Major Depressive Disorder Clinical Trial
Official title:
Testing the Value of Smartphone Assessments of People With Mood Disorders: A Pilot, Exploratory, Longitudinal Study
NCT number | NCT03429361 |
Other study ID # | 17-01 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 8, 2017 |
Est. completion date | May 30, 2019 |
Verified date | August 2019 |
Source | Mindstrong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this study is two-fold:
1. To identify the best smartphone data features (based on keyboard, sensor, voice/speech
data) that correlate with mood, anxiety, and cognitive assessments in patients with
Major Depressive Disorder (MDD) and Bipolar Depression (BD).
2. To identify the best smartphone data features (based on keyboard, sensor, voice/speech
at a) that predict relapse and remission in MDD or BD.
Status | Completed |
Enrollment | 23 |
Est. completion date | May 30, 2019 |
Est. primary completion date | May 30, 2019 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Adult male or female aged 18 to 65 years (inclusive) at time of informed consent - Diagnosis of Major Depression Disorder (MDD) or Bipolar Disorder (BD) as assessed using the Structured Clinical Interview for DSM Disorders-Clinical Trials (SCID-CT) - Montgomery-Asberg Depression Rating Scale (MADRS) = 26; Patient Health Questionnaire (PHQ-9) = 15; Clinical Global Impression (CGI) = 4 at screening - Ownership of a personal smartphone and willingness to install and maintain the Mindstrong app for digital assessments throughout participation in the study - Able to understand and comply with instructions in English - Has a significant other who accompanies participant to treatment appointments and agrees to complete assessments - Undergoing ketamine treatment at the Kadima Clinic, or determined by the Kadima Clinic to be eligible for ketamine treatment and agrees to receive such treatment prior to being asked to participate in this research Exclusion Criteria: - Female who is currently pregnant or planning a pregnancy within 6 months - Has any other current Axis I DSM-5 disorder other than MDD or BD, which is the primary focus of treatment - Has any other clinically significant medical condition or circumstance that, in the opinion of the Investigator, could affect patient safety, preclude evaluation of response, interfere with the ability to comply with study procedures, or prohibit completion of the study - Has a visual or physical motor impairment that could interfere with study tasks - Is site personnel directly affiliated with this study |
Country | Name | City | State |
---|---|---|---|
United States | Kadima Neuropsychiatry Institute | La Jolla | California |
Lead Sponsor | Collaborator |
---|---|
Mindstrong | Kadima Neuropsychiatry Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hamilton Depression Rating Scale (HAM-D) | A repeated measures, within-subject design using exploratory techniques will identify the best smartphone usage features or combination of features that correlate with or predict change on the HAM-D at post-treatment and follow-up. | 6 months | |
Primary | Cognitive Battery | Cognitive Battery includes: Self-report emotional referent task, face-morph task, dot-probe task, choice reaction time, forward digit span, Trails A&B, digit-symbol substitution test, delayed memory recall, Stroop, Conners Continuous Performance Test, 2-Back test. A repeated measures, within-subject design using exploratory techniques will identify the best smartphone usage features or combination of features that correlate with or predict change on the Cognitive Battery at post-treatment and follow-up. |
6 months | |
Primary | Hamilton Anxiety Rating Scale (HAM-A) | A repeated measures, within-subject design using exploratory techniques will identify the best smartphone usage features or combination of features that correlate with or predict change on the HAM-A at post-treatment and follow-up. | 6 months | |
Primary | Patient Health Questionnaire (PHQ-9) | A repeated measures, within-subject design using exploratory techniques will identify the best smartphone usage features or combination of features that correlate with or predict relapse, defined as PHQ-9 > 20 and/or 67% reduction in PHQ-9 improvement between baseline and post-treatment or follow-up, at post-treatment and follow-up. | 6 months |
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