Testing the Value of Smartphone Assessments of People With Mood Disorders

Completed

Conditions studied: Major Depressive Disorder, Bipolar Disorder

In brief

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.

Key facts

Study ID

NCT03429361

Run by

Mindstrong

People needed

23

Starts

2017-08-08

Expected to finish

2019-05-30

Last updated by the study team

2019-08-22

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Kadima Neuropsychiatry Institute — La Jolla, California, United States

Full record on ClinicalTrials.gov

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