Female Experiences and Brain Activity (FEBA)

This study has been completed.
Sponsor:
Collaborator:
South London and Maudsley NHS Foundation Trust
Information provided by (Responsible Party):
Glenn Mould, King's College London
ClinicalTrials.gov Identifier:
NCT01395160
First received: May 20, 2011
Last updated: August 30, 2013
Last verified: August 2013
  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

Resource links provided by NLM:


Further study details as provided by King's College London:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 60
Study Start Date: July 2011
Study Completion Date: November 2012
Primary Completion Date: November 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

Study population will be recruited through primary care clinics and existing research participant databases.

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01395160

Locations
United Kingdom
Institute of Psychiatry, King's College London
London, United Kingdom, SE5 8AF
South London and Maudsley NHS Trust
London, United Kingdom, BR3 3BX
Sponsors and Collaborators
King's College London
South London and Maudsley NHS Foundation Trust
Investigators
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: August 30, 2013
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 July 23, 2014