NCT02456545

Improving Early Recognition and Intervention in At-risk Stages of Bipolar Disorders

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,419 (actual)
• Sponsor: Technische Universität Dresden · Academic / Other
• Sex: All
• Age: 15 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Bipolar Disorder

Interventions

Type	Name	Description
OTHER	≥ 1 potential risk factor for BD	exposure to ≥ 1 potential risk factors for BD (e.g. (sub)threshold affective symptomatology, anxiety, sleep disturbances, family history, episodic substance misuse)
OTHER	depressive syndrome	in- and outpatients with depressive syndrome
OTHER	ADHD	in- and outpatients with ADHD

Timeline

• Start date: 2015-06-03
• Primary completion: 2020-10-30
• Completion: 2020-10-30
• First posted: 2015-05-28
• Last updated: 2024-08-07

Locations

9 sites across 1 country: Germany