NCT07101107Recruiting

Socio-cognitive and Biological Responses to Maltreatment

Socio-cognitive and Biological Responses to Childhood Maltreatment in Individuals With Bipolar Disorder and Control Subjects

Source: ClinicalTrials.gov · Last updated 7 Oct 2026

Brief summary (registry, in English)

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.

Status (registry): Recruiting
Study type: Observational
Enrollment: 160 (estimated)
First submitted: 10 Jul 2025
Start date: 20 Jul 2026
Primary completion date: 28 Feb 2030
Lead sponsor: Medical University Innsbruck
Diseases: Bipolar disorder
NCT number: NCT07101107

What you commit to

Study type: Observational
Planned participants: 160
From 20 Jul 2026 to the primary completion date, 28 Feb 2030
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

currently on anti-inflammatory drugs, cortisol or cortisol derivates;
electroconvulsive therapy in the last 12 months;
current substance abuse (except caffeine and nicotine) as assessed by DSM-5 or positive urine drug screen;
MRI contraindications (e.g. claustrophobia, metal, electric, magnetic or mechanically driven implants); or
currently on anti-inflammatory drugs, cortisol or cortisol-derivates;

Other illness

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;
cardiovascular impairment with life-threatening issues;
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;

Other

IQ≤70 as assessed by the Mehrfachwahl-Wortschatztest" version B (MWT-B);
other ethical considerations (e.g. pregnancy, lactation, participants not fluent in the language of the cognitive batteries and questionnaires).
first degree relatives with BD, schizophrenia, or known genetically-based mitochondriopathies;
cardiovascular impairments with life-threatening issues;
current substance abuse;
IQ≤70;
MRI contraindications; or
other ethical considerations.

Who the study is looking for

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.
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.

Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Medical University of Innsbruck Coordinator of this site? Confirm its status	Innsbruck	Austria	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.