Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
1650

Summary

Conditions
Bipolar Disorder
Type
Observational
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Between 15 years and 35 years
Gender
Both males and females

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 ...

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: Determination of the predictive power of individual risk factors and risk constellations in defined risk groups for BD, Identification of resilience factors, Integration of results for further development of diagnostic tools and harmonization of the diagnostic process across centers, 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, Refinement of the staging model and guidance.

Tracking Information

NCT #
NCT02456545
Collaborators
  • German Federal Ministry of Education and Research
  • Charite University, Berlin, Germany
  • Ruhr University of Bochum
  • University Hospital, Frankfurt
  • Universitätsklinikum Hamburg-Eppendorf
  • Philipps University Marburg Medical Center
  • University Hospital Tuebingen
  • Vivantes Hospital am Urban, Berlin
Investigators
Principal Investigator: Andrea Pfennig, Dr. med. University Hospital Dresden, Technische Universität Dresden Principal Investigator: Michael Bauer, Dr. rer. nat. University Hospital Dresden, Technische Universität Dresden Principal Investigator: Martin Lambert, Dr. med. Universitätsklinikum Hamburg-Eppendorf