An observational study in Treatment Resistant Depression, sponsored by LivaNova. Terminated at 33 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-20.
Sponsored by LivaNova · Observational
The objective of this study is to collect both active and passive data using a wearable, multi-sensor device (Verily Study Watch) and phone application (Mood App) which aims to capture mental health status, in subjects participating in the RECOVER clinical trial (A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression).
A prospective, observational, exploratory study collecting passive and active behavioral, environmental and physiological data, via the use of an Android smartphone application and Study Watch.
This sub-study is only open to sites participating in the RECOVER clinical study.
All subjects participating in the RECOVER clinical trial at active UNCOVER sites will be offered participation in this sub-study.
Subjects who opt-in to the Mood App portion of the sub-study will be followed for a minimum of 12 months and a maximum of 60 months for the Mood App portion of the sub-study.
Subjects who opt-in to the use of the Study Watch portion of the sub-study will be followed for a minimum of 12 months and maximum of 24 months for the Study Watch portion of the sub-study.
448 studies on the registry are indexed under Depressive Disorder, Treatment-Resistant; 147 are open to participants now.
This study's enrollment of 138 is above the median of 80 across 49 observational studies indexed under Depressive Disorder, Treatment-Resistant.
Browse Depressive Disorder, Treatment-Resistant studies →LivaNova is the lead sponsor of 40 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
This sub-study is only open to sites participating in the RECOVER clinical study.
All subjects participating in the RECOVER clinical trial at active UNCOVER sites will be offered participation in this sub-study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
All Subjects
Phone Application
Study Watch
Exclusion Criteria:
All Subjects
Phone Application
No additional exclusion criteria for phone application
Study Watch
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Percentage of PHQ-8 tasks
Percentage of PHQ-8 tasks completed over the duration of the study
Time frame: Through study completion; Average 2 years
Percentage of Voice Diary tasks
Percentage of Voice Diary tasks completed over the duration of the study
Time frame: Through study completion; Average 2 years
Number of ping sensor recordings
Number of ping sensor recordings over the duration of the study
Time frame: Through study completion; Average 2 years
Number of hours of watch wear time
Number of hours of watch wear time over the duration of the study
Time frame: Through study completion; Average 2 years
This study is terminated, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Depressive Disorder, Treatment-Resistant →