Quantified Mobile Sensing for Improving Diagnosis and Measuring Disease Progression

NCT ID: NCT02742064

Last Updated: 2018-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

899 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Study Completion Date

2018-03-31

Brief Summary

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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

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Conditions

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Depression Bipolar Disorder

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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MDD-Single Episode

1\. Subjects who have experienced 1 episode of major depressive disorder (MDD) in their lifetime.

Cogito Companion Mobile Phone Application

Intervention Type OTHER

MDD-Recurrent

1\. Subjects who have experienced 2 or more episodes of depressive disorder (MDD) in their lifetime.

Cogito Companion Mobile Phone Application

Intervention Type OTHER

Bipolar Disorder

1\. Subjects who have been diagnosed with bipolar disorder in their lifetime.

Cogito Companion Mobile Phone Application

Intervention Type OTHER

Interventions

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Cogito Companion Mobile Phone Application

Intervention Type OTHER

Other Intervention Names

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Cogito Mobile Sensing Platform

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role collaborator

Partners HealthCare

OTHER

Sponsor Role collaborator

Cogito Health Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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1R44MH107065-01

Identifier Type: NIH

Identifier Source: org_study_id

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