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

NCT02456545 | Completed DMC

• 1 other identifier: BipoLife-A1
• Study Type: observational
• Target: 1,419
• Locations: 1 country
• Sites: 9

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.

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (6)

• 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

  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

  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

  2-year follow-up

• Diagnostic Status: psychiatric disorders via SCID-I

  Diagnostic Status: psychiatric disorders via SCID-I

  baseline

• Diagnostic Status: psychiatric disorders via SCID-I

  Diagnostic Status: psychiatric disorders via SCID-I

  1-year follow-up

• Diagnostic Status: psychiatric disorders via SCID-I

  Diagnostic Status: psychiatric disorders via SCID-I

  2-year follow-up

Secondary Outcomes (26)

• Psychotic Prodrome via PQ-16 (SOPS, SPi-A)

  baseline

• Personality disorder via SCID-II (screening)

  baseline

• Depressive Symptoms via Montgomery-Åsberg Depression Rating Scale (MADRS)

  baseline

• Depressive Symptoms via Quick Inventory of Depressive Symptomatology (QIDS-SR16)

  baseline

• Manic Symptoms via Young Mania Rating Scale (YMRS)

  baseline

Study Arms (4)

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

Other: ≥ 1 potential risk factor for BD

patients with depressive syndrome

in- and outpatients with depressive syndrome (SCID) anticipated n = 500

Other: depressive syndrome

patients with ADHD

in- and outpatients with Attention-Deficit/Hyperactivity-Disorder (ADHD) anticipated n = 150

Other: ADHD

representative population cohort

representative population cohort from the IMAGEN study anticipated n = 500

Interventions

≥ 1 potential risk factor for BD OTHER

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

help-seekers at-risk

depressive syndrome OTHER

in- and outpatients with depressive syndrome

patients with depressive syndrome

ADHD OTHER

in- and outpatients with ADHD

patients with ADHD

Eligibility Criteria

• Age: 15 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Technische Universität Dresden: lead
• German Federal Ministry of Education and Research: collaborator
• Charite University, Berlin, Germany: collaborator
• Ruhr University of Bochum: collaborator
• Goethe University: collaborator
• Universitätsklinikum Hamburg-Eppendorf: collaborator
• Philipps University Marburg: collaborator
• University Hospital Tuebingen: collaborator
• Vivantes Hospital am Urban, Berlin: collaborator

Study Sites (9)

Charite University Berlin

Berlin, 10117, Germany

Location

Vivantes Hospital am Urban

Berlin, 10967, Germany

Location

Ruhr University of Bochum

Bochum, 44801, Germany

Location

University Hospital Dresden, Präventionsambulanz mit Früherkennungszentrum

Dresden, 01307, Germany

Location

University Hospital Frankfurt

Frankfurt a.M., 60596, Germany

Location

University Hospital Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Philipps University of Marburg Medical Center

Marburg, 35037, Germany

Location

Ruppiner Kliniken, Klinik für Psychiatrie, Psychotherapie und Psychosomatik

Neuruppin, 16816, Germany

Location

University Hospital Tuebingen

Tübingen, 72076, Germany

Location

Related Publications (3)

• 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.

  PMID: 22239567 BACKGROUND

• 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.

  PMID: 24807784 BACKGROUND

• 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.

  PMID: 21802741 BACKGROUND

Related Links

• further patient information
• Project providing participants from representational cohort

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Andrea Pfennig, Dr. med.

  University Hospital Dresden, Technische Universität Dresden

  PRINCIPAL INVESTIGATOR

• Michael Bauer, Dr. rer. nat.

  University Hospital Dresden, Technische Universität Dresden

  PRINCIPAL INVESTIGATOR

• Martin Lambert, Dr. med.

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. Andrea Pfennig

Study Record Dates

• First Submitted: May 11, 2015
• First Posted: May 28, 2015
• Study Start: June 3, 2015
• Primary Completion: October 30, 2020
• Study Completion: October 30, 2020
• Last Updated: August 7, 2024

Record last verified: 2024-08

Locations

DE (9)