Clinical trial NCT01395160: Female Experiences and Brain Activity
Official title: Female Experiences and Brain Activity: an EEG Investigation Across Psychiatric Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Attention Deficit Hyperactivity Disorder
ADHD
Bipolar Disorder
Keywords: Attention deficit hyperactivity disorder
ADHD
Bipolar Disorder
Electrophysiological
EEG
ERP
Attention
Motivation
Mood instability
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: South London and Maudsley NHS Foundation Trust
First posted: 2011-07-15
Enrollment: 60
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will be recruited through primary care clinics and existing research participant databases.

Brief summary: 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.

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 criteria: 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)

Primary outcomes:
measure: cognitive-electrophysiological recordings
timeFrame: 2 hours
measure: Emotional and functional difficulties trait scores
timeFrame: 2 weeks
Secondary outcomes:
measure: Genotype data from buccal swab samples
timeFrame: 4 hours
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: South London and Maudsley NHS Trust
city: London
country: United Kingdom
facility: Institute of Psychiatry, King's College London
Study officials:
affiliation: King's College London
name: Philip Asherson, MRCPsych, PhD
role: PRINCIPAL_INVESTIGATOR
References: