Improving Early Recognition and Intervention in At-risk Stages of Bipolar Disorders
NCT ID: NCT02456545
Last Updated: 2024-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1419 participants
OBSERVATIONAL
2015-06-03
2020-10-30
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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help-seekers at-risk
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
≥ 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)
patients with depressive syndrome
in- and outpatients with depressive syndrome (SCID)
anticipated n = 500
depressive syndrome
in- and outpatients with depressive syndrome
patients with ADHD
in- and outpatients with Attention-Deficit/Hyperactivity-Disorder (ADHD)
anticipated n = 150
ADHD
in- and outpatients with ADHD
representative population cohort
representative population cohort from the IMAGEN study
anticipated n = 500
No interventions assigned to this group
Interventions
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≥ 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)
depressive syndrome
in- and outpatients with depressive syndrome
ADHD
in- and outpatients with ADHD
Eligibility Criteria
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Inclusion Criteria
* 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
* schizaffective disorder
* schizophrenia
* dominating anxiety disorder, obsessive-compulsive disorder
* dominating substance-related disorder
15 Years
35 Years
ALL
No
Sponsors
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German Federal Ministry of Education and Research
OTHER_GOV
Charite University, Berlin, Germany
OTHER
Ruhr University of Bochum
OTHER
Goethe University
OTHER
Universitätsklinikum Hamburg-Eppendorf
OTHER
Philipps University Marburg
OTHER
University Hospital Tuebingen
OTHER
Vivantes Hospital am Urban, Berlin
UNKNOWN
Technische Universität Dresden
OTHER
Responsible Party
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Andrea Pfennig
Prof. Dr. med. Andrea Pfennig
Principal Investigators
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Andrea Pfennig, Dr. med.
Role: PRINCIPAL_INVESTIGATOR
University Hospital Dresden, Technische Universität Dresden
Michael Bauer, Dr. rer. nat.
Role: PRINCIPAL_INVESTIGATOR
University Hospital Dresden, Technische Universität Dresden
Martin Lambert, Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Hamburg-Eppendorf
Locations
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Charite University Berlin
Berlin, , Germany
Vivantes Hospital am Urban
Berlin, , Germany
Ruhr University of Bochum
Bochum, , Germany
University Hospital Dresden, Präventionsambulanz mit Früherkennungszentrum
Dresden, , Germany
University Hospital Frankfurt
Frankfurt a.M., , Germany
University Hospital Hamburg-Eppendorf
Hamburg, , Germany
Philipps University of Marburg Medical Center
Marburg, , Germany
Ruppiner Kliniken, Klinik für Psychiatrie, Psychotherapie und Psychosomatik
Neuruppin, , Germany
University Hospital Tuebingen
Tübingen, , Germany
Countries
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References
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Bechdolf A, Ratheesh A, Wood SJ, Tecic T, Conus P, Nelson B, Cotton SM, Chanen AM, Amminger GP, Ruhrmann S, Schultze-Lutter F, Klosterkotter J, Fusar Poli P, Yung AR, Berk M, McGorry PD. Rationale and first results of developing at-risk (prodromal) criteria for bipolar disorder. Curr Pharm Des. 2012;18(4):358-75. doi: 10.2174/138161212799316226.
Correll CU, Olvet DM, Auther AM, Hauser M, Kishimoto T, Carrion RE, Snyder S, Cornblatt BA. The Bipolar Prodrome Symptom Interview and Scale-Prospective (BPSS-P): description and validation in a psychiatric sample and healthy controls. Bipolar Disord. 2014 Aug;16(5):505-22. doi: 10.1111/bdi.12209. Epub 2014 May 8.
Leopold K, Ritter P, Correll CU, Marx C, Ozgurdal S, Juckel G, Bauer M, Pfennig A. Risk constellations prior to the development of bipolar disorders: rationale of a new risk assessment tool. J Affect Disord. 2012 Feb;136(3):1000-10. doi: 10.1016/j.jad.2011.06.043. Epub 2011 Jul 30.
Related Links
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further patient information
Project providing participants from representational cohort
Other Identifiers
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BipoLife-A1
Identifier Type: -
Identifier Source: org_study_id
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