DepressionNCT02742064
Quantified Mobile Sensing for Improving Diagnosis and Measuring Disease Progression
An observational study of Depression and Bipolar Disorder, run by Cogito Health Inc at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Bipolar Disorder
- What is being tested?
- Cogito Companion Mobile Phone Application
- How many people
- 899 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to 31 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be selected from the MoodNetwork, an online network of individuals with mood disorders, which is hosted by MGH. A subset of participants with mood disorders enrolled in MoodNetwork will download Cogito's mobile sensing platform on their mobile phones.
Who may be able to join
- 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
Who cannot join
- Report positively on the QIDS-SR suicide item during study intake
- Total score greater than 15 on the QIDS-SR during the screening process
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
- Conditions
- Depression, Bipolar Disorder
- Being tested
- Cogito Companion Mobile Phone Application
- Medical subject headings
- Depression, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cogito Companion Mobile Phone ApplicationOther
Also called Cogito Mobile Sensing Platform
| Study group | Role | What they receive |
|---|---|---|
| MDD-Single Episode | 1. Subjects who have experienced 1 episode of major depressive disorder (MDD) in their lifetime. Receives: Other: Cogito Companion Mobile Phone Application | |
| MDD-Recurrent | 1. Subjects who have experienced 2 or more episodes of depressive disorder (MDD) in their lifetime. Receives: Other: Cogito Companion Mobile Phone Application | |
| Bipolar Disorder | 1. Subjects who have been diagnosed with bipolar disorder in their lifetime. Receives: Other: Cogito Companion Mobile Phone Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of MDD symptoms as assessed by QIDS SR
Measured: 6 months
Severity of Mania symptoms as assessed by ASRM
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2016 (estimated)
- Study startFeb 2015
- Primary completion31 Dec 2017
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 899 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cogito Health Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Massachusetts General Hospital, Partners HealthCare
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02742064
- Sponsor's protocol ID
- 1R44MH107065-01
- Status last verified
- Jul 2018
- First submitted
- 11 Apr 2016
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantified Mobile Sensing for Improving Diagnosis and Measuring Disease Progression
- ClinicalTrials.gov ID
- NCT02742064
- Acronym / sponsor ID
- 1R44MH107065-01
- Conditions
- Depression, Bipolar Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 899 participants (actual)
- Lead sponsor
- Cogito Health IncIndustry (pharma, biotech, devices)
- Collaborators
- Massachusetts General Hospital, Partners HealthCare
- Study start
- Feb 2015
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 18 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MDD-Single Episode | – | Other: Cogito Companion Mobile Phone Application1. Subjects who have experienced 1 episode of major depressive disorder (MDD) in their lifetime. |
| MDD-Recurrent | – | Other: Cogito Companion Mobile Phone Application1. Subjects who have experienced 2 or more episodes of depressive disorder (MDD) in their lifetime. |
| Bipolar Disorder | – | Other: Cogito Companion Mobile Phone Application1. Subjects who have been diagnosed with bipolar disorder in their lifetime. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be selected from the MoodNetwork, an online network of individuals with mood disorders, which is hosted by MGH. A subset of participants with mood disorders enrolled in MoodNetwork will download Cogito's mobile sensing platform on their mobile phones.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Report positively on the QIDS-SR suicide item during study intake
- Total score greater than 15 on the QIDS-SR during the screening process
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cogito Companion Mobile Phone ApplicationAlso: Cogito Mobile Sensing Platform | Other | Bipolar Disorder, MDD-Recurrent, MDD-Single Episode |
Primary outcome
Severity of MDD symptoms as assessed by QIDS SR
Time frame: 6 months
Severity of Mania symptoms as assessed by ASRM
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Bipolar Disorder, run by Cogito Health Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of MDD symptoms as assessed by QIDS SR (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2018.