Female Experiences and Brain Activity (FEBA)
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Purpose
The Female Experiences and Brain Activity study will investigate how different groups of people process information in different ways. Using electro-physiological methods it will investigate differences in brain activity between women with ADHD, women with bipolar disorder and those without a psychiatric illness. It will also investigate the relationship between patterns of brain activity, mood and functioning.
| Condition |
|---|
|
Attention Deficit Hyperactivity Disorder ADHD Bipolar Disorder |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Cross-Sectional |
| Official Title: | Female Experiences and Brain Activity: an EEG Investigation Across Psychiatric Disorders |
- cognitive-electrophysiological recordings [ Time Frame: 2 hours ] [ Designated as safety issue: No ]Amplitude and latency of ERP components recorded by 64 scalp electrodes will be compared across groups. Comparison will be carried out by different types of ERP eliciting stimuli (target, non-target, novel, cue etc) from four different paradigms (ERN, CPT-OX with flankers, Fast-task, Novelty Oddball).
- Emotional and functional difficulties trait scores [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]Measures assessing ADHD/biploar symptoms traits, mood lability, and functional impairment will be used to generate an index of emotional regulation difficulties and resulting functional impairments. These will be be compared across groups and correlated with the primary ERP outcome measure.
- Genotype data from buccal swab samples [ Time Frame: 4 hours ] [ Designated as safety issue: No ]Extracted DNA will be genotyped for genetic markers (SNPs). Depending on results of the primary outcome measures, this information could be used to identify genetic regions associated with observed ERP deficits.
Biospecimen Retention: Samples With DNA
Buccal swab samples will be collected for DNA extraction.
| Estimated Enrollment: | 60 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Adult ADHD |
| Bipolar Disorder |
| Healthy control |
Detailed Description:
Attention deficit hyperactivity disorder (ADHD) and bipolar disorder (BD) affect approximately 2.5% and 1%, respectively, of the adult population in the UK. They represent a major clinical and economic burden on society. Genetic and environmental risk factors (such as life events for BD); have been identified for each disorder. Despite the highly different symptom presentations for ADHD and BD, it has recently become clear that they share a cognitive characteristic, observed in high response time variability (RTV). This has led to the question of whether the increased RTV, which reflects short-term fluctuations in performance, is a non-specific marker for psychopathology or whether the causes for the higher RTV could differ across disorders. RTV has been identified as a possible early marker of psychopathology; therefore a better understanding of the underlying mechanisms could lead to improved diagnosis and prevention of negative consequences. Further, it will give insight into the comorbidity observed between ADHD and BD. This study will use cognitive-electrophysiological methods to investigate the causes for RTV and its association with other cognitive and neurophysiological impairments observed in each disorder (aim 1). The second question will address whether, within each disorder, current cognitive functioning relates to the patients' current social functioning (aim 2). Adverse life events and other psychosocial risk factors can contribute to high variability in the level of social functioning observed, within and between individuals, in each disorder; yet our understanding of the association between current social functioning and cognitive functioning is limited. Finally the study will explore if any cognitive differences detected by electrophysiological investigation are associated with any candidate gene markers for either disorder (aim 3).
Eligibility| Ages Eligible for Study: | 25 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study population will be recruited through primary care clinics and existing research participant databases.
Inclusion Criteria:
- current clinical diagnosis of adult ADHD
- or current clinical diagnosis of Bipolar Disorder
- or no history of psychiatric illness
- white European descent
Exclusion Criteria:
- presence of a neurodevelopmental disorder
- epilepsy
- brain injury
- dyslexia
- limited proficiency in English language
- IQ<70
- any current psychiatric medication use (with the exception of mood stabilisers or stimulant medication in the clinical groups)
Contacts and Locations| Contact: Glenn Mould, BSc | +44 (0) 20 7848 0384 | glenn.mould@kcl.ac.uk |
| United Kingdom | |
| Institute of Psychiatry, King's College London | Recruiting |
| London, United Kingdom, SE5 8AF | |
| South London and Maudsley NHS Trust | Recruiting |
| London, United Kingdom, BR3 3BX | |
| Principal Investigator: | Philip Asherson, MRCPsych, PhD | King's College London |
More Information
No publications provided
| Responsible Party: | Glenn Mould, Project Coordinator, King's College London |
| ClinicalTrials.gov Identifier: | NCT01395160 History of Changes |
| Other Study ID Numbers: | 11/LO/0438 |
| Study First Received: | May 20, 2011 |
| Last Updated: | April 24, 2012 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by King's College London:
|
Attention deficit hyperactivity disorder ADHD Bipolar Disorder Electrophysiological EEG |
ERP Attention Motivation Mood instability |
Additional relevant MeSH terms:
|
Bipolar Disorder Attention Deficit Disorder with Hyperactivity Hyperkinesis Affective Disorders, Psychotic Mood Disorders Mental Disorders |
Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013