Quantified Mobile Sensing for Improving Diagnosis and Measuring Disease Progression

Completed

• Conditions: Bipolar Disorder; Depression

• Registration Number: NCT02742064
• Lead Sponsor: Cogito Health Inc

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2016-04-11
• Study First Submitted QC: 2016-04-13
• Study First Posted: 2016-04-18
• Primary Completion: 2017-12-31
• Study Completion: 2018-03-31
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-16
• Last Update Posted: 2018-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 899

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Severity of Mania symptoms as assessed by ASRM	6 months
Severity of MDD symptoms as assessed by QIDS SR	6 months

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States