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Bipolar DisorderBipoLife-A1NCT02456545

Improving Early Recognition and Intervention in At-risk Stages of Bipolar Disorders

An observational study of Bipolar Disorder, run by Technische Universität Dresden at 9 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 15 to 35 years
Conditions the study is for
Bipolar Disorder
What is being tested?
≥ 1 potential risk factor for BD, depressive syndrome and ADHD
How many people
1,419 participants
Where
9 sitesGermany
Study dates
3 Jun 2015to 30 Oct 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 35 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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

Who may be able to join

  • 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

Who cannot join

  • bipolar disorder
  • schizaffective disorder
  • schizophrenia
  • dominating anxiety disorder, obsessive-compulsive disorder
  • dominating substance-related disorder

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Germany9 sites

  • Charite University Berlin

    Berlin, 10117

  • Vivantes Hospital am Urban

    Berlin, 10967

  • Ruhr University of Bochum

    Bochum, 44801

  • University Hospital Dresden, Präventionsambulanz mit Früherkennungszentrum

    Dresden, 01307

  • University Hospital Frankfurt

    Frankfurt a.M., 60596

  • University Hospital Hamburg-Eppendorf

    Hamburg, 20246

  • Philipps University of Marburg Medical Center

    Marburg, 35037

  • Ruppiner Kliniken, Klinik für Psychiatrie, Psychotherapie und Psychosomatik

    Neuruppin, 16816

  • University Hospital Tuebingen

    Tübingen, 72076

Other trials in Germany

About this study

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.

Read the 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.
Being tested
≥ 1 potential risk factor for BD, depressive syndrome, ADHD
Medical subject headings
Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ≥ 1 potential risk factor for BDOther

    exposure to ≥ 1 potential risk factors for BD (e.g. (sub)threshold affective symptomatology, anxiety, sleep disturbances, family history, episodic substance misuse)

  • depressive syndromeOther

    in- and outpatients with depressive syndrome

  • ADHDOther

    in- and outpatients with ADHD

Study groups in NCT02456545
Study groupRoleWhat they receive
help-seekers at-riskpersons 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
Receives: Other: ≥ 1 potential risk factor for BD
patients with depressive syndromein- and outpatients with depressive syndrome (SCID) anticipated n = 500
Receives: Other: depressive syndrome
patients with ADHDin- and outpatients with Attention-Deficit/Hyperactivity-Disorder (ADHD) anticipated n = 150
Receives: Other: ADHD
representative population cohortrepresentative population cohort from the IMAGEN study anticipated n = 500

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: baseline

  2. 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

    Measured: 1-year follow-up

  3. 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

    Measured: 2-year follow-up

  4. Diagnostic Status: psychiatric disorders via SCID-I

    Diagnostic Status: psychiatric disorders via SCID-I

    Measured: baseline

  5. Diagnostic Status: psychiatric disorders via SCID-I

    Diagnostic Status: psychiatric disorders via SCID-I

    Measured: 1-year follow-up

  6. Diagnostic Status: psychiatric disorders via SCID-I

    Diagnostic Status: psychiatric disorders via SCID-I

    Measured: 2-year follow-up

Secondary outcomes (26)

  1. 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)

    Measured: baseline

  2. 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

    Measured: baseline

  3. 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.

    Measured: baseline

  4. 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.

    Measured: baseline

  5. 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.

    Measured: baseline

  6. 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.

    Measured: baseline

  7. 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.

    Measured: baseline

  8. 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.

    Measured: 1-year follow-up

  9. 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.

    Measured: 2-year follow-up

  10. 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)

    Measured: baseline

  11. 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)

    Measured: 1-year follow-up

  12. 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)

    Measured: 2-year follow-up

  13. 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.

    Measured: baseline

  14. 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").

    Measured: baseline

  15. 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".

    Measured: baseline

  16. 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).

    Measured: baseline

  17. Creative Achievement via Creative Achievement Questionnaire (CAQ)

    Self-report measure of creative achievements across 10 domains, 96 items.

    Measured: baseline

  18. 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.

    Measured: baseline

  19. 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.

    Measured: baseline

  20. 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

    Measured: baseline

  21. 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

    Measured: 1-year follow-up

  22. 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

    Measured: 2-year follow-up

  23. 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.

    Measured: baseline

  24. 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).

    Measured: baseline

  25. 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).

    Measured: 1-year follow-up

  26. 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).

    Measured: 2-year follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2015 (estimated)
  2. Study start3 Jun 2015
  3. Primary completion30 Oct 2020
  4. Study completion30 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,419 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02456545
Sponsor's protocol ID
BipoLife-A1
Acronym
BipoLife-A1
Status last verified
Aug 2024
First submitted
11 May 2015
Last updated
7 Aug 2024
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 22239567

  • 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.

    PubMed 24807784

  • 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.

    PubMed 21802741

  • Thomas-Odenthal F, Stein F, Vogelbacher C, Alexander N, Bechdolf A, Bermpohl F, Brockel K, Brosch K, Correll CU, Evermann U, Falkenberg I, Fallgatter A, Flinkenflugel K, Grotegerd D, Hahn T, Hautzinger M, Jansen A, Juckel G, Krug A, Lambert M, Leicht G, Leopold K, Meinert S, Mikolas P, Mulert C, Nenadic I, Pfarr JK, Reif A, Ringwald K, Ritter P, Stamm T, Straube B, Teutenberg L, Thiel K, Usemann P, Winter A, Wroblewski A, Dannlowski U, Bauer M, Pfennig A, Kircher T. Larger putamen in individuals at risk and with manifest bipolar disorder. Psychol Med. 2024 Aug;54(11):3071-3081. doi: 10.1017/S0033291724001193. Epub 2024 May 27.

    PubMed 38801091

Questions about this trial

What is this clinical trial studying?

An observational study of Bipolar Disorder, run by Technische Universität Dresden at 9 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prodromal Symptoms for bipolar development via BPSS-FP & EPIbipolar (time frame: baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02456545, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.

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