Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-29 @ 2:28 AM
Study NCT ID:
NCT01395160
Status:
COMPLETED
Last Update Posted:
2013-09-02
First Post:
2011-05-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Female Experiences and Brain Activity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}, {'id': 'D001714', 'term': 'Bipolar Disorder'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Buccal swab samples will be collected for DNA extraction.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-30', 'studyFirstSubmitDate': '2011-05-20', 'studyFirstSubmitQcDate': '2011-07-14', 'lastUpdatePostDateStruct': {'date': '2013-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cognitive-electrophysiological recordings', 'timeFrame': '2 hours', 'description': '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).'}, {'measure': 'Emotional and functional difficulties trait scores', 'timeFrame': '2 weeks', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Genotype data from buccal swab samples', 'timeFrame': '4 hours', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Attention deficit hyperactivity disorder', 'ADHD', 'Bipolar Disorder', 'Electrophysiological', 'EEG', 'ERP', 'Attention', 'Motivation', 'Mood instability'], 'conditions': ['Attention Deficit Hyperactivity Disorder', 'ADHD', 'Bipolar Disorder']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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)."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '25 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study population will be recruited through primary care clinics and existing research participant databases.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* current clinical diagnosis of adult ADHD\n* or current clinical diagnosis of Bipolar Disorder\n* or no history of psychiatric illness\n* white European descent\n\nExclusion Criteria:\n\n* presence of a neurodevelopmental disorder\n* epilepsy\n* brain injury\n* dyslexia\n* limited proficiency in English language\n* IQ\\<70\n* any current psychiatric medication use (with the exception of mood stabilisers or stimulant medication in the clinical groups)'}, 'identificationModule': {'nctId': 'NCT01395160', 'acronym': 'FEBA', 'briefTitle': 'Female Experiences and Brain Activity', 'organization': {'class': 'OTHER', 'fullName': "King's College London"}, 'officialTitle': 'Female Experiences and Brain Activity: an EEG Investigation Across Psychiatric Disorders', 'orgStudyIdInfo': {'id': '11/LO/0438'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adult ADHD'}, {'label': 'Bipolar Disorder'}, {'label': 'Healthy control'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BR3 3BX', 'city': 'London', 'state': 'London', 'country': 'United Kingdom', 'facility': 'South London and Maudsley NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SE5 8AF', 'city': 'London', 'state': 'London', 'country': 'United Kingdom', 'facility': "Institute of Psychiatry, King's College London", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Philip Asherson, MRCPsych, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "King's College London"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "King's College London", 'class': 'OTHER'}, 'collaborators': [{'name': 'South London and Maudsley NHS Foundation Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Project Coordinator', 'investigatorFullName': 'Glenn Mould', 'investigatorAffiliation': "King's College London"}}}}