An observational study in Bipolar 1 Disorder and Control Subjects, sponsored by Medical University Innsbruck. Recruiting at 1 site in Austria. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by Medical University Innsbruck · Observational
The study will investigate how a history of emotional childhood maltreatment (CM) is associated with different aspects of psychological (social behaviour, empathy) and biological (brain function and structure, inflammation) health. In fact, CM is a risk factor for many mental disorders, such as schizophrenia and autism. However, it is unclear how a history of emotional CM affects psychological and biological outcomes in bipolar disorder (BD). Therefore, this study focuses on understanding how a possible history of CM affects BD compared to control participants (CP) with no known psychiatric illness.
The aim of the project is to investigate how a history of emotional CM is associated with social cognition. The investigators will recruit 80 CP and 80 people diagnosed with BD, some of whom will have a history of CM. The investigators will assess psychological well-being (social behaviour, empathy) at two points in time at the Department of Psychiatry, Psychotherapy, Psychosomatics and Medical Psychology at the Medical University of Innsbruck (MUI). Additionally, as they want to understand how emotional CM affects brain function and structure, the investigators will perform magnetic resonance imaging (MRI) of the brain at the Neuroimaging Core Facility (Medical University of Innsbruck). The investigators also want to understand how biological markers in the blood (such as telomere length, inflammation) might be affected, assessed in collaboration with the Department of Psychology (Leopold-Franzens University of Innsbruck). Finally, the investigators will look at a combination of the psychological and biological tests to see if there is a link between emotional CM and health outcomes.
Although the contribution of childhood maltreatment (CM) to psychological (e.g. social cognition) and biological (e.g. neural, biomolecular) outcomes has been extensively studied, e.g. in schizophrenia and autism, its contribution to bipolar disorder (BD) and the role of different CM subtypes, multiplicity and timing remains unclear. The aim of the project is to investigate how a history of emotional CM is associated with multidimensional aspects of social cognitive, neural and biomolecular parameters.
The research questions addressed in this project are: i) How is a history of emotional CM associated with social cognition in control participants (CP) with no known psychiatric illness and in individuals diagnosed with BD? ii) How is a history of emotional CM related to biomolecular and neural parameters in CP and individuals diagnosed with BD? iii) How are biomolecular markers, neural parameters, and social cognitive skills related in individuals with a history of emotional CM? The primary aim of this study is to investigate the association of self-reported history of emotional CM with social cognition (i.e. emotion recognition, cognitive and affective empathy) in CP and in individuals diagnosed with BD, both with and without a history of CM. Additional aims are to characterize the association of history of emotional CM with neural (i.e. task-based and resting-state functional magnetic resonance imaging (rs-fMRI), morphometry, white matter) MRI parameters and biomolecular markers (i.e. telomere length, mitochondrial bioenergetics and biogenesis) in peripheral blood mononuclear cells and blood plasma (selected immune-response mediators).
Recruitment, clinical assessments (e.g. Maltreatment and Abuse Chronology of Exposure scale) and blood sampling of 80 CP and 80 individuals diagnosed with BD with and without a history of CM will be performed at two timepoints at the Department of Psychiatry, Psychotherapy, Psychosomatics and Medical Psychology, Medical University of Innsbruck (MUI). Longitudinal MRI acquisitions will be performed at the Neuroimaging Core Facility (MUI). Clinical, MRI and biomolecular analyses will be applied, and correlations of these findings with emotional CM, multiplicity and timing will be evaluated.
The contribution of a history of emotional CM to psychological and biological outcomes in BD is unknown. This study will clarify the association between emotional CM and social cognition in BD and CP. It will study how emotional CM alters brain function and structure in regions related to social cognition. A translational approach combining MR neuroimaging with psychoneuroimmunological methods will assess neural parameters together with biomolecular markers from whole blood in relation to emotional CM and social cognition.
1,683 studies on the registry are indexed under Bipolar Disorder; 266 are open to participants now.
This study's planned enrollment of 160 is close to the median of 159 across 348 observational studies indexed under Bipolar Disorder.
Browse Bipolar Disorder studies →Medical University Innsbruck is the lead sponsor of 186 studies on the registry; 47 are open to participants now.
Counted across the registry records on this site, refreshed daily.
For bipolar disorder with a current diagnosis of depressive episode: Inpatient clinic of the Department of Psychiatry, Psychotherapy, Psychosomatics and Medical Psychology of the Medical University Innsbruck.
For healthy controls: recruitment is done via public advertisements (e.g. posters, flyers, local newspaper announcements) and at the homepage of Medical University Innsbruck, Tirol Kliniken, and University of Innsbruck.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Inclusion Criteria for individuals diagnosed with bipolar disorder (BD):
Exclusion Criteria for individuals diagnosed with BD:
Inclusion Criteria for healthy volunteers:
Exclusion Criteria for healthy volunteers:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Correlation between a history of emotional childhood maltreatment score (Maltreatment and Abuse Chronology of Exposure; MACE-X) and emotion recognition of adult faces (Reading the Mind in the Eyes Test; RMET)
Correlation between a history of emotional childhood maltreatment score (as assessed by a combined score of the Maltreatment and Abuse Chronology of Exposure \[MACE-X\] emotional subscales: parental verbal abuse, parental nonverbal emotional abuse, emotional neglect, peer verbal abuse) and emotion recognition (number of correctly identified emotions) as assessed by the Reading the Mind in the Eyes Test adult version (RMET). RMET use expressions from images of 28 adult faces, 50% male and 50% female. The task consist of two types of trials: emotion recognition and sex judgment. In the emotion recognition trials, participants select among four adjectives the one that best describes what the person in the image is thinking or feeling. This task is sensitive to subtle emotion processing deficits since it involves the recognition of a relatively wide range of complex mental states.
Time frame: In bipolar disorder, at enrollment (in moderate or severe depressed state) and at improved clinical state (response or remission) at 3-6 months after enrollment. In control participants, at enrollment and at 3-6 months after.
Correlation between a history of emotional childhood maltreatment score (Maltreatment and Abuse Chronology of Exposure scale; MACE-X) and emotion recognition of child faces (Reading the Mind in the Eyes Test; RME-C-T)
Correlation between a history of emotional childhood maltreatment score (Maltreatment and Abuse Chronology of Exposure scale; MACE-X) and emotion recognition (number of correctly identified emotions) as assessed the Reading the Mind in the Eyes Test child version (RME-C-T). RME-C-T uses high-quality pictures of 28 child faces. The task consist of two types of trials: emotion recognition and sex judgment. In the emotion recognition trials, participants select among four adjectives the one that best describes what the person in the image is thinking or feeling.
Time frame: In bipolar disorder, at enrollment (in moderate or severe depressed state) and at improved clinical state (response or remission) at 3-6 months after enrollment. In control participants, at enrollment and at 3-6 months after.
Correlation between a history of emotional childhood maltreatment score (Maltreatment and Abuse Chronology of Exposure scale; MACE-X) and cognitive empathy (Multifaceted Empathy Test; MET-core 2)
Correlation between a history of emotional childhood maltreatment score (Maltreatment and Abuse Chronology of Exposure scale; MACE-X) and cognitive empathy (number of correctly identified) as assessed by The Multifaceted Empathy Test (MET-core 2). MET-core 2 is an ecologically valid measure that allows separate assessment of cognitive and affective empathy. It consists of 40 photographs depicting people in emotionally charged situations and is designed to elicit strong emotional reactions. To assess cognitive empathy ("What is the person feeling?"), the mental states of the people in the photographs are selected from four mental state descriptors. To assess affective empathy ("How much are you feeling for the person?"), the level of empathic concern for the depicted individuals is rated on a 4-point Likert scale (from "not at all" to "very strong") for the same series of pictures.
Time frame: In bipolar disorder, at enrollment (in moderate or severe depressed state) and at improved clinical state (response or remission) at 3-6 months after enrollment. In control participants, at enrollment and at 3-6 months after.
Correlation between a history of emotional childhood maltreatment score (Maltreatment and Abuse Chronology of Exposure scale; MACE-X) and affective empathy (Multifaceted Empathy Test; MET-core 2)
Correlation between a history of emotional childhood maltreatment score (Maltreatment and Abuse Chronology of Exposure scale; MACE-X) and affective empathy (rating) as assessed by The Multifaceted Empathy Test (MET-core 2). MET-core 2 is an ecologically valid measure that allows separate assessment of cognitive and affective empathy. It consists of 40 photographs depicting people in emotionally charged situations and is designed to elicit strong emotional reactions. To assess cognitive empathy ("What is the person feeling?"), the mental states of the people in the photographs are selected from four mental state descriptors. To assess affective empathy ("How much are you feeling for the person?"), the level of empathic concern for the depicted individuals is rated on a 4-point Likert scale for the same series of pictures.
Time frame: In bipolar disorder, at enrollment (in moderate or severe depressed state) and at improved clinical state (response or remission) at 3-6 months after enrollment. In control participants, at enrollment and at 3-6 months after.
Correlation between a history of emotional childhood maltreatment score (Maltreatment and Abuse Chronology of Exposure scale; MACE-X) and brain morphometry (T1-weighted imaging)
Correlation between a history of emotional childhood maltreatment score (Maltreatment and Abuse Chronology of Exposure scale; MACE-X) and brain morphometry (T1-weighted MRI). The research hypothesis is that increasing severity of a history of emotional childhood maltreatment will correlate with small limbic volumes (e.g. hippocampi, amygdala, thalamus). These changes in morphometry will be more pronounced in bipolar disorder compared to control participants.
Time frame: At enrollment (bipolar disorder with moderate or severe depressed state) and at improved clinical state (response or remission) at 3-6 months after enrollment. In control participants, at enrollment and at 3-6 months after.
Correlation between a history of emotional childhood maltreatment score (Maltreatment and Abuse Chronology of Exposure scale; MACE-X) and brain responses (task-based fMRI)
Correlation between a history of emotional childhood maltreatment score (Maltreatment and Abuse Chronology of Exposure scale; MACE-X) and brain responses (task-based functional MRI). In control participant, the hypothesis is that increasing severity of a history of emotional childhood maltreatment will correlate with: i) low brain responses during RMET/RME-C-T (along with correct and rapid identification of negative emotions) in social cognitive brain regions (e.g. temporoparietal junction, medial prefrontal cortex, amygdala, insula); ii) high brain responses during MET-Core 2 (along with high cognitive and affective empathy abilities). In bipolard disorder, increasing severity of a history of emotional childhood maltreatment will correlate with: i) high brain responses during RMET/RME-C-T in social cognitive regions (along with incorrect and slow identification of negative emotions) ii) low brain responses during MET-Core 2 (along with low cognitive and affective empathy abilities).
Time frame: At enrollment (bipolar disorder with moderate or severe depressed state) and at improved clinical state (response or remission) at 3-6 months after enrollment. In control participants, at enrollment and at 3-6 months after.
Correlation between a history of emotional childhood maltreatment score (Maltreatment and Abuse Chronology of Exposure scale; MACE-X) and brain functional connectivity (resting-state functional MRI).
Correlation between a history of emotional childhood maltreatment score (Maltreatment and Abuse Chronology of Exposure scale; MACE-X) and brain functional connectivity (resting-state functional MRI). The hypothesis is that increasing severity of a history of emotional childhood maltreatment will correlate low functional connectivity within the Theory-of-Mind (ToM) network. These changes in functional connectivity will be more pronounced in bipolar disorder compared to control participants. Both cognitive and affective ToM tasks involve the posterior temporoparietal junction, the posterior superior temporal sulcus, and the posterior cingulate cortex. While cognitive ToM involves the dorsolateral prefrontal cortex (PFC), dorsal striatum, dorsal anterior cingulate cortex (ACC), and dorsomedial PFC, affective ToM involves the inferior frontal gyrus, insula, ventral striatum, amygdala, temporal poles, ACC, and medial PFC.
Time frame: At enrollment (bipolar disorder with moderate or severe depressed state) and at improved clinical state (response or remission) at 3-6 months after enrollment. In control participants, at enrollment and at 3-6 months after.
Correlation between a history of emotional childhood maltreatment score (Maltreatment and Abuse Chronology of Exposure scale; MACE-X) and brain white matter values (diffusion MRI)
Correlation between a history of emotional childhood maltreatment score (Maltreatment and Abuse Chronology of Exposure scale; MACE-X) and brain white matter values (diffusion MRI). The hypothesis is that increasing severity of a history of emotional childhood maltreatment will correlate with disruption (e.g. low fractional anisotropy values) in white matter tracts connecting social cognitive regions (e.g. superior longitudinal fasciculus, cingulum, uncinate fasciculus, corpus callosum). These changes in white matter will be more pronounced in bipolar disorder compared to control participants.
Time frame: At enrollment (bipolar disorder with moderate or severe depressed state) and at improved clinical state (response or remission) at 3-6 months after enrollment. In control participants, at enrollment and at 3-6 months after.
Correlation between a history of emotional childhood maltreatment score (Maltreatment and Abuse Chronology of Exposure scale; MACE-X) and inflammation
Correlation between a history of emotional childhood maltreatment score (Maltreatment and Abuse Chronology of Exposure scale; MACE-X) and inflammation (measured from blood samples). The hypothesis is that increasing severity of a history of emotional childhood maltreatment is correlated with higher inflammation levels (e.g. CRP, IL-1β, IL-6, TNF-α). High levels of inflammation will be more pronounced in bipolar disorder compared to control participants.
Time frame: In bipolar disorder, at enrollment (in moderate or severe depressed state) and at improved clinical state (response or remission) at 3-6 months after enrollment. In control participants, at enrollment and at 3-6 months after.
Correlation between a history of emotional childhood maltreatment score (Maltreatment and Abuse Chronology of Exposure scale; MACE-X) and telomere length
Correlation between a history of emotional childhood maltreatment score (Maltreatment and Abuse Chronology of Exposure scale; MACE-X) and telomere length (measured from blood samples). The hypothesis is that increasing severity of a history of emotional childhood maltreatment is correlated with telomere shortening. Telomere shortening will be more pronounced in bipolar disorder compared to control participants.
Time frame: In bipolar disorder, at enrollment (in moderate or severe depressed state) and at improved clinical state (response or remission) at 3-6 months after enrollment. In control participants, at enrollment and at 3-6 months after.
Correlation between a history of emotional childhood maltreatment score (Maltreatment and Abuse Chronology of Exposure scale; MACE-X) and mitochondrial bioenergetics and biogenesis
Correlation between a history of emotional childhood maltreatment score (Maltreatment and Abuse Chronology of Exposure scale; MACE-X) and mitochondrial bioenergetics and biogenesis (measured from blood samples). The hypothesis is that in control participants increasing severity of a history of emotional childhood maltreatment is correlated with high mitochondria function (e.g. high mitochondrial respiratory activity and density as a compensatory effect of chronic stress) whereas in bipolar disorder it will correlate with impairments in mitochondria function.
Time frame: In bipolar disorder, at enrollment (in moderate or severe depressed state) and at improved clinical state (response or remission) at 3-6 months after enrollment. In control participants, at enrollment and at 3-6 months after.
Correlation between a history of emotional childhood maltreatment score (Maltreatment and Abuse Chronology of Exposure scale; MACE-X) and and gaze pattern (as studied with eye-tracking)
Correlation between a history of emotional childhood maltreatment score (Maltreatment and Abuse Chronology of Exposure scale; MACE-X) and gaze pattern (as studied with eye-tracking) within the eye region during the RMET. The hypothesis is that increasing severity of a history of emotional childhood maltreatment will correlate with reduced attention to the eye region. These changes will be more pronounced in bipolar disorder compared to control participants.
Time frame: At enrollment (bipolar disorder with moderate or severe depressed state) and at improved clinical state (response or remission) at 3-6 months after enrollment. In control participants, at enrollment and at 3-6 months after.
Illness effects and stability of self-reported childhood maltreatment assessment
Change in the baseline and follow-up (3 to 6 months) assessments of self-reported childhood maltreatment (Maltreatment and Abuse Chronology of Exposure scale; MACE-X) data are used to study the illness effects in bipolar disorder and stability of assessments in control participants.
Time frame: Between enrollment (depressive) and improved clinical states (remission, response) at 3-6 months after enrollment in bipolar disorder. In control participants, at enrollment and at 3-6 months after.
Illness effects and stabilitity of emotion recognition (RME-C-T)
Change in the baseline and follow-up (3 to 6 months) assessment of emotion recognition (number of correctly identified emotions) as assessed the Reading the Mind in the Eyes Test child version (RME-C-T) is used to study the illness effects in bipolar disorder and stability of assessments in control participants.
Time frame: Between enrollment (depressive) and improved clinical states (remission, response) at 3-6 months after enrollment in bipolar disorder. In control participants, at enrollment and at 3-6 months after.
Illness effects and stabilitity of emotion recognition (RMET)
Change in the baseline and follow-up (3 to 6 months) assessment of emotion recognition (number of correctly identified emotions) as assessed by the Reading the Mind in the Eyes Test adult version (RMET) is used to study the illness effects in bipolar disorder and stability of assessments in control participants.
Time frame: Between enrollment (depressive) and improved clinical states (remission, response) at 3-6 months after enrollment in bipolar disorder. In control participants, at enrollment and at 3-6 months after.
Illness effects and stabilitity of cognitive empathy (MET-core 2)
Change in the baseline and follow-up (3 to 6 months) assessment of cognitive empathy (number of correctly identified) as assessed by The Multifaceted Empathy Test (MET-core 2) is used to study the illness effects in bipolar disorder and stability of assessments in control participants.
Time frame: Between enrollment (depressive) and improved clinical states (remission, response) at 3-6 months after enrollment in bipolar disorder. In control participants, at enrollment and at 3-6 months after.
Illness effects and stabilitity of affective empathy (MET-core 2)
Change in the baseline and follow-up (3 to 6 months) assessment of affective empathy (rating) as assessed by The Multifaceted Empathy Test (MET-core 2) is used to study the illness effects in bipolar disorder and stability of assessments in control participants.
Time frame: Between enrollment (depressive) and improved clinical states (remission, response) at 3-6 months after enrollment in bipolar disorder. In control participants, at enrollment and at 3-6 months after.
Illness effects and stability of brain responses (task-based fMRI responses)
Change in the baseline and follow-up (3 to 6 months) assessments of brain responses during task-based fMRI (RME-C-T, RMET, MET-core-2) are used to study the illness effects in bipolar disorder and stability of assessments in control participant
Time frame: Between enrollment (depressive) and improved clinical states (remission, response) at 3-6 months after enrollment in bipolar disorder. In control participants, at enrollment and at 3-6 months after.
Illness effects and stability of brain functional connectivity (resting-state fMRI)
Change in the baseline and follow-up (3 to 6 months) assessments of brain functional connectivity (resting-state fMRI) are used to study the illness effects in bipolar disorder and stability of assessments in control participants.
Time frame: Between enrollment (depressive) and improved clinical states (remission, response) at 3-6 months after enrollment in bipolar disorder. In control participants, at enrollment and at 3-6 months after.
Illness effects and stability of brain white matter values (diffusion MRI)
Change in the baseline and follow-up (3 to 6 months) assessments of brain white matter values (diffusion MRI) are used to study the illness effects in bipolar disorder and stability of assessments in control participants.
Time frame: Between enrollment (depressive) and improved clinical states (remission, response) at 3-6 months after enrollment in bipolar disorder. In control participants, at enrollment and at 3-6 months after.
Illness effects and stability of brain morphometry (T1-weighted imaging)
Change in the baseline and follow-up (3 to 6 months) assessments of brain morphometry (T1-weighted imaging) are used to study the illness effects in bipolar disorder and stability of parameters in control participants.
Time frame: Between enrollment (depressive) and improved clinical states (remission, response) at 3-6 months after enrollment in bipolar disorder. In control participants, at enrollment and at 3-6 months after.
Illness effects and stability of telomere length
Change in the baseline and follow-up (3 to 6 months) telomere length (assessed from blood samples) are used to study the illness effects in bipolar disorder and stability of assessments in control participants.
Time frame: Between enrollment (depressive) and improved clinical states (remission, response) at 3-6 months after enrollment in bipolar disorder. In control participants, at enrollment and at 3-6 months after.
Illness effects and stability of mitochondrial bioenergetics and biogenesis
Change in the baseline and follow-up (3 to 6 months) mitochondrial bioenergetics and biogenesis (assessed from blood samples) are used to study the illness effects in bipolar disorder and stability of assessments in control participants.
Time frame: Between enrollment (depressive) and improved clinical states (remission, response) at 3-6 months after enrollment in bipolar disorder. In control participants, at enrollment and at 3-6 months after.
Illness effects and stability of inflammatory parameters
Change in the baseline and follow-up (3 to 6 months) of inflammatory (assessed from blood samples) parameters are used to study the illness effects in bipolar disorder and stability of assessments in control participants
Time frame: Between enrollment (depressive) and improved clinical states (remission, response) at 3-6 months after enrollment in bipolar disorder. In control participants, at enrollment and at 3-6 months after.
Psychological distress with the Mini-Symptom-Checklist (Mini-SCL)
The Mini-Symptom-Checklist (Mini-SCL) assesses symptomatic stress with 18 questions on a Likert scale ranging from 0 (not at all) to 4 (very strongly). Higher scores on the Mini-SCL indicate higher levels of psychological distress or symptom severity
Time frame: In bipolar disorder, at enrollment (in moderate or severe depressed state) and at improved clinical state (response or remission) at 3-6 months after enrollment. In control participants, at enrollment and at 3-6 months after.
Brief Assessment of Cognition in Schizophrenia (BACS)
The Brief Assessment of Cognition in Schizophrenia (BACS) is used to rule out impairment in non-social cognition, i.e. verbal memory, working memory, motor speed, verbal fluency, attention and processing speed, and executive functions. It has high reliability and has been validated in several languages. BACS raw values are converted into T values with a mean of 50 and a standard deviation of 10. In summary, while there isn't a fixed maximum or minimum score, lower BACS scores (especially when below -1 or -2 on the Z-score scale) are indicative of cognitive deficits. The BACS was originally developed for schizophrenia but has been used in individuals diagnosed with bipolar disorder who achieved lower scores in the composite and most subtest scores compared to control participants.
Time frame: In bipolar disorder, at enrollment (in moderate or severe depressed state) and at improved clinical state (response or remission) at 3-6 months after enrollment. In control participants, at enrollment and at 3-6 months after.
Mini-International Neuropsychiatric Interview (M.I.N.I.)
Any Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 psychiatric disorders will be screened with Mini-International Neuropsychiatric Interview (M.I.N.I.) version 7.0.2 on the recruitment stage. The M.I.N.I. is a validated, structured, diagnostic interview tool with high diagnostic reliability, consisting of questions that parallel symptoms in the DSM. M.I.N.I. has 17 modules. Each question within a module is answered with a "yes" or "no". A "yes" answer contributes one point to the module's score. Clinicians sum the positive responses to determine the module score, which indicates whether the participant meets the diagnostic criteria for that particular disorder.
Time frame: At screening
The Montgomery-Åsberg Depression Rating Scale (MADRS)
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item questionnaire used to determine the degree of depressive symptoms in individuals diagnosed with bipolar disorder and subclinical depression in control participants. Each item yields a score ranging from 0 to 6, and the overall score ranges from 0 to 60. Higher MADRS scores indicate more severe depressive symptoms.
Time frame: In bipolar disorder, at enrollment (in moderate or severe depressed state) and at improved clinical state (response or remission) at 3-6 months after enrollment.
German multiple-choice vocabulary test MWT-B
IQ is assessed with German multiple-choice vocabulary test (MWT-B). It assesses crystallized intelligence. It consists of 37 items of multiple choice (5 words) vocabulary test. One of the answers is correct. Maximum of 37 correct words corresponds to IQ=120.
Time frame: Screening
Young Mania Rating Scale (YMRS)
Young Mania Rating Scale (YMRS) assesses the severity of manic symptoms with 11 items. The overall score ranges from 0 to 60 with higher scores indicating more severe mania. Each item is scored either on a 0 to 4 scale (7 items) or with twice the scaling weight from 0 to 8 (4 items).
Time frame: In bipolar disorder, at enrollment (in moderate or severe depressed state) and at improved clinical state (response or remission) at 3-6 months after enrollment.
Structured Clinical Interview for DSM-5 Personality Disorders (SCID-5-PD)
Comorbid borderline personality disorder is assessed by Structured Clinical Interview for DSM-5 Personality Disorders (SCID-5-PD). It is used to assess comorbid borderline personality disorder traits (14 questions) which are often found in an interaction between bipolar disorder and childhood maltreatment. Higher scores indicate a greater severity of personality pathology.
Time frame: Screening
Toronto Alexithymia Scale (TAS)
The Toronto Alexithymia Scale (TAS) consists of 20 statements on a 5-point Likert scale which measure participants' difficulties in identifying or describing their own emotions (1=strongly disagree/5=strongly agree), and their externally oriented thinking style which allows reliable discrimination of alexithymic and non-alexithymic individuals. The TAS-20 has 3 subscales: Difficulty Describing Feelings, Difficulty Identifying Feeling, and Externally-Oriented Thinking. There are 5 items that are negatively keyed. The total alexithymia score is the sum of responses to all 20 items, while the score for each subscale factor is the sum of the responses to that subscale. The TAS-20 uses cutoff scoring: equal to or less than 51 = non-alexithymia, equal to or greater than 61 = alexithymia. Scores of 52 to 60 =possible alexithymia. MET and RMET performance correlates negatively with TAS scores, which is expected as empathetic traits facilitate and alexithymic traits impair emotion recognition.
Time frame: In bipolar disorder, at enrollment (in moderate or severe depressed state) and at improved clinical state (response or remission) at 3-6 months after enrollment. In control participants, at enrollment and at 3-6 months after.
Interpersonal Reactivity Index (IRI)
The IRI consists of 28 statements on a 5-point Likert scale (scored from 0 to 4) which requires participants to decide on other-directed thoughts and feelings (Does not describe me well/Describes me very well), and is a widely used multidimensional measure of trait empathy. The measure has 4 subscales, each made up of 7 different items: Perspective taking (PT), Fantasy (FS), Empathic concern (EC), and Personal Distress (PD), where higher scores generally indicate a greater tendency towards empathy. MET and RMET performance correlates positively with IRI, which is expected as empathetic traits facilitate and alexithymic traits impair emotion recognition. EC and PD scales have been referred to as measuring affective empathy while the PT and FS scale are commonly referred to as measuring cognitive empathy.
Time frame: In bipolar disorder, at enrollment (in moderate or severe depressed state) and at improved clinical state (response or remission) at 3-6 months after enrollment. In control participants, at enrollment and at 3-6 months after.
The resource allocation task (RAT-6)
The resource allocation task (RAT-6) measures prosociality with 6 decisions regarding the imaginary split of money between the participant and another person, where nine options are given. The set of responses can then be scored to yield a single score, the rank order of social preferences (altruistic, prosocial, individualistic, and competitive), and additionally contains a check for transitivity in revealed preferences. Given the angles that result from idealized SVO types, proper boundaries between categories can be derived by bisecting the respective adjacent ranges. Altruists would have an angle greater than 57.15◦; prosocials would have angles between 22.45◦ and 57.15◦; individualists would have angles between -12.04◦ and 22.45◦ ; and competitive types would have an angle less than -12.04◦. Mindreading performance predicts RAT performance which indicates its real consequences on social behavior.
Time frame: In bipolar disorder, at enrollment (in moderate or severe depressed state) and at improved clinical state (response or remission) at 3-6 months after enrollment. In control participants, at enrollment and at 3-6 months after.
Benevolent Childhood Experiences (BCEs)
BCEs is a 20-item self-report measure used retrospectively to assess positive childhood experiences from birth to age 18 years. BCEs scale evaluates multisystem positive experiences that serve as assets and resources for developing children. The BCEs scale also measures two primary dimensions of positive childhood experiences: 1) Common Protective Factors - assesses the presence of frequently reported protective childhood experiences, capturing internal and relational safety and security (e.g., having at least one safe caregiver, a good friend, a supportive teacher) and a positive, predictable quality of life, and 2) Discriminating Protective Factors - evaluates the presence of experiences such as beliefs that provide comfort, positive self-image, fair treatment, and regular access to restorative factors (like good sleep and time outdoors).
Time frame: In bipolar disorder, at improved clinical state (response or remission) at 3-6 months after enrollment. In control participants, at 3-6 months after enrollment.
International Trauma Exposure Measure (ITEM)
Traumatic exposure is assessed using the ITEM, which is a freely available checklist measuring 21 threatening life events. Sixteen events reflect the DSM-5 definition of trauma exposure (i.e., direct or indirect threat to life, or to physical or sexual safety). The other five events are psychologically threatening events that can be considered traumatic in line with ICD-11 guidelines. Respondents indicate if they experienced each event during three developmental periods (0-12 years, 13-18 years, and older than 18 years). Lifetime exposure to each event is indicated by a positive response in any of the developmental periods. Respondents identify their most distressing event (their index trauma), how many times this event occurred, and how long ago it first occurred.
Time frame: In bipolar disorder, at improved clinical state (response or remission) at 3-6 months after enrollment. In control participants, at 3-6 months after enrollment
Childhood Trauma Questionnaire (CTQ)
The CTQ consists of 25 questions and three validity items which comprise five subscales: emotional, physical, and sexual abuse, as well as emotional and physical neglect. Each scale is represented with five items that are scored on a 5-point Likert scale (1=never true, 5=very often true) according to the frequency with which each event occurred.
Time frame: In bipolar disorder, at enrollment (in moderate or severe depressed state). In control participants, at enrollment.
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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