Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-03-06 @ 6:24 PM
Study NCT ID:
NCT02804867
Status:
COMPLETED
Last Update Posted:
2017-02-23
First Post:
2016-06-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spot Depression Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D003866', 'term': 'Depressive Disorder'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-19', 'studyFirstSubmitDate': '2016-06-07', 'studyFirstSubmitQcDate': '2016-06-14', 'lastUpdatePostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of protein concentrations in dried blood spots between patient groups and controls', 'timeFrame': 'Baseline (at enrollment); no follow-up'}, {'measure': 'Assessment of classification accuracy of protein concentrations in dried blood spots for distinguishing between bipolar disorder and depression', 'timeFrame': 'Baseline (at enrollment); no follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Bipolar Disorder', 'Depressive Disorder']}, 'descriptionModule': {'briefSummary': 'This study aims to identify signs of depression and bipolar disorder by measuring changes of certain molecules (biomarkers) that can be detected in dried blood spots. Our goal is to use these biomarkers to develop a diagnostic test to enable early treatment, which can lead to better patient outcomes.', 'detailedDescription': "Bipolar disorder and major depression are serious mental health conditions that have a devastating impact on patients, their families and friends, and society. Currently, no laboratory test exists for these disorders. We are trying to develop a molecular test based on blood spots (small spots of blood obtained from patients' fingertips that have been dried on special paper). Volunteers take part by filling out the questionnaire at www.spot-depression.org. They may then be selected to provide a dried blood spot, which can be collected at home using a kit that will be mailed to their address."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants recruited using flyers, emails, and online recruitment.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Residing in the United Kingdom\n* Over 18 years of age\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* Presence of blood-borne infection'}, 'identificationModule': {'nctId': 'NCT02804867', 'briefTitle': 'Spot Depression Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Cambridge'}, 'officialTitle': 'A Blood Test to Identify Persons at Risk of Developing Depression or Bipolar Disorder', 'orgStudyIdInfo': {'id': 'HBREC.2015.06'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Depression', 'interventionNames': ['Procedure: Online questionnaire and self-administered blood spot']}, {'label': 'Bipolar disorder', 'interventionNames': ['Procedure: Online questionnaire and self-administered blood spot']}, {'label': 'Control', 'interventionNames': ['Procedure: Online questionnaire and self-administered blood spot']}], 'interventions': [{'name': 'Online questionnaire and self-administered blood spot', 'type': 'PROCEDURE', 'armGroupLabels': ['Bipolar disorder', 'Control', 'Depression']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CB2 1QT', 'city': 'Cambridge', 'state': 'Cambridgeshire', 'country': 'United Kingdom', 'facility': 'Jordan Ramsey', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}], 'overallOfficials': [{'name': 'Sabine Bahn, MD/PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Principal Investigator'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cambridge', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Postdoctoral researcher', 'investigatorFullName': 'Jordan Ramsey', 'investigatorAffiliation': 'University of Cambridge'}}}}