An observational study in Bipolar Disorder, sponsored by Technische Universität Dresden. Completed at 9 sites in Germany. Open to participants aged 15 Years to 35 Years. Per ClinicalTrials.gov, last updated 2024-08-07.
Sponsored by Technische Universität Dresden · Observational
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.
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:
1,637 studies on the registry are indexed under Bipolar Disorder; 258 are open to participants now.
This study's enrollment of 1,419 is above the median of 158 across 339 observational studies indexed under Bipolar Disorder.
Browse Bipolar Disorder studies →Technische Universität Dresden is the lead sponsor of 247 studies on the registry; 46 are open to participants now.
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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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Other: ≥ 1 potential risk factor for BD
in- and outpatients with depressive syndrome (SCID) anticipated n = 500
Other: depressive syndrome
in- and outpatients with Attention-Deficit/Hyperactivity-Disorder (ADHD) anticipated n = 150
Other: ADHD
representative population cohort from the IMAGEN study anticipated n = 500
exposure to ≥ 1 potential risk factors for BD (e.g. (sub)threshold affective symptomatology, anxiety, sleep disturbances, family history, episodic substance misuse)
in- and outpatients with depressive syndrome
in- and outpatients with ADHD
Prodromal Symptoms for bipolar development via BPSS-FP & EPIbipolar
* 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
Time frame: baseline
Prodromal Symptoms for bipolar development via BPSS-FP & EPIbipolar
* 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
Time frame: 1-year follow-up
Prodromal Symptoms for bipolar development via BPSS-FP & EPIbipolar
* 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
Time frame: 2-year follow-up
Diagnostic Status: psychiatric disorders via SCID-I
Diagnostic Status: psychiatric disorders via SCID-I
Time frame: baseline
Diagnostic Status: psychiatric disorders via SCID-I
Diagnostic Status: psychiatric disorders via SCID-I
Time frame: 1-year follow-up
Diagnostic Status: psychiatric disorders via SCID-I
Diagnostic Status: psychiatric disorders via SCID-I
Time frame: 2-year follow-up
Psychotic Prodrome via PQ-16 (SOPS, SPi-A)
Screening for psychotic prodrome using Prodromal Questionnaire - PQ-16 Assessing psychotic prodrome after positive screening via Structured Interview for Prodromal Syndroms - SOPS and Schizophrenia Proneness Instrument, Adult Version - SPi-A (german version)
Time frame: baseline
Personality disorder via SCID-II (screening)
self-report screening questionnaire for personality disorder via SCID-II Assessing personality disorder via SCID-II after positive screening
Time frame: baseline
Depressive Symptoms via Montgomery-Åsberg Depression Rating Scale (MADRS)
Clinician-rated severity of depressive symptoms over the past 7 days, 10 items, scoring 0-6 each, yielding a total between 0 and 60.
Time frame: baseline
Depressive Symptoms via Quick Inventory of Depressive Symptomatology (QIDS-SR16)
Self-rated severity of depressive symptoms over the past 7 days, 16 items, scoring 0-3 each, yielding a total between 0 and 48.
Time frame: baseline
Manic Symptoms via Young Mania Rating Scale (YMRS)
Clinician-rated severity of manic symptoms over the past 48 hours, 11 items, 7 items scoring 0-4 each,4 items scoring 0-8 each, yielding a total between 0 and 60.
Time frame: baseline
Manic Symptoms via Altman Self-Rating Mania Scale (ASRM)
Self-rated severity of manic symptoms over the past 7 days, 5 items, scoring 0-4 each (0=no difficulty, 3=severe difficulty), yielding a total between 0 and 50.
Time frame: baseline
Functional Impairment via Functioning Assessment Short Test (FAST)
Clinician-rated functional impairment over the past 48 hours, 24 items, scoring 0-3 each (0=no difficulty, 3=severe difficulty), yielding a total between 0 and 72.
Time frame: baseline
Functional Impairment via Functioning Assessment Short Test (FAST)
Clinician-rated functional impairment over the past 48 hours, 24 items, scoring 0-3 each (0=no difficulty, 3=severe difficulty), yielding a total between 0 and 72.
Time frame: 1-year follow-up
Functional Impairment via Functioning Assessment Short Test (FAST)
Clinician-rated functional impairment over the past 48 hours, 24 items, scoring 0-3 each (0=no difficulty, 3=severe difficulty), yielding a total between 0 and 72.
Time frame: 2-year follow-up
Functioning via GAF-scale
Clinician-rated global functioning at the present moment via Global Assessment of Functioning scale (GAF-scale), scoring between 1-100 (1=no difficulty, 100=Persistent danger of severely hurting self or others or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death)
Time frame: baseline
Functioning via GAF-scale
Clinician-rated global functioning at the present moment via Global Assessment of Functioning scale (GAF-scale), scoring between 1-100 (1=no difficulty, 100=Persistent danger of severely hurting self or others or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death)
Time frame: 1-year follow-up
Functioning via GAF-scale
Clinician-rated global functioning at the present moment via Global Assessment of Functioning scale (GAF-scale), scoring between 1-100 (1=no difficulty, 100=Persistent danger of severely hurting self or others or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death)
Time frame: 2-year follow-up
Impulsiveness via Barrat Impulsiveness Scale (BIS)
Self-rated measure of impulsiveness, 30 items, scoring 1-4 each (1=rarely/never, 4=almost always/always), yielding a total between 30 and 120.
Time frame: baseline
Traumatic life events in childhood via Childhood Trauma Questionnaire (CTQ-SF)
Retrospective self-report to identify adolescent and adult clients with histories of trauma, 28 items, scoring on a 5-point Likert-type scale according to the frequency with which experiences occurred ("never true" to "very often true").
Time frame: baseline
Affective temperament via Temperament Evaluation of Memphis, Pisa, Paris, and San Diego-Autoquestionnaire version (TEMPS-A)
Self-rated assessment of five affective temperaments, 30 items, dichotomous scale 0="applies", 1= "does not apply".
Time frame: baseline
Creativity via Barron Welsh Art Scale (BWAS)
Assessment of the aesthetic preference by scoring "like" or "dislike" for certain black-and-white figures (85 items).
Time frame: baseline
Creative Achievement via Creative Achievement Questionnaire (CAQ)
Self-report measure of creative achievements across 10 domains, 96 items.
Time frame: baseline
Chronic Stress via Trierer Inventar zum chronischen Stress (TICS)
Self-rated measure of chronic stress in the past 3 months, 57 items, scoring 0-4 each (1=never, 4=almost always), yielding a total between 0 and 228.
Time frame: baseline
Ressources and self-management via Fragebogen zur Erfassung von Ressourcen und Selbstmanagementfähigkeit (FERUS)
Self-rated measure of health related ressources and self-management ability in the past two to three weeks, 66 items, scoring 1-5 each (1=strongly disagree, 4=strongly agree), yielding a total between 66 and 330.
Time frame: baseline
Quality of life via WHOQOL-BREF
Self-rated measure to assess subjective quality of life in the past two weeks, 26 items, 5-point scale with varying verbal equivalents
Time frame: baseline
Quality of life via WHOQOL-BREF
Self-rated measure to assess subjective quality of life in the past two weeks, 26 items, 5-point scale with varying verbal equivalents
Time frame: 1-year follow-up
Quality of life via WHOQOL-BREF
Self-rated measure to assess subjective quality of life in the past two weeks, 26 items, 5-point scale with varying verbal equivalents
Time frame: 2-year follow-up
Sensitivity of Behavioral Inhibition System and Behavioral Activation System via BIS/BAS scales
Self-rated measure to assess Sensitivity of the Behavioral Inhibition System and the Behavioral Activation System, 24 items, scoring 1-4 each (1=strongly disagree, 4=strongly agree) yielding a total between 24 and 96.
Time frame: baseline
Life events and -changes via Life Events Questionnaire (LEQ)
Inventory to assess life events and -changes during the past year, 82 items, choosing applying life events from a list of 82 events, rating Type of effect (good vs bad) and effect of event on life (0=no effect, 3=great effect).
Time frame: baseline
Life events and -changes via Life Events Questionnaire (LEQ)
Inventory to assess life events and -changes during the past year, 82 items, choosing applying life events from a list of 82 events, rating Type of effect (good vs bad) and effect of event on life (0=no effect, 3=great effect).
Time frame: 1-year follow-up
Life events and -changes via Life Events Questionnaire (LEQ)
Inventory to assess life events and -changes during the past year, 82 items, choosing applying life events from a list of 82 events, rating Type of effect (good vs bad) and effect of event on life (0=no effect, 3=great effect).
Time frame: 2-year follow-up
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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