BIPLONG - The Bipolar Disorder in the Longitudinal Course (BIPLONG)

September 23, 2021 updated by: Medical University of Graz

The Bipolar Disorder in the Longitudinal Course- Genom-wide Analysis of the genotype1 - phenotype2- Relationships in the Longitudinal Course of Psychosis

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
560

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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).

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

Inclusion criteria healthy controls:

  • 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)
  • 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:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Patients
Patients with the Diagnosis of a Bipolar Disorder
Healthy Controls
Individuals with no diagnosis of Bipolar Disorder

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
CVLT- california verbal learning test
Time Frame: 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
at six months
STROOP Farbe-Wort-Interferenz-Test (FWIT)
Time Frame: 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.
at six months
D2-R
Time Frame: 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.
at six months
"Reading the eyes of the mind" =Theory of mind
Time Frame: at six months
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
Time Frame: at six months
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)
Time Frame: at six months
Measurement of the general intelligence level. The higher the score, the better the outcome.
at six months
Number Symbol Test
Time Frame: at six months
Measurement of processing speed. The higher the score, the better the outcome.
at six months
Number Repeat
Time Frame: at six months
Measurement of working memory. The higher the score, the better the outcome.
at six months
Beck Depressions Inventar II (BDI-II)
Time Frame: at six months
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)
Time Frame: at six months
Measurement of manic symptoms; 48 items (dichotomous). The higher the score, the worse the outcome.
at six months
Questionnaire of religiosity
Time Frame: at six months
socio-demographic assesment of religiosity; 2 items.
at six months
Big Five Inventory-10 (BFI-10)
Time Frame: at six months
Measurement of personality variables; 10 items on a scale of 1-5 (ascending).
at six months
World Health Organisation Quality of Life (WHOQOL Bref)
Time Frame: at six months
Measurement of life-quality and health; 26 items on a scale of 1-5 (ascending).
at six months
Life Event Questionnaire (LEQ)
Time Frame: at six months
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
Time Frame: at six months
35 items on a scale of 1-5 (ascending). The higher the score, the better the outcome.
at six months
Brief symptom inventory (BSI)
Time Frame: at six months
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)
Time Frame: at six months
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)
Time Frame: at six months
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)
Time Frame: at six months
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)
Time Frame: 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.
at six months
Demographic Data
Time Frame: at six months
Measurement of demographic data
at six months
Questionnaire of current life situation
Time Frame: at six months
Measurement of demographic and diagnostic data;
at six months
Anthropometric Data - weight
Time Frame: at six months
Measurement of weight
at six months
Anthropometric Data- height
Time Frame: at six months
Measurement of height
at six months
Anthropometric Data - waist-to-hip ratio
Time Frame: at six months
Measurement of waist-to-hip ratio
at six months
Anthropometric Data - blood pressure
Time Frame: at six months
Measurement of blood pressure
at six months
Clinical Global Impression (CGI)
Time Frame: 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.
at six months
Global Assessment Scale of Functioning (GAF)
Time Frame: 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.
at six months
Hamilton Depression Scale (HAMD)
Time Frame: 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.
at six months
Young Mania Rating Scale (YMRS)
Time Frame: 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.
at six months
Specific Level of Functioning Assessment and Physical health Inventory (SLOF)
Time Frame: 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.
at six months
Supplementary Data for External Rating
Time Frame: at six months
External rating of bipolar symptoms; 7 items.
at six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of Graz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 13, 2013

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 13, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 13, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 1, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 25-355 ex 12/13

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bipolar Disorder

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings