Clinical Trials Logo

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

NCT number NCT05064995
Study type Observational
Source Medical University of Graz
Contact Eva Reininghaus, MD, PhD, MBA
Phone +43 316 385 80968
Email [email protected]
Status Recruiting
Start date June 13, 2013
Completion date June 13, 2022

See also
  Status Clinical Trial Phase
Completed NCT02855762 - Targeting the Microbiome to Improve Clinical Outcomes in Bipolar Disorder N/A
Completed NCT02513654 - Pharmacokinetics, Safety and Tolerability of Repeat Dosing Lamotrigine in Healthy Chinese Subjects Phase 1
Completed NCT02304432 - Targeting a Genetic Mutation in Glycine Metabolism With D-cycloserine Early Phase 1
Active, not recruiting NCT03497663 - VIA Family - Family Based Early Intervention Versus Treatment as Usual N/A
Recruiting NCT04284813 - Families With Substance Use and Psychosis: A Pilot Study N/A
Completed NCT02212041 - Electronic Cigarettes in Smokers With Mental Illness N/A
Recruiting NCT04298450 - ED to EPI: Using SMS to Improve the Transition From the Emergency Department to Early Psychosis Intervention N/A
Recruiting NCT03641300 - Efficacy of Convulsive Therapies for Bipolar Depression N/A
Not yet recruiting NCT04917419 - Nursing Care of Bipolar Patients With Sleeping Disorders Using Luminotherapy and /or Psychoeducation Program (BIPLUMINO) N/A
Not yet recruiting NCT05035316 - Effects of Low Dose Aspirin in Bipolar Disorder (The A-Bipolar RCT) Phase 2
Not yet recruiting NCT04432116 - Time and Virtual Reality in Schizophrenia and Bipolar Disorder N/A
Completed NCT02893371 - Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies
Terminated NCT02909504 - Gao NARASD Lithium Study Phase 4
Completed NCT02970721 - Use of Psychotropic Medications Among Pregnant Women With Bipolar Disorder
Recruiting NCT02466685 - Testing the Ability of JNJ-18038683 to Improve Cognition and Reduce Depressive Symptoms in Stable Bipolar Patients Phase 2
Recruiting NCT03088657 - Design and Methods of the Mood Disorder Cohort Research Consortium (MDCRC) Study
Recruiting NCT02527564 - Efficacy of Suvorexant to Treat Insomnia Related to Bipolar Disorder Phase 4
Recruiting NCT02481245 - BezafibrateTreatment for Bipolar Depression: A Proof of Concept Study Phase 2
Terminated NCT02727127 - Brain Ion Homeostasis, Lithium and Bipolar Disorder
Completed NCT02519543 - Treating Insulin Resistance as a Strategy to Improve Outcome in Refractory Bipolar Disorder Phase 3