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A Closed-loop Assessment and Treatment Platform for Mood Disorders

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ClinicalTrials.gov Identifier: NCT02948036
Recruitment Status : Recruiting
First Posted : October 28, 2016
Last Update Posted : October 20, 2017
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Posit Science Corporation

Brief Summary:

Specific Aim 1: Finalize development of the closed-loop strategy in the Moodify application.

Specific Aim 2: Evaluate the acceptability and feasibility of the Moodify application with the target population to prepare for a large-scale efficacy trial.

Condition or disease Intervention/treatment
Major Depressive Disorder Other: Plasticity-based adaptive cognitive treatment

Detailed Description:

Specific Aim 1: Investigators have recently constructed a beta version of the Moodify application, comprised of the multi-modal assessment modules, several treatment modules and an initial version of the closed-loop algorithm to control treatment delivery. Utilizing the extensive experience in developing mobile assessment and treatment tools at Posit Science Corporation, the investigators will employ an iterative development process incorporating feedback from users (focus groups of patients with mood disorders), clinicians and scientists (project consultants) to achieve the following development goals: (1) Finalize Moodify's closed-loop algorithm to incorporate all assessment modules and expand the existing triage approach; (2) Expand cognitive behavioral therapy (CBT) functions within the app; and (3) Expand in-app bi-directional communication feature between the clinician and user. At the completion of Specific Aim 1, the investigators will have a mobile app suitable for evaluation in a feasibility trial (Specific Aim 2).

Specific Aim 2: The investigators will conduct a single arm, open label feasibility field trial with 25 participants that meet criteria for Major Depressive Disorder (MDD). Participants will be asked to engage with the experimental cognitive treatment and spend up to six weeks engaged in 15 hours of cognitive training as an adjunct to their standard clinical treatment. The experimental cognitive treatment will be deployed as dictated by the closed loop predictive algorithm, with all patient data continuously accessible for remote monitoring by the attending clinicians and Posit Science Corporation (PSC) clinician and Principal Investigator, Dr. Thomas Van Vleet. Participants will be re-evaluated every two weeks during treatment use, and again at the expected time of completion of training, at 6 weeks, to evaluate changes in cognitive function. Participants will then stop using their assigned program for 6 weeks, and return for a follow-up assessment to evaluate the endurance of changes in cognitive function in the absence of further program use.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Closed-loop Assessment and Treatment Platform for Mood Disorders
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mood Disorders
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Moodify Other: Plasticity-based adaptive cognitive treatment
This study employs a mobile-device delivered treatment program. Participants will be asked to use the assigned treatment program for approximately 30 minutes per session, up to seven sessions per week, over 6 weeks (30 total sessions)
Other Name: Moodify

Primary Outcome Measures :
  1. Change scores for mood and depressive symptoms using Hamilton Rating Scale of Depression (HRDS-17) [ Time Frame: At 2 weeks, 4 weeks, 6 weeks and at 12 weeks ]

Secondary Outcome Measures :
  1. Change scores for depressive symptoms using Beck Depression Scale (BDI-II) [ Time Frame: At 2 weeks, 4 weeks, 6 weeks and at 12 weeks ]
  2. Change scores for depressive symptoms using Patient Health Questionnaire (PHQ-9) [ Time Frame: At 2 weeks, 4 weeks, 6 weeks and at 12 weeks ]
  3. Change scores for depressive symptoms using Quick Inventory of Depressive Symptomatology (QIDS) [ Time Frame: At 2 weeks, 4 weeks, 6 weeks and at 12 weeks ]
  4. Change scores for mood and anxiety symptoms using Mood and Anxiety Symptom Questionnaire (MASQ) [ Time Frame: At 2 weeks, 4 weeks, 6 weeks and at 12 weeks ]
  5. Change scores for anxiety symptoms using Generalized Anxiety Disorder (GAD-7) [ Time Frame: At 2 weeks, 4 weeks, 6 weeks and at 12 weeks ]
  6. Change scores for functional health and well being using the 12-Item Short Form Health Survey (SF-12) [ Time Frame: At 2 weeks, 4 weeks, 6 weeks and at 12 weeks ]
  7. Change scores for quality of life using the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) [ Time Frame: At 2 weeks, 4 weeks, 6 weeks and at 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Participant meets Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 diagnostic criteria for Major Depressive Disorder (MDD; confirmed by Structured Clinical Interview for DSM-5 (SCID))
  2. Participants must be 18 to 60 years of age
  3. Participant with a score ≥ 17 on Baseline Hamilton Rating Scale for Depression (HRSD, 17 item)
  4. Participants taking antidepressants or engaged in psychotherapy will not be excluded; instead, their antidepressant treatment will be evaluated and entered as covariates in all statistical analyses
  5. Participant must be a fluent English speaker from the age of 12
  6. Participant must have adequate sensorimotor capacity to perform the program, including visual capacity adequate to read from a computer screen at a normal viewing distance, auditory capacity adequate to understand normal speech, and motor capacity adequate to control a computer mouse, in the judgment of the consenting clinician
  7. Participant has access to wireless Internet connectivity

Exclusion Criteria:

  1. Participants with serious, unstable and/or untreated conditions that may affect cognition, including substance abuse/dependence disorders, cardiovascular, endocrine, neurologic diseases, brain injury, recent hospitalization, ongoing chemotherapy or other cancer treatment
  2. Participants with history or current DSM-5 diagnosis of organic mental disorder, schizophrenia, schizoaffective disorder, delusion disorder, psychotic disorder not otherwise specific, bipolar disorder, substance abuse (<1 year), and/or mood congruent or mood incongruent psychotic features or disorders
  3. Participant with a history or current diagnosis of dementia and/or a scores within an abnormal range on the Mini Mental State Examination, based on age and education, at the time of screening
  4. Participant with a history of seizure disorder
  5. Participants that self-report, or have clinical or laboratory evidence of hypothyroidism
  6. Participant with a lifetime history of Electroconvulsive Therapy (ECT) or Vagus Nerve Stimulation (VNS)
  7. Participant with active suicidal ideation or behaviors
  8. Participants who shows signs of intoxication due to current substance abuse (including alcohol and/or illegal drugs) during any in person visit
  9. Participant with problems performing assessments or comprehending or following spoken instructions, or those with behaviors during screening or baseline visits that, in the judgment of the screening clinician, are likely to present significant problems for the clinicians performing assessments or those supporting participants in the in-residence setting
  10. Participant is enrolled in a concurrent clinical trial involving an investigational pharmaceutical, nutraceutical, medical device, or behavioral treatment that could affect the outcome of this study. However, participation in standard treatments (e.g., occupational therapy) or use of prescribed medications (e.g., anti-depressants) is allowable.
  11. Participant is using computer-based cognitive training programs or has used it within a month of the consent date

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02948036

Contact: Sawsan Dabit 415-230-3741 sawsan.dabit@positscience.com
Contact: Dana Frostig 415-233-7119 dana.frostig@positscience.com

United States, California
Posit Science Corporation Recruiting
San Francisco, California, United States, 94111
Contact: Sawsan Dabit, PhD    415-230-3741    sawsan.dabit@positscience.com   
Principal Investigator: Thomas Van Vleet, PhD         
Sub-Investigator: Mor Nahum, PhD         
Sponsors and Collaborators
Posit Science Corporation
National Institute of Mental Health (NIMH)

Responsible Party: Posit Science Corporation
ClinicalTrials.gov Identifier: NCT02948036     History of Changes
Other Study ID Numbers: PSC-1011-16
1R43MH111325 ( U.S. NIH Grant/Contract )
First Posted: October 28, 2016    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Pathologic Processes
Mental Disorders
Behavioral Symptoms