Major Depressive Disorder Clinical Trial
Official title:
Using Mental Health Telemetry to Predict Relapse and Re-hospitalization in Mood Disorders
Mood disorders -- major depression, bipolar disorder, and dysthymia -- frequently recur; they affect one in four people during their lives. At Sunnybrook, 75% of inpatient admissions are due to mood disorders. Mental health telemetry (MHT) lets patients in the community use cell phones to track the severity of their mood symptoms over time, and enables clinicians to view these symptom ratings in real-time. Evidence suggests that MHT is better for detecting exacerbations of illness earlier than standard clinical practice alone. In this study, we will assess if MHT can reduce re-hospitalization rates in previously-hospitalized patients with mood disorders.
The mood disorders (major depressive disorder, bipolar disorder, and dysthymia) are a
significant public health issue: mood disorders affect approximately one in four people
during their lives; in total, over 8 million Canadians are affected by mood disorders,
costing the economy over $6 billion annually. Mood disorders are generally recurrent:
approximately 50% of cases of major depressive disorder will relapse at least once; 15% will
run a chronic course. With bipolar disorder, a chronic course of episodes of depression
and/or mania intermixed with episodes of normal mood is typical. At Sunnybrook (SHSC), 75%
of inpatient mental health admissions are due to mood disorders. Clinically, with mood
disorders, earlier recognition of symptom changes in patients provides greater potential for
early intervention and suppression of relapses, which in turn leads to reduced outpatient
resource utilization, fewer Emergency Department visits, and fewer readmissions.
Ecological momentary assessment (EMA), a body of work developed in the late 90s and early
00's, focuses on using data collected from subjects living their daily lives in their
natural environments using minimally invasive techniques to improve the quality of the data
collected. Mental health telemetry (MHT) is an evolution of EMA. MHT was developed here at
Sunnybrook in partnership with the Faculty of Medicine at the University of Toronto; it uses
wirelessly networked handheld computers - typically, cell phones - to collect self-report
data on symptoms of illness and then transmit it in real-time to a central database.
Principal advantages of MHT over EMA include (i) the ability to time- and date-stamp data,
thus eliminating retrospective record completion, and (ii) the ability to observe and
monitor data flow in real-time, without having to wait for participants to upload or deliver
the data (e.g., at their next doctors' appointment).
MHT has been used to collect rich sets of longitudinal self-report ratings from patients
while they live their daily lives in the community; populations studied include adults with
depression, premenstrual syndrome, and bipolar disorder (for as long as 18 months), as well
as teens with mood swings (for as long as nine months). Adherence to daily (or more
frequent) symptom reporting using MHT in these studies has been very good, with adherence
rates of 75±5 % over the duration of the studies.
MHT has considerable potential to reduce rates of inpatient re-hospitalization for mood
disorders. EMA methods have previously shown to be superior to standard patient follow-ups
for detecting medication response in depression14 or days ill in bipolar disorder18. While
numerous previous studies have looked at general patterns of recurrence and prognostic
factors in the long-term course of major depressive disorder4;23;24;27 and bipolar disorder,
none have looked at using EMA or MHT data to monitor for signs of imminent relapse in
individual cases. The rich data stream provided by MHT will allow us to do this for the
first time, similar to how ECG telemetry is routinely used for diagnostic and prognostic
purposes. Doing so will enable clinicians to trigger early community- or outpatient-based
interventions, thus reducing the likelihood of relapse and / or hospitalization.
One limitation of the MHT studies to-date has been the platform-specific nature of the MHT
systems used: rather than using platform-independent software, the systems deployed to date
have been custom-created for specific cell-phone platforms (e.g., the Kyocera pdQ 1900, the
Palm Treo family of SmartPhones, or the Motorola QA30). As a result, until now, MHT has been
limited use by participants in research studies who were provided with a research-funded
cell phone.
Therefore, to explore the feasibility of using MHT to reduce re-hospitalization in patients
with diagnosed mood disorders, we will:
1. Upgrade our existing patient MHT software (for recording MHT) to a web-based platform,
thus removing all hardware dependency from MHT and allowing anyone who has a
web-capable cell phone to use MHT essentially without cost;
2. Upgrade our existing clinician PATH software (for viewing patients' MHT), optimizing
its user interface to make it easy for clinicians to rapidly and effectively visualize
their patients' telemetry;
3. Distribute clinician PATH software to interested clinicians within the SHSC Department
of Psychiatry, to enable clinicians to receive daily, patient-generated, quantitative
symptom severity ratings as well as medication adherence and side-effect reports from
their patients. (Clinicians will use this information in collaboration with their
patients to aid in monitoring patients' mental status over the course of this study.)
4. Over the duration of the study, distribute patient MHT software to a random sample of
patients with (i) a mood disorder being discharged from Sunnybrook's inpatient mental
health ward (F2) or (ii) bipolar disorder being followed in the outpatient psychiatry
clinics at Sunnybrook; then,
5. Compare re-hospitalization rates and quality-of-life measures of MHT users over a 6
month period to a control group of similar patients not using MHT.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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 |
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 | |
Recruiting |
NCT06145594 -
EMA-Guided Maintenance TMS for Depression
|
N/A |