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Spot Depression Study

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ClinicalTrials.gov Identifier: NCT02804867
Recruitment Status : Completed
First Posted : June 17, 2016
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Jordan Ramsey, University of Cambridge

Brief Summary:
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.

Condition or disease Intervention/treatment
Bipolar Disorder Depressive Disorder Procedure: Online questionnaire and self-administered blood spot

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: A Blood Test to Identify Persons at Risk of Developing Depression or Bipolar Disorder
Study Start Date : March 2016
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Depression Procedure: Online questionnaire and self-administered blood spot
Bipolar disorder Procedure: Online questionnaire and self-administered blood spot
Control Procedure: Online questionnaire and self-administered blood spot



Primary Outcome Measures :
  1. Comparison of protein concentrations in dried blood spots between patient groups and controls [ Time Frame: Baseline (at enrollment); no follow-up ]
  2. Assessment of classification accuracy of protein concentrations in dried blood spots for distinguishing between bipolar disorder and depression [ Time Frame: Baseline (at enrollment); no follow-up ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants recruited using flyers, emails, and online recruitment.
Criteria

Inclusion Criteria:

  • Residing in the United Kingdom
  • Over 18 years of age

Exclusion Criteria:

  • Pregnant or breastfeeding
  • Presence of blood-borne infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02804867


Locations
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United Kingdom
Jordan Ramsey
Cambridge, Cambridgeshire, United Kingdom, CB2 1QT
Sponsors and Collaborators
University of Cambridge
Investigators
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Principal Investigator: Sabine Bahn, MD/PhD Principal Investigator
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Responsible Party: Jordan Ramsey, Postdoctoral researcher, University of Cambridge
ClinicalTrials.gov Identifier: NCT02804867    
Other Study ID Numbers: HBREC.2015.06
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Disease
Depressive Disorder
Bipolar Disorder
Pathologic Processes
Mood Disorders
Mental Disorders
Bipolar and Related Disorders