BIPLONG - The Bipolar Disorder in the Longitudinal Course
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
Study Procedure:
In addition to the bipolar patients, healthy controls will also be included. The same inventories will be used for the control subjects and the same examinations or visits will be performed; bipolar-specific disease questions will not be asked in controls.
Intervention: Longitudinal study
Method:
All patients and controls undergo several assessments every six months:
Blood samples are collected with the following main parameters of interest being examined:
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Collection and analysis of DNA, establishment of permanent cell lines, determination of mRNA and gene products (proteins), proteomics, lipidomics.
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Routine parameters: Blood count, TSH, T3, T4, homocysteine, creatinine, amylase, lipase, CK, urea, uric acid, coagulation, HBA1c, glucose, lipids (triglyceryl, LDL, HDL, cholesterol, mass spectrometry), transaminases, CRP- levels, vitamin D.
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Biomarkers: oxidative stress parameters and antioxidants, neuroinflammatory markers (e.g. interleukins, tumor necrosis factor, interferons, GDNF, VEGF, etc.), neurotrophins (BDNF, NT, Trk..), insulin, IGF, adipokines, Apo-E and AAT analysis, tryptophan/kynurenine metabolites
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Intestinal hormones grehlin, glucagon-like peptides 1 and 2 (GLP-1/2) and cholecystokinin
Additionally, socio-demographic data and psychological data are collected by administering self-assessment questionnaires. Further, neurocognitive tests are administered.
The current psychological and psychiatric state of all subjects is examined by external ratings done by experts.
Anthropomethric measures are examined (waist-to-hip ratio, blood pressure, weight, height).
Additionally, MRI is conducted on all subjects (for patients every 6 months, for controls every 12 months).
Primary hypothesis:
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Gene-environment interactions are significantly contributory to bipolar affective disorder.
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There are pathologically altered neurobiological markers that play a role in the pathogenesis of bipolar disorder.
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There is an influence of anthropometric data on the course of bipolar disorder.
Statistical analysis and anticipated sample size:
Baseline data analysis will be investigated using a multi-factorial between subject design, with the variables of group (bipolar patients versus healthy controls), gender (males versus females), weight (normal weight versus overweight), etc. as independent factors, depending on the research question. As dependent variables, in addition to sociodemographic and clinical variables (number of episodes, etc.), physiological parameters (blood parameters, anthropometry and lipometer data, EEG, ECG, MRI) and psychological variables (psychological questionnaires) will be investigated. Likewise, covariates such as age or body mass index will be included as needed.
Correlation analyses (bivariate, partial) should show possible correlations between the variables. Discriminant analyses should find out which variable best separates the investigated groups (e.g. patients vs. controls). Furthermore, regression analyses (linear, multiple) will be performed to obtain additional information about the predictive value of the variables under investigation. All analyses will be computed using IBM SPSS Statistics 20.
For the "a priori analysis" of the follow-up study (T1-T5), a repeated measures design (repeated measures within factors) was adopted. The case number calculation (effect size d between .30 and .80; Cohen, 1988) for the F-test thus results in a sample size of 47 patients with a target effect size of .40 (power 95%; alpha .05; calculated with GPower 3.1). The correlation analyses at the first measurement time point (power .95, alpha .05, effect size: .35) yields 79 subjects per group (Pat. vs. controls) at all time-points.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients Patients with the Diagnosis of a Bipolar Disorder |
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| Healthy Controls Individuals with no diagnosis of Bipolar Disorder |
Outcome Measures
Primary Outcome Measures
- CVLT- california verbal learning test [at six months]
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
- STROOP Farbe-Wort-Interferenz-Test (FWIT) [at six months]
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.
- D2-R [at six months]
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.
- "Reading the eyes of the mind" =Theory of mind [at six months]
measurement of the ability to detect social cues. The higher the score, the better the outcome.
- Trail Making Test A/B, TMT-A [at six months]
Measurement of cognitive processing speed, as well as linguistic, executive, and attentional components. The lower the score, the better the outcome.
- Mehrfachwahl Wortschatz Test (MWT-B) [at six months]
Measurement of the general intelligence level. The higher the score, the better the outcome.
- Number Symbol Test [at six months]
Measurement of processing speed. The higher the score, the better the outcome.
- Number Repeat [at six months]
Measurement of working memory. The higher the score, the better the outcome.
- Beck Depressions Inventar II (BDI-II) [at six months]
Measurement of depression severity; 21 items on a scale of 0-3 (ascending). The higher the score, the worse the outcome.
- Manie-Selbstbeurteilungsskala (MSS) (self-rating scale) [at six months]
Measurement of manic symptoms; 48 items (dichotomous). The higher the score, the worse the outcome.
- Questionnaire of religiosity [at six months]
socio-demographic assesment of religiosity; 2 items.
- Big Five Inventory-10 (BFI-10) [at six months]
Measurement of personality variables; 10 items on a scale of 1-5 (ascending).
- World Health Organisation Quality of Life (WHOQOL Bref) [at six months]
Measurement of life-quality and health; 26 items on a scale of 1-5 (ascending).
- Life Event Questionnaire (LEQ) [at six months]
Measurement of life events and their influence; 79 items on a scale of 0-3 (ascending)
- Temperament and affective disorders (TEMPS-A)-Scale [at six months]
35 items on a scale of 1-5 (ascending). The higher the score, the better the outcome.
- Brief symptom inventory (BSI) [at six months]
Measurement of psychological symptoms; 53 items on a scale of 0-4 (ascending). The higher the score, the worse the outcome.
- Anhedonia scale (AS) [at six months]
Measurement of Anhedonia; 14 items on a scale of 1-4 (ascending). The higher the score, the worse the outcome.
- Maslach Burnout Inventory (MBI-GS-D) [at six months]
Measurement of burnout symptoms; 16 items on a scale of 1-6 (ascending). The higher the score, the worse the outcome.
- Resources in Sexuality and Partnership (RSP) [at six months]
Measurement of relationship emotions; 25 items on a scale of 1-5 (ascending).The higher the score, the better the outcome.
- Satisfaction in the couple relationship (ZIP) [at six months]
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.
- Demographic Data [at six months]
Measurement of demographic data
- Questionnaire of current life situation [at six months]
Measurement of demographic and diagnostic data;
- Anthropometric Data - weight [at six months]
Measurement of weight
- Anthropometric Data- height [at six months]
Measurement of height
- Anthropometric Data - waist-to-hip ratio [at six months]
Measurement of waist-to-hip ratio
- Anthropometric Data - blood pressure [at six months]
Measurement of blood pressure
- Clinical Global Impression (CGI) [at six months]
External rating of a symptom severity; 2 items on a scale of 0-7 (ascending). The higher the score, the better the outcome.
- Global Assessment Scale of Functioning (GAF) [at six months]
External rating of level of functioning; 1 item on a scale of 1-100 (ascending). The higher the score, the better the outcome.
- Hamilton Depression Scale (HAMD) [at six months]
External rating of depression symptoms; 21 items on a scale of 0-4 (ascending).The higher the score, the worse the outcome.
- Young Mania Rating Scale (YMRS) [at six months]
External rating of manic symptoms; 11 items on a scale of 0-4/0-8 (ascending). The higher the score, the worse the outcome.
- Specific Level of Functioning Assessment and Physical health Inventory (SLOF) [at six months]
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.
- Supplementary Data for External Rating [at six months]
External rating of bipolar symptoms; 7 items.
Eligibility Criteria
Criteria
Inclusion criteria:
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Pat. with bipolar disorder, with an age between 18 and 85 years.
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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).
Exclusion criteria:
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Pat. refuses participation
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Currently severely depressed/manic episode at the time of consent
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Other currently active severe mental/ brain organic disease (epilepsy, brain tumor..)
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St.p. severe craniocerebral trauma/ brain surgery.
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Reduced intelligence (IQ< 70)
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Moderate/ severe dementia (Mini Mental Status Examination, MMSE, 20 and above)
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Clearly substance-induced clinical picture
Inclusion criteria healthy controls:
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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)
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Inclusion criteria: 18-75 years, no severe mental illness (depression, mania, psychosis; severe anxiety or obsessive-compulsive disorder requiring treatment, addictive disorder other than nicotine).
Exclusion criteria:
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First-degree relatives with severe mental illness.
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Severe active drug dependence (i.e. alcohol, benzodiazepines morphines)
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Current major depressive/ manic episode
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Other currently active severe mental/ brain illness (epilepsy, brain tumor..)
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St.p. severe craniocerebral trauma/ brain surgery.
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Congenital/ early childhood acquired intelligence impairment
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Moderate/ severe dementia (from MMSE 20)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medical University Graz | Graz | Styria | Austria | 8036 |
Sponsors and Collaborators
- Medical University of Graz
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 25-355 ex 12/13