Clinical trial NCT02456545: Improving Early Recognition and Intervention in At-risk Stages of Bipolar Disorders
Official title: Improving Early Recognition and Intervention in At-risk Stages of Bipolar Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar Disorder
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
name: Charite University, Berlin, Germany
name: Ruhr University of Bochum
name: Goethe University
name: Universitätsklinikum Hamburg-Eppendorf
name: Philipps University Marburg
name: University Hospital Tuebingen
name: Vivantes Hospital am Urban, Berlin
First posted: 2015-05-28
Enrollment: 1419
Sex: ALL
Minimum age (years): 15
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Risk groups I: help-seeking persons with subthreshold symptoms

Risk group II: in- and outpatients with depressive disorder

Risk group III: in- and outpatients with ADHD

representative population cohort from IMAGEN study

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Prodromal Symptoms for bipolar development via BPSS-FP & EPIbipolar
timeFrame: baseline
measure: Prodromal Symptoms for bipolar development via BPSS-FP & EPIbipolar
timeFrame: 1-year follow-up
measure: Prodromal Symptoms for bipolar development via BPSS-FP & EPIbipolar
timeFrame: 2-year follow-up
measure: Diagnostic Status: psychiatric disorders via SCID-I
timeFrame: baseline
measure: Diagnostic Status: psychiatric disorders via SCID-I
timeFrame: 1-year follow-up
measure: Diagnostic Status: psychiatric disorders via SCID-I
timeFrame: 2-year follow-up
Secondary outcomes:
measure: Psychotic Prodrome via PQ-16 (SOPS, SPi-A)
timeFrame: baseline
measure: Personality disorder via SCID-II (screening)
timeFrame: baseline
measure: Depressive Symptoms via Montgomery-Åsberg Depression Rating Scale (MADRS)
timeFrame: baseline
measure: Depressive Symptoms via Quick Inventory of Depressive Symptomatology (QIDS-SR16)
timeFrame: baseline
measure: Manic Symptoms via Young Mania Rating Scale (YMRS)
timeFrame: baseline
measure: Manic Symptoms via Altman Self-Rating Mania Scale (ASRM)
timeFrame: baseline
measure: Functional Impairment via Functioning Assessment Short Test (FAST)
timeFrame: baseline
measure: Functional Impairment via Functioning Assessment Short Test (FAST)
timeFrame: 1-year follow-up
measure: Functional Impairment via Functioning Assessment Short Test (FAST)
timeFrame: 2-year follow-up
measure: Functioning via GAF-scale
timeFrame: baseline
measure: Functioning via GAF-scale
timeFrame: 1-year follow-up
measure: Functioning via GAF-scale
timeFrame: 2-year follow-up
measure: Impulsiveness via Barrat Impulsiveness Scale (BIS)
timeFrame: baseline
measure: Traumatic life events in childhood via Childhood Trauma Questionnaire (CTQ-SF)
timeFrame: baseline
measure: Affective temperament via Temperament Evaluation of Memphis, Pisa, Paris, and San Diego-Autoquestionnaire version (TEMPS-A)
timeFrame: baseline
measure: Creativity via Barron Welsh Art Scale (BWAS)
timeFrame: baseline
measure: Creative Achievement via Creative Achievement Questionnaire (CAQ)
timeFrame: baseline
measure: Chronic Stress via Trierer Inventar zum chronischen Stress (TICS)
timeFrame: baseline
measure: Ressources and self-management via Fragebogen zur Erfassung von Ressourcen und Selbstmanagementfähigkeit (FERUS)
timeFrame: baseline
measure: Quality of life via WHOQOL-BREF
timeFrame: baseline
measure: Quality of life via WHOQOL-BREF
timeFrame: 1-year follow-up
measure: Quality of life via WHOQOL-BREF
timeFrame: 2-year follow-up
measure: Sensitivity of Behavioral Inhibition System and Behavioral Activation System via BIS/BAS scales
timeFrame: baseline
measure: Life events and -changes via Life Events Questionnaire (LEQ)
timeFrame: baseline
measure: Life events and -changes via Life Events Questionnaire (LEQ)
timeFrame: 1-year follow-up
measure: Life events and -changes via Life Events Questionnaire (LEQ)
timeFrame: 2-year follow-up
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite University Berlin
city: Berlin
country: Germany
facility: Vivantes Hospital am Urban
city: Bochum
country: Germany
facility: Ruhr University of Bochum
city: Dresden
country: Germany
facility: University Hospital Dresden, Präventionsambulanz mit Früherkennungszentrum
city: Frankfurt a.M.
country: Germany
facility: University Hospital Frankfurt
city: Hamburg
country: Germany
facility: University Hospital Hamburg-Eppendorf
city: Marburg
country: Germany
facility: Philipps University of Marburg Medical Center
city: Neuruppin
country: Germany
facility: Ruppiner Kliniken, Klinik für Psychiatrie, Psychotherapie und Psychosomatik
city: Tuebingen
country: Germany
facility: University Hospital Tuebingen
Study officials:
affiliation: University Hospital Dresden, Technische Universität Dresden
name: Andrea Pfennig, Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Dresden, Technische Universität Dresden
name: Michael Bauer, Dr. rer. nat.
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Martin Lambert, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.