💬In plain words
What the trial is, and whether it could suit you
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,
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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