Improving Early Recognition and Intervention in At-risk Stages of Bipolar Disorders (BipoLife-A1)

Technische Universität Dresden

Status: Completed

Conditions: Bipolar Disorder

Treatments: Other: ≥ 1 potential risk factor for BD; Other: depressive syndrome; Other: ADHD

Study type: Observational

Funder types: Other

Identifiers

NCT02456545

BipoLife-A1

Details and patient eligibility

About

Prospective multicentre observational study for treatment approaches in at-risk individuals. Furthermore the purpose of this study is to test feasibility of a clinical staging model and validate diagnostic tools to identify individuals at risk state for the development of BD.

Full description

This project is one out of nine projects and four translational platforms forming the core of an interdisciplinary consortium to research on the most important areas of uncertainties and unmet needs in early recognition and diagnostic assessment, prevention of relapse, and therapeutic strategies of BD.

Within this project, currently used diagnostic tools for subthreshold bipolar symptoms (BPSS-P, EPIbipolar, BAR criteria) will be deployed within the first 24 months in defined risk groups. Predictive power of individual risk factors/risk constellations will be determined regarding the manifestation and prodromal development of BD within ≥24 months (follow-up every 6 months). Potential resilience factors are ascertained. Additionally, the diagnostic tools will be used in a representative cohort (IMAGEN, to ascertain the prevalence of clinical/neurobiological at-risk constellations in non-selected youth and young adults, data from previous follow-ups will be used, suffering/help-seeking behavior will be assessed). Regarding treatment, at-risk subjects identified will be staged according to a pilot staging model. Treatment guidance is provided linked to the model, however, the naturalistic setting allows for individual decision making. Reasons for decisions will be ascertained, efficacy will be assessed with respect to symptomatology, psychosocial functioning and conversion to full BD, tolerability/safety will be assessed according to research standard. Outcomes will be assessed within ≥ 24 months. Using the results, the clinical staging model & guidance will be refined. The long-term goal is to provide a model for research and clinical initiatives.

Synopsis of study goals:

1. Determination of the predictive power of individual risk factors and risk constellations in defined risk groups for BD,
2. Identification of resilience factors,
3. Integration of results for further development of diagnostic tools and harmonization of the diagnostic process across centers,
4. Investigation of the process of treatment decision making, efficacy (acute/preventive effects) and tolerability/safety in at-risk subjects in a naturalistic setting, testing the feasibility of a pilot clinical staging model with treatment guidance,
5. Refinement of the staging model and guidance.

Enrollment: 1,419 patients

Sex: All

Ages: 15 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Risk group I: help-seeking persons consulting collaborating Early Recognition Centers presenting hints for ≥ 1 potential risk factor for BD (e.g. (sub)threshold affective symptomatology, anxiety, sleep disturbances, family history of bipolar disorder, episodic substance misuse, depressive syndrome)
• Risk group II: in- and outpatients with depressive syndrome (SCID) from the network sites
• Risk group III: in- and outpatients with ADHD already cared for in the Dept. of Child and Adolescent as well as Adult psychiatry in Würzburg
• Representative population cohort: IMAGEN study participants

Exclusion criteria

• bipolar disorder
• schizaffective disorder
• schizophrenia
• dominating anxiety disorder, obsessive-compulsive disorder
• dominating substance-related disorder

Trial design

1,419 participants in 4 patient groups

help-seekers at-risk

Description:

persons consulting collaborating Early Recognition Centers presenting with hints for ≥ 1 potential risk factor for BD (e.g. (sub)threshold affective symptomatology, anxiety, sleep disturbances, family history, episodic substance misuse, ADHD) anticipated n = 500

Treatment:

Other: ≥ 1 potential risk factor for BD

patients with depressive syndrome

Description:

in- and outpatients with depressive syndrome (SCID) anticipated n = 500

Treatment:

Other: depressive syndrome

patients with ADHD

Description:

in- and outpatients with Attention-Deficit/Hyperactivity-Disorder (ADHD) anticipated n = 150

Treatment:

Other: ADHD

representative population cohort

Description:

representative population cohort from the IMAGEN study anticipated n = 500