Female Experiences and Brain Activity (FEBA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01395160
Recruitment Status : Completed
First Posted : July 15, 2011
Last Update Posted : September 2, 2013
South London and Maudsley NHS Foundation Trust
Information provided by (Responsible Party):
Glenn Mould, King's College London

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.

Condition or disease
Attention Deficit Hyperactivity Disorder ADHD Bipolar Disorder

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).

Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Female Experiences and Brain Activity: an EEG Investigation Across Psychiatric Disorders
Study Start Date : July 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Adult ADHD
Bipolar Disorder
Healthy control

Primary Outcome Measures :
  1. cognitive-electrophysiological recordings [ Time Frame: 2 hours ]
    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).

  2. Emotional and functional difficulties trait scores [ Time Frame: 2 weeks ]
    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.

Secondary Outcome Measures :
  1. Genotype data from buccal swab samples [ Time Frame: 4 hours ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01395160

United Kingdom
South London and Maudsley NHS Trust
London, United Kingdom, BR3 3BX
Institute of Psychiatry, King's College London
London, United Kingdom, SE5 8AF
Sponsors and Collaborators
King's College London
South London and Maudsley NHS Foundation Trust
Principal Investigator: Philip Asherson, MRCPsych, PhD King's College London

Responsible Party: Glenn Mould, Project Coordinator, King's College London Identifier: NCT01395160     History of Changes
Other Study ID Numbers: 11/LO/0438
First Posted: July 15, 2011    Key Record Dates
Last Update Posted: September 2, 2013
Last Verified: August 2013

Keywords provided by Glenn Mould, King's College London:
Attention deficit hyperactivity disorder
Bipolar Disorder
Mood instability

Additional relevant MeSH terms:
Bipolar Disorder
Attention Deficit Disorder with Hyperactivity
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms