity and clinical state of BD patients and healthy controls.

Study duration: 18 months for BD patients, 3 months for HC with possible extension through a follow-up study

Cohort size: Up to 400 BD patients and 40 HC

Study population: Men and women age 18-60 with ICD-10 diagnosis of bipolar disorder (F31.x) and healthy controls of the same age range.

Institutions: AKTIBIPO400 study is carried out by Mindpax GmbH (www.mindpax.me) in cooperation with the National institute of mental health in Klecany, Czech Republic (www.nudz.cz/en)

Primary investigator: MUDr Filip Španiel, Ph.D.m National Institute of Mental Health, filip.spaniel@nudz.cz

Ethical committee: the study has been approved by the ethical committee of the National Institute of Mental Health, Klecany, Czech Republic, under the filing. no. 101/17

Methods

Study population

In total, 400 patients with the diagnosis of bipolar affective disorder and 40 healthy controls are enrolled in the study after signing the Informed consent. The study population is divided into 3 groups – Core, Periphery 1, Periphery 2.

Core Group

Patients who passed entrance pre-screening questionnaire [BIPO-Q] and come to the initial visit to National Mental Health Institute in Prague to be assessed by the physician. The outcome of the visit is their Bipolarity Index which must be 50% or more to assess patient to the Core group. In an active study phase, they fill weekly questionnaire, so called Actibipo Self -Rating questionnaire (ASERT) and are monthly scaled by research psychologist with MADRS and YMRS scales. Their psychiatrist cooperates during the study by providing information about patients state every 6 months (mood changes, medication, hospitalization).

Periphery 1

Patients who passed entrance pre-screening questionnaire BIPO-Q and are not able or willing to come to entrance visit to National Mental Health Institute. In an active study phase, they fill weekly questionnaire ASERT. Their psychiatrist cooperates during the study by providing information about patients state every 6 months (mood changes, medication, hospitalization).

Periphery 2

Either a) patients who passed entrance pre-screening questionnaire BIPO-Q and are not able or willing to come to entrance visit to NIMH. In an active study phase, they fill weekly questionnaire ASERT. Their psychiatrist does not cooperate during the study by providing information about patients state every 6 months (mood changes, medication, hospitalization) or b) patients who did not pass the entrance pre-screening questionnaire BIPO-Q and/or are not able or willing to come to the entrance visit to NIMH. In an active study phase, they fill weekly questionnaire ASERT. Their psychiatrist cooperates during the study by providing information about patients state every 6 months (mood changes, medication, hospitalization).

Healthy controls

Upon filling a contact form, the healthy controls were screened using the MINI questionnaire by a study psychologist. Controls, who passed the screening, were enrolled into the study and obtained the actigraphy device and mobile application. 

Inclusion and exclusion criteria 

For Patients, the inclusion criteria were

  1. Diagnosis of Bipolar Affective disorder according to ICD-10               
  2. History of two or more affective episodes.
  3. Remission at baseline, defined as:
    1.  [YMRS] total score ≤ 12 and
    2.  [MADRS] total score ≤ 9

 

The exclusion criteria for patients were the presence of an organic mental disease, mental retardation (IQ<80), dependence on psychoactive substances and/or alcohol.

 

For healthy controls the exclusion criteria were: Any existing psychiatric diagnosis, family history of psychiatric disorder among 1st-order relatives, severe brain disease, mental retardation (IQ<80).

Monitored variables

Subjective quantification of patient's mood

In course of the study, the enrolled patients monitor subjectively perceived presence of signs of mania/depression using a 10-point questionnaire (ASERT) filled-out using a mobile application. The output is integrated with the actigraphic record.

Objective assessment of the patient's health condition

Starting from the beginning of the study, one telephone call is performed for every month (in total, calls: 1-18), where an examination by an experienced psychologist is performed. The patient is scored using the Young Mania Rating Scale [YMRS] and Montgomery-Åsberg Depression Rating Scale [MADRS]

Qualitative Data

On top of weekly collected Subjective quantification of patient's mood (ASERT questionnaire) and monthly collected Objective assessment of the patient's health condition (MADRS, YMRS), data about hospitalisations, medication changes and divers of patient events are collected.

Actigraphy

The activity is captured using a Mindpax activity monitor, worn continuously on the wrist of the non-dominant arm. The subjects are instructed to wear the tracker at all times and to remove it only when necessary (the tracker is water, dust and shock-proof). The actigraphy data is regularly transferred to a cloud system via a mobile application (Mindpax M0) in participant’s smartphone. 

Relapse definition

Relapse index of the disease is characterized by the following criteria :

We are grateful to all study participants for their willingness to participate and provide valuable data for advancement of BD research.