Status:
COMPLETED
Testing the Value of Smartphone Assessments of People With Mood Disorders
Lead Sponsor:
Mindstrong
Collaborating Sponsors:
Kadima Neuropsychiatry Institute
Conditions:
Major Depressive Disorder
Bipolar Disorder
Eligibility:
All Genders
18-65 years
Brief Summary
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 ...
Detailed Description
Progress in psychiatry will require better measurement. Currently, few clinicians use standard rating instruments for either diagnosis or outcomes. As a result, clinicians often fail to detect when a ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 8 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 30 2019
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT03429361
Start Date
August 8 2017
End Date
May 30 2019
Last Update
August 22 2019
Active Locations (1)
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1
Kadima Neuropsychiatry Institute
La Jolla, California, United States, 92037