BIPLONG - The Bipolar Disorder in the Longitudinal Course

NCT ID: NCT05064995

Last Updated: 2021-10-01

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 560 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-06-13
• Study Completion Date: 2022-06-13

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.

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:

• Collection and analysis of DNA, establishment of permanent cell lines, determination of mRNA and gene products (proteins), proteomics, lipidomics.
• 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.
• 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
• 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:

• Gene-environment interactions are significantly contributory to bipolar affective disorder.
• There are pathologically altered neurobiological markers that play a role in the pathogenesis of bipolar disorder.
• 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.

Conditions

Bipolar Disorder

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients

Patients with the Diagnosis of a Bipolar Disorder

No interventions assigned to this group

Healthy Controls

Individuals with no diagnosis of Bipolar Disorder

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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).

• 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)

Exclusion Criteria

• 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

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical University Graz

Graz, Styria, Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Eva Reininghaus, MD, PhD, MBA

Role: CONTACT

eva.reininghaus@medunigraz.at

+43 316 385 80968

Nina Dalkner, PhD, MSc

Role: CONTACT

nina.dalkner@medunigraz.at

+43 316 385 30081

Facility Contacts

Eva Reininghaus, MD, PhD, MBA

Role: primary

eva.reininghaus@medunigraz.at

+43 316 385 80968

Nina Dalkner, PhD, MSc

Role: backup

nina.dalkner@medunigraz.at

+43 316 385 30081

Other Identifiers

25-355 ex 12/13

Identifier Type: -

Identifier Source: org_study_id