NCT07101107 Socio-cognitive and Biological Responses to Maltreatment
| NCT ID | NCT07101107 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University Innsbruck |
| Condition | Bipolar 1 Disorder |
| Study Type | OBSERVATIONAL |
| Enrollment | 160 participants |
| Start Date | 2026-07-20 |
| Primary Completion | 2030-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 160 participants in total. It began in 2026-07-20 with a primary completion date of 2030-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria for individuals diagnosed with bipolar disorder (BD): * diagnosis of a moderate to severe depressive episode without psychotic features in the context of BD-I according to the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5: 296.52 BD-I, most recent episode depressed, moderate; 296.53 BD-I, most recent episode depressed, severe without psychotic features; * Montgomery-Åsberg Depression Rating Scale (MADRS) score≥20; * age between 18 and 65 years; and * able to provide written informed consent for magnetic resonance imaging (MRI) and study participation. Exclusion Criteria for individuals diagnosed with BD: * a history of one or more diagnoses of the following DSM-5 categories: past or current moderate or severe substance dependence (303.x, 304.x, 305.x) with the exclusion of tobacco use disorder (305.1), neurodevelopmental disorders (299.x, 307.x, 314.x, 315.x, 319.x), schizophrenia spectrum and other psychotic disorders (293.x, 295.x, 297.x, 298.x), neurocognitive disorders (290.x, 292.x, 294.x, 331.x), BD-I Single Manic (296.0x), BD-I Manic (296.4x), BD-I Mixed (296.6, 296.7, 296.8, 296.9), BD-II (296.89), or comorbid Borderline Personality Disorder (BPD) as assessed by Structured Clinical Interview for DSM-5 Personality Disorders (SCID-5-PD); * a current episode of illness with psychotic features (296.54); * a recent history of central nervous system (CNS) trauma or significant CNS trauma; * physical illness that might interfere with the participant's cognitive performance; * an autoimmune disorder or inflammatory diseases; * currently on anti-inflammatory drugs, cortisol or cortisol derivates; * cardiovascular impairment with life-threatening issues; * electroconvulsive therapy in the last 12 months; * current substance abuse (except caffeine and nicotine) as assessed by DSM-5 or positive urine drug screen; * IQ≤70 as assessed by the Mehrfachwahl-Wortschatztest" version B (MWT-B); * MRI contraindications (e.g. claustrophobia, metal, electric, magnetic or mechanically driven implants); or * other ethical considerations (e.g. pregnancy, lactation, participants not fluent in the language of the cognitive batteries and questionnaires). Inclusion Criteria for healthy volunteers: * absence of any axis I disorder according to DSM-5 and physical illness that might interfere with participant's cognitive performance; * age between 18 and 65 years according to clinical group; and * ability to give written informed consent for MRI and study participation. Exclusion Criteria for healthy volunteers: * first degree relatives with BD, schizophrenia, or known genetically-based mitochondriopathies; * a history of any axis I disorder, neurological, developmental disorders, CNS trauma, or comorbid BPD. * physical illness that might interfere with the participants' cognitive performance; * an autoimmune disorder or inflammatory diseases; * currently on anti-inflammatory drugs, cortisol or cortisol-derivates; * cardiovascular impairments with life-threatening issues; * current substance abuse; * IQ≤70; * MRI contraindications; or * other ethical considerations.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07101107 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Bipolar 1 Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07101107 currently recruiting?
Yes, NCT07101107 is actively recruiting participants. Contact the research team at noora.tuovinen@i-med.ac.at for enrollment information.
Where is the NCT07101107 trial being conducted?
This trial is being conducted at Innsbruck, Austria.
Who is sponsoring the NCT07101107 clinical trial?
NCT07101107 is sponsored by Medical University Innsbruck. The trial plans to enroll 160 participants.
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