Female Experiences and Brain Activity (FEBA)

August 30, 2013 updated by: Glenn Mould, King's College London

Female Experiences and Brain Activity: an EEG Investigation Across Psychiatric Disorders

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SE5 8AF
        • Institute of Psychiatry, King's College London
      • London, United Kingdom, BR3 3BX
        • South London and Maudsley NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Healthy control
Bipolar Disorder
Adult ADHD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 hours
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.
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College London

Collaborators

South London and Maudsley NHS Foundation Trust

Investigators

  • Principal Investigator: Philip Asherson, MRCPsych, PhD, King's College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

May 20, 2011

First Submitted That Met QC Criteria

July 14, 2011

First Posted (Estimate)

July 15, 2011

Study Record Updates

Last Update Posted (Estimate)

September 2, 2013

Last Update Submitted That Met QC Criteria

August 30, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11/LO/0438

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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