BIPLONG - The Bipolar Disorder in the Longitudinal Course

NCT05064995 | Unknown

• 1 other identifier: 25-355 ex 12/13
• Study Type: observational
• Target: 560
• Locations: 1 country
• Sites: 1

Brief Summary

The BIPLONG (The Bipolar Disorder in the Longitudinal Course ) study is a longitudinal study on the course of bipolar disorders and comprises two sub-studies: On the one hand, BIPLONG examines the genetic foundation and change in bipolar disorder, on the other hand, metabolic changes, clinical symptoms and cognition in bipolar disorders is evaluated. A current subproject of BIPLONG is the analysis of the psychological response of the COVID-19 (Corona virus disease) pandemic. With the parameters examined in BIPLONG, it is hoped to gain better understanding of the bipolar disorder in the longitudinal course.

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (32)

• CVLT- california verbal learning test

  The California Verbal Learning Test (CVLT) provides a brief and individualized assessment of verbal learning strategies and processes. The higher the score, the better the outcome

  at six months

• STROOP Farbe-Wort-Interferenz-Test (FWIT)

  As an objective and reliable multidimensional performance test, the Color-Word. The Interference Test measures elementary information processing skills (selection, encoding, and decoding) in the visual-verbal functional domain. The lower the score, the better the outcome.

  at six months

• D2-R

  To measure the subject's ability to concentrate and the speed and accuracy in distinguishing similar visual stimuli. The higher the score, the better the outcome.

  at six months

• "Reading the eyes of the mind" =Theory of mind

  measurement of the ability to detect social cues. The higher the score, the better the outcome.

  at six months

• Trail Making Test A/B, TMT-A

  Measurement of cognitive processing speed, as well as linguistic, executive, and attentional components. The lower the score, the better the outcome.

  at six months

• Mehrfachwahl Wortschatz Test (MWT-B)

  Measurement of the general intelligence level. The higher the score, the better the outcome.

  at six months

• Number Symbol Test

  Measurement of processing speed. The higher the score, the better the outcome.

  at six months

• Number Repeat

  Measurement of working memory. The higher the score, the better the outcome.

  at six months

• Beck Depressions Inventar II (BDI-II)

  Measurement of depression severity; 21 items on a scale of 0-3 (ascending). The higher the score, the worse the outcome.

  at six months

• Manie-Selbstbeurteilungsskala (MSS) (self-rating scale)

  Measurement of manic symptoms; 48 items (dichotomous). The higher the score, the worse the outcome.

  at six months

• Questionnaire of religiosity

  socio-demographic assesment of religiosity; 2 items.

  at six months

• Big Five Inventory-10 (BFI-10)

  Measurement of personality variables; 10 items on a scale of 1-5 (ascending).

  at six months

• World Health Organisation Quality of Life (WHOQOL Bref)

  Measurement of life-quality and health; 26 items on a scale of 1-5 (ascending).

  at six months

• Life Event Questionnaire (LEQ)

  Measurement of life events and their influence; 79 items on a scale of 0-3 (ascending)

  at six months

• Temperament and affective disorders (TEMPS-A)-Scale

  35 items on a scale of 1-5 (ascending). The higher the score, the better the outcome.

  at six months

• Brief symptom inventory (BSI)

  Measurement of psychological symptoms; 53 items on a scale of 0-4 (ascending). The higher the score, the worse the outcome.

  at six months

• Anhedonia scale (AS)

  Measurement of Anhedonia; 14 items on a scale of 1-4 (ascending). The higher the score, the worse the outcome.

  at six months

• Maslach Burnout Inventory (MBI-GS-D)

  Measurement of burnout symptoms; 16 items on a scale of 1-6 (ascending). The higher the score, the worse the outcome.

  at six months

• Resources in Sexuality and Partnership (RSP)

  Measurement of relationship emotions; 25 items on a scale of 1-5 (ascending).The higher the score, the better the outcome.

  at six months

• Satisfaction in the couple relationship (ZIP)

  Measurement of relationship satisfaction; 7 items on a scale of 1-5 (ascending), 3 items open questioned. The higher the score, the better the outcome.

  at six months

• Demographic Data

  Measurement of demographic data

  at six months

• Questionnaire of current life situation

  Measurement of demographic and diagnostic data;

  at six months

• Anthropometric Data - weight

  Measurement of weight

  at six months

• Anthropometric Data- height

  Measurement of height

  at six months

• Anthropometric Data - waist-to-hip ratio

  Measurement of waist-to-hip ratio

  at six months

• Anthropometric Data - blood pressure

  Measurement of blood pressure

  at six months

• Clinical Global Impression (CGI)

  External rating of a symptom severity; 2 items on a scale of 0-7 (ascending). The higher the score, the better the outcome.

  at six months

• Global Assessment Scale of Functioning (GAF)

  External rating of level of functioning; 1 item on a scale of 1-100 (ascending). The higher the score, the better the outcome.

  at six months

• Hamilton Depression Scale (HAMD)

  External rating of depression symptoms; 21 items on a scale of 0-4 (ascending).The higher the score, the worse the outcome.

  at six months

• Young Mania Rating Scale (YMRS)

  External rating of manic symptoms; 11 items on a scale of 0-4/0-8 (ascending). The higher the score, the worse the outcome.

  at six months

• Specific Level of Functioning Assessment and Physical health Inventory (SLOF)

  External rating of functioning; 43 items on a scale of 1-5 (ascending), 2 items open questioned. The higher the score, the better the outcome.

  at six months

• Supplementary Data for External Rating

  External rating of bipolar symptoms; 7 items.

  at six months

Study Arms (2)

Patients

Patients with the Diagnosis of a Bipolar Disorder

Healthy Controls

Individuals with no diagnosis of Bipolar Disorder

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with bipolar disorder and healthy controls within the age frame of 18-75 are included.

You may qualify if:

• Pat. with bipolar disorder, with an age between 18 and 85 years.
• Euthymic/ maximum mildly depressed at the time of consent (for this, the severity of depression will be determined using the Hamilton Depression Scale, this will also be included in any calculations).

You may not qualify if:

• Pat. refuses participation
• Currently severely depressed/manic episode at the time of consent
• Other currently active severe mental/ brain organic disease (epilepsy, brain tumor..)
• St.p. severe craniocerebral trauma/ brain surgery.
• Reduced intelligence (IQ\< 70)
• Moderate/ severe dementia (Mini Mental Status Examination, MMSE, 20 and above)
• Clearly substance-induced clinical picture
• For the whole procedure, made controls (age, gender) are needed. For this purpose we recruit controls by word of mouth or ask relatives of bipolar patients if they would like to participate. Patients are tested for the presence of a possible mental illness using Mini-DIPS (Diagnostisches Interview bei psychischen Störungen)
• First-degree relatives with severe mental illness.
• Severe active drug dependence (i.e. alcohol, benzodiazepines morphines)
• Current major depressive/ manic episode
• Other currently active severe mental/ brain illness (epilepsy, brain tumor..)
• St.p. severe craniocerebral trauma/ brain surgery.
• Congenital/ early childhood acquired intelligence impairment
• Moderate/ severe dementia (from MMSE 20)

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University Graz

Graz, Styria, 8036, Austria

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Central Study Contacts

Eva Reininghaus, MD, PhD, MBA

CONTACT

+43 316 385 80968; eva.reininghaus@medunigraz.at

Nina Dalkner, PhD, MSc

CONTACT

+43 316 385 30081; nina.dalkner@medunigraz.at

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: October 1, 2021
• Study Start: June 13, 2013
• Primary Completion: June 13, 2022
• Study Completion: June 13, 2022
• Last Updated: October 1, 2021

Record last verified: 2021-09

Locations

AU (1)