Improving Early Recognition and Intervention in At-risk Stages of Bipolar Disorders
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bipolar Disorder
- Sponsor
- Technische Universität Dresden
- Enrollment
- 1419
- Locations
- 9
- Primary Endpoint
- Diagnostic Status: psychiatric disorders via SCID-I
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Andrea Pfennig
Prof. Dr. med. Andrea Pfennig
Technische Universität Dresden
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
Outcomes
Primary Outcomes
Diagnostic Status: psychiatric disorders via SCID-I
Time Frame: 2-year follow-up
Diagnostic Status: psychiatric disorders via SCID-I
Prodromal Symptoms for bipolar development via BPSS-FP & EPIbipolar
Time Frame: 2-year follow-up
* Bipolar Prodrome Symptom Scale - Full Prospective - BPSS-FP describes and rates prodromal mania/depression and other symptoms that have occurred in the past month and in the past year; * Early Phase Inventory for bipolar disorders - EPIbipolar describes and rates symptoms associated with BD in the early phase (past 12 months) as sleep and circadian rhythm, mood swings and neuroticism, anxiety, functioning and comorbidity in childhood and youth, substance use, development of symptomatic pattern
Secondary Outcomes
- Personality disorder via SCID-II (screening)(baseline)
- Depressive Symptoms via Quick Inventory of Depressive Symptomatology (QIDS-SR16)(baseline)
- Manic Symptoms via Altman Self-Rating Mania Scale (ASRM)(baseline)
- Functioning via GAF-scale(2-year follow-up)
- Functional Impairment via Functioning Assessment Short Test (FAST)(2-year follow-up)
- Quality of life via WHOQOL-BREF(2-year follow-up)
- Sensitivity of Behavioral Inhibition System and Behavioral Activation System via BIS/BAS scales(baseline)
- Manic Symptoms via Young Mania Rating Scale (YMRS)(baseline)
- Affective temperament via Temperament Evaluation of Memphis, Pisa, Paris, and San Diego-Autoquestionnaire version (TEMPS-A)(baseline)
- Creativity via Barron Welsh Art Scale (BWAS)(baseline)
- Psychotic Prodrome via PQ-16 (SOPS, SPi-A)(baseline)
- Depressive Symptoms via Montgomery-Åsberg Depression Rating Scale (MADRS)(baseline)
- Traumatic life events in childhood via Childhood Trauma Questionnaire (CTQ-SF)(baseline)
- Creative Achievement via Creative Achievement Questionnaire (CAQ)(baseline)
- Chronic Stress via Trierer Inventar zum chronischen Stress (TICS)(baseline)
- Life events and -changes via Life Events Questionnaire (LEQ)(2-year follow-up)
- Impulsiveness via Barrat Impulsiveness Scale (BIS)(baseline)
- Ressources and self-management via Fragebogen zur Erfassung von Ressourcen und Selbstmanagementfähigkeit (FERUS)(baseline)