Major Depressive Disorder Clinical Trial
— MHTVOfficial title:
Mental Health Telemetry for Self-Management in Major Depression
Verified date | November 2016 |
Source | Sunnybrook Health Sciences Centre |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Ethics Review Committee |
Study type | Interventional |
Mood journaling is a cornerstone of self-management in major depressive disorder (MDD).
Research over the last decade has shown that electronic mood journals are superior to paper
ones. One potential advantage of mental health telemetry (MHT), which use cell phones to
collect mood journal data, is that electronic journal data can easily be converted into
graphical records, allowing people living with MDD to readily spot trends, correlations, or
patterns in ways that would be quite challenging using paper diaries. This information
should make it easier to recognize and evaluate changes in mental health status -- the first
two steps in the process of self-management. The investigators will develop and deploy a
visualization module for patients with which to explore their own MHT data sets on the same
cell phones which they record their journals, and test the investigators hypotheses that
their enhanced MHT system will (i) improve patients' ability to self-manage MDD and (ii)
enhance their quality-of-life.
The study is a non-randomized, un-blinded, A-B-A' (modified single-subject withdrawal
design, with user choice of treatment or withdrawal in the A' stage) study, to explore the
utility of MHT as a tool for enhancing self-management and QoL for persons living with MDD.
The aims of this study are to explore the impact of MHT on subjects' self-management and
QoL, and to gauge participants' perceptions of MHT's utility.
Status | Completed |
Enrollment | 27 |
Est. completion date | April 2016 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 14 Years and older |
Eligibility |
We will recruit (n=113) patients with a Diagnostic and Statistical Manual, 4th Ed.
(DSM-IV) diagnosis of MDD, confirmed using the MDD section of the M.I.N.I. International
Neuropsychiatric Interview (MINI) version 5.0. All recruits will own or use a web-enabled
cell phone. Exclusion Criteria: - self-disclosed illiteracy; - blindness; - inability to be successfully trained in the use of MHT |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Sunnybrook Health Sciences Centre | Canadian Institutes of Health Research (CIHR) |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Retention Rates (Exploratory) | We will report the proportion and 95% confidence interval (CI) of users who opt to continue using MHT in the A' (user choice) phase | Four months | No |
Other | Utilization Rates (Exploratory) | We will report the mean number and 95% CI of times per patient (in the B and A' phases) that MHT data was (i) reported and (ii) visualized. | Six months | No |
Primary | Change in self-management ratings | Self-management ratings using the three sub-scale scores (maintenance, management, and confidence) of the Sunnybrook Self-Management Scale - Depression (3S-D) instrument at the end of the Treatment-as-Usual phase (two months) as compared to the end of the active treatment phase (four months) | two months and four months | No |
Secondary | Change in Quality-of-life (QoL) ratings | Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ) scores at the end of the treatment-as-usual (two months) and active treatment (four months) phases. We will control for severity of mood symptoms (using mental health telemetry (MHT) composite depression scores) as a covariate of the magnitude of change in QoL outcomes because we expect that some, but not all, of the variance in QoL outcomes will be accounted for in particular by the severity of depression. | two months and four months | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05537558 -
Precision Medicine for the Prediction of Treatment (PROMPT) Response (PROMPT)
|
||
Terminated |
NCT02192099 -
Open Label Extension for GLYX13-C-202, NCT01684163
|
Phase 2 | |
Completed |
NCT03142919 -
Lipopolysaccharide (LPS) Challenge in Depression
|
Phase 2 | |
Recruiting |
NCT05547035 -
Identification of Physiological Data by a Wearable Monitor in Subjects Suffering From Major Depression Disorders
|
N/A | |
Terminated |
NCT02940769 -
Neurobiological Effects of Light on MDD
|
N/A | |
Recruiting |
NCT05892744 -
Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression
|
Phase 4 | |
Recruiting |
NCT05537584 -
SMART Trial to Predict Anhedonia Response to Antidepressant Treatment
|
Phase 4 | |
Active, not recruiting |
NCT05061706 -
Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
|
Phase 3 | |
Completed |
NCT04479852 -
A Study of the Safety and Efficacy of SP-624 in the Treatment of Adults With Major Depressive Disorder
|
Phase 2 | |
Recruiting |
NCT04032301 -
Repeated Ketamine Infusions for Comorbid PTSD and MDD in Veterans
|
Phase 1 | |
Recruiting |
NCT05527951 -
Enhanced Measurement-Based Care Effectiveness for Depression (EMBED) Study
|
N/A | |
Completed |
NCT03511599 -
Cycloserine rTMS Plasticity Augmentation in Depression
|
Phase 1 | |
Recruiting |
NCT04392947 -
Treatment of Major Depressive Disorder With Bilateral Theta Burst Stimulation
|
N/A | |
Recruiting |
NCT05895747 -
5-HTP and Creatine for Depression R33 Phase
|
Phase 2 | |
Recruiting |
NCT05273996 -
Predictors of Cognitive Outcomes in Geriatric Depression
|
Phase 4 | |
Recruiting |
NCT05813093 -
Interleaved TMS-fMRI in Ultra-treatment Resistant Depression
|
N/A | |
Recruiting |
NCT05135897 -
The Neurobiological Fundaments of Depression and Its Relief Through Neurostimulation Treatments
|
||
Enrolling by invitation |
NCT04509102 -
Psychostimulant Augmentation of Repetitive TMS for the Treatment of Major Depressive Disorder
|
Early Phase 1 | |
Recruiting |
NCT06145594 -
EMA-Guided Maintenance TMS for Depression
|
N/A | |
Recruiting |
NCT06026917 -
Assessing Dopamine Transporter Occupancy in the Patients With Depression Brain With Toludesvenlafaxine Hydrochloride Extended-Release Tablets Using 11C-CFT Positron Emission Tomography (PET)
|
Phase 4 |