Testing the Value of Smartphone Assessments of People With Mood Disorders

NCT03429361 | Completed

• 1 other identifier: 17-01
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is two-fold:

1. 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. 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.

Conditions

Major Depressive Disorder; Bipolar Disorder

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Interventions

Health by Mindstrong OTHER

Health by Mindstrong is a smartphone application that collects data on a participant's smartphone usage patterns.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes men and women between the ages of 18 and 65 years, with a diagnosis of Major Depressive Disorder (MDD) or Bipolar Disorder (BD), currently undergoing ketamine treatment for that disorder.

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

Sponsors & Collaborators

• Mindstrong: lead
• Kadima Neuropsychiatry Institute: collaborator

Study Sites (1)

Kadima Neuropsychiatry Institute

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Bipolar Disorder

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Bipolar and Related Disorders

Study Officials

• Paul Dagum, MD PhD

  Mindstrong

  PRINCIPAL INVESTIGATOR

• David Feifel, MD PhD

  Kadima Neuropsychiatry Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: February 12, 2018
• Study Start: August 8, 2017
• Primary Completion: May 30, 2019
• Study Completion: May 30, 2019
• Last Updated: August 22, 2019

Record last verified: 2019-08

Locations

US (1)