How childhood emotional maltreatment relates to social thinking and biology in bipolar disorder and healthy people

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study compares 80 people with bipolar I disorder and 80 control participants, focusing on how self-reported emotional childhood maltreatment relates to social cognition, empathy, and neural and biomolecular measures. It uses MRI to assess brain structure and function, and biomarker analyses to explore inflammation and related processes, at two time points. Participants are adults aged 18–65 and will undergo brain imaging and psychological assessments in a controlled setting at the Medical University Innsbruck and collaborating sites. The research aims to clarify whether emotional CM differentially affects social cognitive skills and biological markers in BD versus controls. The project also explores how neural, biomolecular, and social cognitive data interrelate in the context of emotional CM.

Why it matters

Who can join: the full rules

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.

Where it's running

• Medical University of Innsbruck
  Innsbruck, Tyrol, Austria Recruiting

Study contacts

• Study coordinator: Noora Tuovinen, PhD
• Email: noora.tuovinen@i-med.ac.at
• Phone: +4351250483819

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.