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NCT02742064 Clinical Trial

Quantified Mobile Sensing for Improving Diagnosis and Measuring Disease Progression

Depression Clinical Trial

Official title:
Quantified Mobile Sensing for Improving Diagnosis and Measuring Disease Progression

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02742064
Other study ID # 1R44MH107065-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2015
Est. completion date March 31, 2018

Study information
Verified date July 2018
Source Cogito Health Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to determine if a mobile sensing platform can passively and objectively detect the presence of clinically significant mood disorder symptomatology and symptom progression over time. Meeting this goal will allow for improved risk categorization, prediction of relapse, and measurement of disease progression in a lifetime prevalence population.

Recruitment information / eligibility
Status Completed
Enrollment 899
Est. completion date March 31, 2018
Est. primary completion date December 31, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age 18 or older

- Have a smartphone and cell service plan, including voice and data, that meets the device requirements of the Mobile Sensing Platform.

- Enrolled in the MoodNetwork

Exclusion Criteria:

- Report positively on the QIDS-SR suicide item during study intake

- Total score greater than 15 on the QIDS-SR during the screening process

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Cogito Companion Mobile Phone Application

Locations
Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (3)
Lead Sponsor Collaborator
Cogito Health Inc Massachusetts General Hospital, Partners HealthCare

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Severity of MDD symptoms as assessed by QIDS SR 6 months
Primary Severity of Mania symptoms as assessed by ASRM 6 months
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