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Center for Global Research Data

Predicting Treatment Efficacy in Individuals with Major Depression -- Deep Neural Networks for Physiological Patient Parameters

Lead Investigator: Gustavo Turecki, Douglas Mental Health University Institute
Title of Research Proposal: Predicting Treatment Efficacy in Individuals with Major Depression — Deep Neural Networks for Physiological Patient Parameters
Vivli Data Request: 4920
Funding Source: Government Funding – CIHR via Era permed
Potential Conflicts of Interest: DB, CA, RF, KP, SI are officers or shareholders in Aifred Health, the mental health AI startup collaborating with the Douglas on this project. Conflicts of interest are managed as all publications must pass through Dr. Turecki, who has no interest in the company, as must the direction of the research project. All conflicts have also been declared as part of the successful local REB application..
Summary of the Proposed Research: 

Major Depression is a serious mental illness that globally affects 11.1% of people over the course of their lives [1] and that is projected to be responsible for the majority of Disability-Adjusted Life Years (DALY’s) lost by 2030 [2,3]. While a range of effective treatments do exist, these are not equivalently effective for all patients and some patients can spend years finding the right choice from the dozens of medications, multiple psychotherapies, and five neurostimulation techniques available.

Currently, most patients and their physicians have little option but to go through a “guess and check” approach to finding the right treatment. For a patient with depression, trying a new treatment means several weeks of therapy or medication titration to start seeing if there is a positive effect. This is time lost in the patient’s life — time that is potentially away from work and when they are not able to be fully present in their families’ lives. Inadequately treated depression also leads to risks of suicide and self-harm. What’s more, many patients with depression will not improve after the first treatment — in the STAR*D trial, only about one third of patients improved after their first treatment trial, with decreasing response rates after further trials [4]. This means that the decision about which treatment to try is one that has significant consequences.

 

It is clear that a research objective for depression, other than improving diagnostic rates and access to care, should be developing an evidence-based approach for rapidly selecting the most effective treatment for a given patient, as early on in their clinical course as possible, while minimizing side effects that lead to reduced quality of life or treatment adherence. Existing psychiatric guidelines do separate the large of array of treatment options into first, second, and third line treatments [5]; and clinical experience has taught mental health professionals that certain types of medications or psychotherapy approaches work best in certain kinds of patients. Different patients develop different side effects to the same medication in an often unpredictable manner, further complicating treatment choice [5].However, there is not a systematic, evidence-based tool that predicts treatments in a way that is personalized to a given patient [5,6,7,8].

Requested Studies:

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF 2 FIXED DOSES (10 MG AND 50 MG/DAY) OF DVS SR TABLETS IN ADULT OUTPATIENTS WITH MAJOR DEPRESSIVE DISORDER.

Data Contributor: Pfizer Inc.

Study ID: NCT00863798/B2061005

A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF PRISTIQ IN FUNCTIONALLY IMPAIRED PATIENTS WITH MAJOR DEPRESSIVE DISORDER

Data Contributor: Pfizer Inc.

Study ID: NCT00824291/B2061006

A MULTICENTER, RANDOMIZED, 8-WEEK DOUBLE-BLIND ACUTE PHASE FOLLOWED BY A 6-MONTH CONTINUATION PHASE (OPEN-LABEL OR DOUBLE-BLIND) STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF DVS SR VERSUS ESCITALOPRAM IN POSTMENOPAUSAL WOMEN WITH MAJOR DEPRESSIVE DISORDER

Data Contributor: Pfizer Inc.

Study ID: NCT00406640/B2061096

AN 8-WEEK STUDY OF DVS VS. PLACEBO IN PERI- AND POST-MENOPAUSAL WOMEN (>40 YEARS)

Data Contributor: Pfizer Inc.

Study ID: NCT00369343/B2061097

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of DVS-233 SR For Prevention Of Depressive Relapse In Adult Outpatients With Major Depressive Disorder

Data Contributor: Pfizer Inc.

Study ID: NCT00075257/B2061068

A 10 MONTH OPEN-LABEL EVALUATION OF THE LONG-TERM SAFETY OF DVS-233 SR IN OUTPATIENTS WITH MAJOR DEPRESSIVE DISORDER

Data Contributor: Pfizer Inc.

Study ID: NCT01309542/B2061069

A Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study of a Flexible Dose of DVS-233 SR in Adult Outpatients With Major Depressive Disorder

Data Contributor: Pfizer Inc.

Study ID: NCT00063206/B2061070

MULTICENTER, RANDOMIZED DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THREE FIXED DOSES OF DVS-233 SR IN ADULT OUTPATIENTS WITH MAJOR DEPRESSIVE DISORDER

Data Contributor: Pfizer Inc.

Study ID: NCT00072774/B2061072

RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY OF DVS-233 SR IN INPATIENTS WITH MAJOR DEPRESSIVE DISORDER

Data Contributor: Pfizer Inc.

Study ID: NCT00073762/B2061074

MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO AND COMPARATOR CONTROLLED STUDY OF A FLEXIBLE DOSE OF DVS-233 SR IN OUTPATIENTS WITH MAJOR DEPRESSION

Data Contributor: Pfizer Inc.

Study ID: NCT00090649/B2061075

MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF A FIXED DOSE OF DVS-233 SR IN OUTPATIENTS WITH MAJOR DEPRESSION.

Data Contributor: Pfizer Inc.

Study ID: NCT00087737/B2061081

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, EFFICACY AND SAFETY STUDY OF DVS-233 SR IN OUTPATIENTS WITH MAJOR DEPRESSIVE DISORDER.

Data Contributor: Pfizer Inc.

Study ID: NCT00092911/B2061083

A 12-MONTH, OPEN-LABEL, EVALUATION OF THE LONG-TERM SAFETY OF DVS-233 SR IN OUTPATIENTS WITH MAJOR DEPRESSIVE DISORDER

Data Contributor: Pfizer Inc.

Study ID: NCT00452595/B2061082

A MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED WITHDRAWAL, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF 50 MG/DAY OF DVS SR IN ADULT OUTPATIENTS WITH MAJOR DEPRESSIVE DISORDER

Data Contributor: Pfizer Inc.

Study ID: NCT00887224/B2061004

A PHASE IV, MULTICENTER, RANDOMIZED, 8-WEEK, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY OF 2 FIXED DOSES (50 AND 100 MG/DAY) OF DESVENLAFAXINE SUCCINATE SUSTAINED-RELEASE FORMULATION (DVS SR) IN ADULT OUTPATIENTS WITH MAJOR DEPRESSIVE DISORDER

Data Contributor: Pfizer Inc.

Study ID: NCT01432457/B2061028

A MULITCENTER, PARALLEL-GROUP, RANDOMIZED, 10-WEEK, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF 50 MG OF DESVENLAFAXINE SUCCINATE SUSTAINED-RELEASE FORMULATION (DVS SR) IN THE TREATMENT OF PERI- AND POST-MENOPAUSAL WOMEN WITH MAJOR DEPRESSIVE DISORDER

Data Contributor: Pfizer Inc.

Study ID: NCT01121484/B2061029

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, FLUOXETINE-REFERENCED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF DESVENLAFAXINE SUCCINATE SUSTAINED RELEASE (DVS SR) IN THE TREATMENT OF CHILDREN AND ADOLESCENT OUTPATIENTS WITH MAJOR DEPRESSIVE DISORDER

Data Contributor: Pfizer Inc.

Study ID: NCT01372150/B2061014

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF DESVENLAFAXINE SUCCINATE SUSTAINED-RELEASE (DVS SR) IN THE TREATMENT OF CHILDREN AND ADOLESCENT OUTPATIENTS WITH MAJOR DEPRESSIVE DISORDER

Data Contributor: Pfizer Inc.

Study ID: NCT01371734/B2061032

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF TWO FIXED DOSES (25 MG AND 50 MG/DAY) OF DVS SR IN ADULT OUTPATIENTS WITH MAJOR DEPRESSIVE DISORDER

Data Contributor: Pfizer Inc.

Study ID: NCT00798707/B2061003

A 10-MONTHS OPEN-LABEL EVALUATION OF THE LONG-TERM SAFETY OF DVS-233 SR IN JAPANESE ADULTS WITH MAJOR DEPRESSIVE DISORDER

Data Contributor: Pfizer Inc.

Study ID: NCT00831415/B2061002

A 6-MONTH, OPEN-LABEL, MULTI-CENTER, FLEXIBLE DOSE EXTENSION STUDY TO THE B2061032 STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND EFFICACY OF DESVENLAFAXINE SUCCINATE SUSTAINED RELEASE (DVS SR) TABLETS IN THE TREATMENT OF CHILDREN AND ADOLESCENT OUTPATIENTS WITH MAJOR DEPRESSIVE DISORDER

Data Contributor: Pfizer Inc.

Study ID: NCT01371708/B2061030

A 6 MONTH, OPEN LABEL, MULTI CENTER, FLEXIBLE DOSE EXTENSION STUDY TO THE B2061014 STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND EFFICACY OF DESVENLAFAXINE SUCCINATE SUSTAINED RELEASE (DVS SR) TABLETS IN THE TREATMENT OF CHILDREN AND ADOLESCENT OUTPATIENTS WITH MAJOR DEPRESSIVE DISORDER

Data Contributor: Pfizer Inc.

Study ID: NCT01371721/B2061031

A RANDOMIZED, DOUBLE-BLIND PARALLEL GROUP STUDY TO COMPARE DISCONTINUATION SYMPTOMS IN ABRUPT DISCONTINUATION VERSUS A 1-WEEK TAPERING REGIMEN IN SUBJECTS WITH MAJOR DEPRESSIVE DISORDER (MDD) TREATED FOR 24 WEEKS WITH OPEN-LABEL 50 MG DESVENLAFAXINE SUCCINATE SUSTAINED-RELEASE FORMULATION (DVS SR)

Data Contributor: Pfizer Inc.

Study ID: NCT01056289/B2061010

MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDYTO EVALUATE THE EFFICACY AND SAFETY OF TWO FIXED DOSES (50 MG, 100 MG) OF DVS-233 SR IN ADULT OUTPATIENTS WITH MAJOR DEPRESSION

Data Contributor: Pfizer Inc.

Study ID: NCT00277823/B2061084

MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TOEVALUATE THE EFFICACY AND SAFETY OF TWO FIXED DOSES (50 MG, 100 MG) OFDVS-233 IN ADULT OUTPATIENTS WITH MAJOR DEPRESSION

Data Contributor: Pfizer Inc.

Study ID: NCT00300378/B2061085

STUDY OF 3 FIXED DOSES OF DVS SR IN MDD

Data Contributor: Pfizer Inc.

Study ID: NCT00384033/B2061041