Spot Depression Study

Bipolar Disorder Clinical Trial

Official title:

A Blood Test to Identify Persons at Risk of Developing Depression or Bipolar Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02804867
• Other study ID #: HBREC.2015.06
• Status: Completed
• Phase: N/A
• First received: June 7, 2016
• Last updated: February 19, 2017
• Start date: March 2016
• Est. completion date: September 2016

Study information

• Verified date: February 2017
• Source: University of Cambridge
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Residing in the United Kingdom

• Over 18 years of age

Exclusion Criteria:

• Pregnant or breastfeeding

• Presence of blood-borne infection

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depressive Disorder
• Disease

Intervention

Procedure:
• Online questionnaire and self-administered blood spot

Locations

Country	Name	City	State
United Kingdom	Jordan Ramsey	Cambridge	Cambridgeshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Cambridge

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of protein concentrations in dried blood spots between patient groups and controls		Baseline (at enrollment); no follow-up
Primary	Assessment of classification accuracy of protein concentrations in dried blood spots for distinguishing between bipolar disorder and depression		Baseline (at enrollment); no follow-up