Female Experiences and Brain Activity

NCT01395160 | Completed

• 1 other identifier: 11/LO/0438
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Attention Deficit Hyperactivity Disorder; ADHD; Bipolar Disorder

Keywords

Attention deficit hyperactivity disorder; ADHD; Bipolar Disorder; Electrophysiological; EEG; ERP; Attention; Motivation; Mood instability

Outcome Measures

Primary Outcomes (2)

• cognitive-electrophysiological recordings

  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

  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 Outcomes (1)

• Genotype data from buccal swab samples

  4 hours

Study Arms (3)

Adult ADHD

Bipolar Disorder

Healthy control

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• current clinical diagnosis of adult ADHD
• or current clinical diagnosis of Bipolar Disorder
• or no history of psychiatric illness
• white European descent

You may not qualify if:

• 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)

Sponsors & Collaborators

• King's College London: lead
• South London and Maudsley NHS Foundation Trust: collaborator

Study Sites (2)

South London and Maudsley NHS Trust

London, London, BR3 3BX, United Kingdom

Location

Institute of Psychiatry, King's College London

London, London, SE5 8AF, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Buccal swab samples will be collected for DNA extraction.

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Bipolar Disorder

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders

Study Officials

• Philip Asherson, MRCPsych, PhD

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project Coordinator

Study Record Dates

• First Submitted: May 20, 2011
• First Posted: July 15, 2011
• Study Start: July 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: September 2, 2013

Record last verified: 2013-08

Locations

GB (2)