Bipolar DisorderBIPLONGNCT05064995
BIPLONG - The Bipolar Disorder in the Longitudinal Course
An observational study of Bipolar Disorder, run by Medical University of Graz at 1 site in Austria.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder
- How many people
- 560 participants
- Where
- 1 siteAustria
- Study dates
- 13 Jun 2013to 13 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with bipolar disorder and healthy controls within the age frame of 18-75 are included.
Who may be able to join
- 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)
- 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).
Who cannot join
- 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)
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- 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)
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University Graz
Graz, Styria, 8036
Eva Reininghaus, MD, PhD, MBA, +43 316 385 80968, eva.reininghaus@medunigraz.at
Nina Dalkner, PhD, MSc, +43 316 385 30081, nina.dalkner@medunigraz.at
About this study
Official title: 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.
Read the 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
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients with the Diagnosis of a Bipolar Disorder | |
| Healthy Controls | Individuals with no diagnosis of Bipolar Disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at six months
Mehrfachwahl Wortschatz Test (MWT-B)
Measurement of the general intelligence level. The higher the score, the better the outcome.
Measured: at six months
Number Symbol Test
Measurement of processing speed. The higher the score, the better the outcome.
Measured: at six months
Number Repeat
Measurement of working memory. The higher the score, the better the outcome.
Measured: 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.
Measured: at six months
Manie-Selbstbeurteilungsskala (MSS) (self-rating scale)
Measurement of manic symptoms; 48 items (dichotomous). The higher the score, the worse the outcome.
Measured: at six months
Questionnaire of religiosity
socio-demographic assesment of religiosity; 2 items.
Measured: at six months
Big Five Inventory-10 (BFI-10)
Measurement of personality variables; 10 items on a scale of 1-5 (ascending).
Measured: 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).
Measured: at six months
Life Event Questionnaire (LEQ)
Measurement of life events and their influence; 79 items on a scale of 0-3 (ascending)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at six months
Demographic Data
Measurement of demographic data
Measured: at six months
Questionnaire of current life situation
Measurement of demographic and diagnostic data;
Measured: at six months
Anthropometric Data - weight
Measurement of weight
Measured: at six months
Anthropometric Data- height
Measurement of height
Measured: at six months
Anthropometric Data - waist-to-hip ratio
Measurement of waist-to-hip ratio
Measured: at six months
Anthropometric Data - blood pressure
Measurement of blood pressure
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at six months
Supplementary Data for External Rating
External rating of bipolar symptoms; 7 items.
Measured: at six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start13 Jun 2013
- Primary completion13 Jun 2022 (estimated)
- Study completion13 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05064995
- Sponsor's protocol ID
- 25-355 ex 12/13
- Acronym
- BIPLONG
- Status last verified
- Sep 2021
- First submitted
- 14 Sep 2021
- Last updated
- 1 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Bipolar Disorder in the Longitudinal Course- Genom-wide Analysis of the genotype1 - phenotype2- Relationships in the Longitudinal Course of Psychosis
- ClinicalTrials.gov ID
- NCT05064995
- Acronym / sponsor ID
- BIPLONG / 25-355 ex 12/13
- Conditions
- Bipolar Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 13 Jun 2013 (actual)
- Primary completion
- 13 Jun 2022 (estimated)
- Study completion
- 13 Jun 2022 (estimated)
- First posted
- 1 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Patients with the Diagnosis of a Bipolar Disorder |
| Healthy Controls | – | –Individuals with no diagnosis of Bipolar Disorder |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with bipolar disorder and healthy controls within the age frame of 18-75 are included.
Key inclusion criteria (4 listed)
- 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)
- 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).
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
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.
"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.
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.
Mehrfachwahl Wortschatz Test (MWT-B)
Time frame: at six months
Measurement of the general intelligence level. The higher the score, the better the outcome.
Number Symbol Test
Time frame: at six months
Measurement of processing speed. The higher the score, the better the outcome.
Number Repeat
Time frame: at six months
Measurement of working memory. The higher the score, the better the outcome.
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.
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.
Questionnaire of religiosity
Time frame: at six months
socio-demographic assesment of religiosity; 2 items.
Big Five Inventory-10 (BFI-10)
Time frame: at six months
Measurement of personality variables; 10 items on a scale of 1-5 (ascending).
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).
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)
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.
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.
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.
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.
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.
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.
Demographic Data
Time frame: at six months
Measurement of demographic data
Questionnaire of current life situation
Time frame: at six months
Measurement of demographic and diagnostic data;
Anthropometric Data - weight
Time frame: at six months
Measurement of weight
Anthropometric Data- height
Time frame: at six months
Measurement of height
Anthropometric Data - waist-to-hip ratio
Time frame: at six months
Measurement of waist-to-hip ratio
Anthropometric Data - blood pressure
Time frame: at six months
Measurement of blood pressure
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.
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.
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.
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.
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.
Supplementary Data for External Rating
Time frame: at six months
External rating of bipolar symptoms; 7 items.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eva Reininghaus, MD, PhD, MBA (+43 316 385 80968, eva.reininghaus@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CVLT- california verbal learning test (time frame: at six months). The study lists 32 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2021.