search
Back to results

Pharmacogenomic Decision Support With GeneSight Psychotropic to Guide the Treatment of Major Depressive Disorder

Primary Purpose

Depressive Disorder, Major, Depression, Depressive Disorder

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
GeneSight Psychotropic (GEN)
Enhanced-GeneSight Psychotropic (E-GEN)
Treatment as Usual (TAU)
Sponsored by
Assurex Health Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder, Major focused on measuring Pharmacogenomic, Pharmacogenomic Testing, Pharmacogenomics, Genetic Testing, Genetics, Major Depressive Disorder, GeneSight, Enhanced GeneSight, Psychotropic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years of age or older;
  • Suffer from a Major Depressive Episode meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria;
  • Have had an inadequate response within the current episode to at least one psychotropic treatment in GEN. Inadequate response is defined as inadequate efficacy after 6 weeks of a psychotropic treatment or discontinuation of a psychotropic treatment due to adverse events (AEs) or intolerability;
  • Have each a score on the 16-item Clinician Quick Inventory of Depressive Symptomatology (QIDS-C16) and 16-item Self-Report Quick Inventory of Depressive Symptomatology (QIDS-SR16) rating scales ≥ 11;
  • Be able to understand the requirements of the study and provide written informed consent to participate in this study;
  • Agree to abide by the study protocol and its restrictions and be able to complete all aspects of the study, including all visits and tests.

Exclusion Criteria:

  • Patients posing a serious suicidal risk and/or in need of immediate hospitalization as judged by the Investigator;
  • Patients with a diagnosis of Bipolar I or II disorder;

  • Patients with a current Axis I diagnosis of:

    • Delirium
    • Dementia
    • Amnestic and/or other cognitive disorder
    • Schizophrenia or other psychotic disorder;
  • Patients having experienced hallucinations, delusions, or any psychotic symptomatology within the current depressive episode or during prior depressive episodes;
  • Patient is currently in an inpatient facility;
  • Patients with a history of hypothyroidism unless taking a stable dose of thyroid medication and asymptomatic or euthyroid for at least 6 months;
  • Patients who meet DSM-IV-TR criteria for any significant current substance use disorder;

  • Patients with:

    • hepatic insufficiency (three times the upper limit of normal (ULN) for aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)); liver transplant recipient; cirrhosis of the liver;
    • malignancy (except basal cell carcinoma) and/or chemotherapy within 1 year prior to screening; malignancy more than 1 year prior to screening must have been local and without metastasis and/or recurrence, and if treated with chemotherapy, without nervous system complications;
    • significant unstable medical condition or life threatening disease with - need for therapies that may obscure the results of treatment and/or of the study;
  • Participation in another clinical trial within 30 days of the screening visit;
  • Anticipated inability to attend scheduled study visits;
  • Patients who in the judgment of the Investigator may be unreliable or uncooperative with the evaluation procedure outlined in this protocol;
  • Patients with a history of prior pharmacogenomic testing;
  • Any change in psychotropic medication (including change in dosage) between screening and baseline;
  • Patients currently receiving electroconvulsive therapy (ECT), deep brain stimulation (DBS) or transcranial magnetic stimulation (TMS) treatments, or currently scheduled to receive maintenance treatments of ECT, DBS, or TMS during the course of the study;
  • Patients who self-report to be pregnant or lactating;
  • Patients with a history of gastric bypass surgery.

Sites / Locations

  • Chatham-Kent Clinical Trials Research Center
  • Hamilton Community Health Centre Family Health Organization
  • Hamilton Medical Research Group
  • St. Joseph's Healthcare Hamilton (SJHH)
  • Milestone Research
  • London Health Sciences Centre
  • Parkwood Institute, London
  • Hopital Montfort
  • Thornhill Medical Centre
  • Canadian Phase Onward Inc.
  • Women's College Hospital
  • Sinai Health System
  • Centre for Addiction and Mental Health (CAMH)
  • Manna Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

GeneSight Psychotropic (GEN)

Enhanced-GeneSight Psychotropic (E-GEN)

Treatment as Usual (TAU)

Arm Description

The GeneSight Psychotropic (GEN) product is a pharmacogenomic decision support tool that helps clinicians to make informed, evidence-based decisions about proper drug selection. More specifically, patients are tested for clinically important genetic variants of multiple pharmacokinetic and pharmacodynamic genes that affect a patient's ability to metabolize, tolerate or respond to medications.

The current GEN test lacks predictive genes for antipsychotic-induced weight gain (AIWG), a major complication of antipsychotic drug use. Therefore, the Enhanced-GeneSight Psychotropic (E-GEN), which is an enhanced version of the GEN test, was developed by incorporating 6 new genes (represented by 7 SNPs) that are predictive for AIWG, to those used in the GEN algorithm. An increasing risk level associated with AIWG is estimated by an increasing number of risk genotypes that a given patient possesses among the 7 SNPs.

The comparator chosen for this study provides a "real world" comparison of standard of care for patients who receive no pharmacogenomics guidance. Patients randomized to the TAU arm will also have their DNA collected and a pharmacogenomic-based interpretive report will be generated using GEN testing. However, this report will not be shared with the treating clinicians until completion at 12 months of the study. Therefore, patients in this arm will receive clinical treatment as usual, without the use or knowledge of genotyping results by their treating clinicians.

Outcomes

Primary Outcome Measures

Change in depressive symptoms as assessed by the 17-item Hamilton Depression (HAM-D17) score
Mean change in the 17-item Hamilton Depression (HAM-D17) score from baseline to Week 8 of the study

Secondary Outcome Measures

Change in depressive symptoms as assessed by the 16-Item Clinician Quick Inventory of Depressive Symptomatology (QIDS-SR16)
Change in depressive symptoms as assessed by the 9-Item Patient Health Questionnaire (PHQ-9)
Change in anxiety symptoms as assessed by theGeneralized Anxiety Disorder 7-Item (GAD-7) Scale
Change in severity of illness as assessed by the Clinical Global Impression of Severity (CGI-S)
Change in global improvement as assessed by the Clinical Global Impression of Improvement (CGI-I)
Change in global therapeutic benefit and global severity of side effects as assessed by the Clinical Global Impression Efficacy Index
Changes to initial prescribing based on availability of pharmacogenomic data
Response rates to psychotropic medication
A responder is defined as a participant with 50% decrease in HAM-D17 score from baseline.
Remission rates
A remitter is defined as a participant with HAM-D17 score equal or less that 7.
Time to response
Time to remission
Change in psychotropic medication side effects as assessed by the Udvalg for Kliniske Undersogeler (UKU) Side Effect Rating Scale
Change in global measure of side effects (frequency, intensity, and burden domains) as assessed by the Frequency, Intensity, and Burden of Side Effects Ratings (FIBSER)
Weight gain
Subject's weight
Waist-to-hip ratio
Subject's waist and hip measurements
Change in health related quality of life as assessed by the EuroQol (EQ-5D-5L)
Change in health related quality of life as assessed by the Short Form (36) Health Survey (SF-36)
Pharmacogenetics in Psychiatry Follow-up Questionnaire (PIPFQ)
The PIPFQ is a questionnaire developed by CAMH to evaluate each physician's attitude and experience to pharmacogenomic testing. Information is solicited from the physician on three different domains: the processing of the physician's last referral, the contact and outcome of the physician's patient, and the physician's perspective on the future of genetic studies in psychiatric drug treatment.
Healthcare resource utilization (Composite measure of healthcare costs): physician visits, hospital utilization, emergency department visits, medication use, and laboratory tests
Productivity losses (measured as economic costs)

Full Information

First Posted
June 3, 2015
Last Updated
April 28, 2020
Sponsor
Assurex Health Inc.
Collaborators
Programs for Assessment of Technology in Health Research Institute, Centre for Addiction and Mental Health, Genome Canada, Assurex Health Ltd., Mars Excellence in Clinical Innovation and Technology Evaluation
search

1. Study Identification

Unique Protocol Identification Number
NCT02466477
Brief Title
Pharmacogenomic Decision Support With GeneSight Psychotropic to Guide the Treatment of Major Depressive Disorder
Official Title
A Three-arm, Parallel Group, Multicentre, Double-blind, Randomized Controlled Trial Evaluating the Impact of GeneSight Psychotropic and Enhanced-GeneSight Psychotropic, on Response to Psychotropic Treatment in Outpatients Suffering From a Major Depressive Disorder (MDD) and Having Had - Within the Current Episode - an Inadequate Response to at Least One Psychotropic Medication Included in GeneSight Psychotropic
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
November 2018 (Actual)
Study Completion Date
September 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assurex Health Inc.
Collaborators
Programs for Assessment of Technology in Health Research Institute, Centre for Addiction and Mental Health, Genome Canada, Assurex Health Ltd., Mars Excellence in Clinical Innovation and Technology Evaluation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Evidence exists supporting the ability of genetic variations to influence patient drug response and side effects. Previous studies utilizing an open-label design have shown significant improvement in major depressive disorder (MDD) patient outcomes following use of the GeneSight Psychotropic (GEN) test. The first objective of this trial is to utilize a double-blinded, randomized clinical trial design to replicate previous findings of improvement in clinical outcomes in MDD subjects whose medication therapy was guided by GEN testing. Another objective is to determine the added benefit of Enhanced-GeneSight (E-GEN) compared to GEN for the pharmacogenomic guidance of treatment selections. Furthermore, this trial intends to develop an evidence-based case for the value of GEN and E-GEN to Canadian healthcare payers.
Detailed Description
The primary objectives of this study are 1) to compare the efficacy of GEN to treatment as usual (TAU) in improving response to psychotropic treatment in outpatients suffering from a MDD and having had - within the current episode - an inadequate response to at least one psychotropic medication included in GEN; and 2) to validate the utility of the new CAMH markers and demonstrate the superior predictive capabilities and greater clinical utility of E-GEN as compared to GEN. This study is designed as a three-arm multi-centre, double-blind (participants and raters), randomized controlled trial to compare the clinical and economic outcomes of GEN, E-GEN and TAU for patients suffering from a MDD and having had - within the current episode - an inadequate response to at least one psychotropic medication included in GEN. Participants will be randomized in a 1:1:1 ratio to each of the three treatment arms. Recruitment will be 24 months. Follow-up will be 12 months. Subjects will complete short diagnostic interviews specific to their clinical diagnosis, basic metabolic measures (eg. blood pressure, weight), and provide buccal swab samples for genetic analysis (the unanalyzed buccal swabs and associated DNA will be biobanked). During the first visit, blood and urine samples will be required for laboratory panel screening and blood biobanking. Subjects will be monitored over a one year period and clinical measures and healthcare resource utilization will be obtained. Treating clinicians in the GEN and E-GEN arms will receive an easy to implement report providing pharmacogenomic guidance for prescribing psychotropic medications to their patients. The study will recruit subjects from 10 sites, stratified into 2 clusters. Nine study sites altogether will form one of the two stratified clusters. CAMH will constitute the tenth study site and the second stratified cluster.The sample size required for this study was calculated using effect size estimates drawn from a previous study conducted by Hall-Flavin et al [Pharmacogenetics Genomics 2013; 23(10)]. Assuming an effect size of 0.30 in HAM-D17 score favoring the treatment group, intra class coefficient between clusters of 20%, statistical power of 90%, an alpha level of 0.05, and an expected 16.7% rate of premature discontinuation by Week 8 (primary endpoint), a total of 570 subjects (i.e., 190 per treatment arm) are required to detect the same effect in this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major, Depression, Depressive Disorder
Keywords
Pharmacogenomic, Pharmacogenomic Testing, Pharmacogenomics, Genetic Testing, Genetics, Major Depressive Disorder, GeneSight, Enhanced GeneSight, Psychotropic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
542 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GeneSight Psychotropic (GEN)
Arm Type
Experimental
Arm Description
The GeneSight Psychotropic (GEN) product is a pharmacogenomic decision support tool that helps clinicians to make informed, evidence-based decisions about proper drug selection. More specifically, patients are tested for clinically important genetic variants of multiple pharmacokinetic and pharmacodynamic genes that affect a patient's ability to metabolize, tolerate or respond to medications.
Arm Title
Enhanced-GeneSight Psychotropic (E-GEN)
Arm Type
Experimental
Arm Description
The current GEN test lacks predictive genes for antipsychotic-induced weight gain (AIWG), a major complication of antipsychotic drug use. Therefore, the Enhanced-GeneSight Psychotropic (E-GEN), which is an enhanced version of the GEN test, was developed by incorporating 6 new genes (represented by 7 SNPs) that are predictive for AIWG, to those used in the GEN algorithm. An increasing risk level associated with AIWG is estimated by an increasing number of risk genotypes that a given patient possesses among the 7 SNPs.
Arm Title
Treatment as Usual (TAU)
Arm Type
Active Comparator
Arm Description
The comparator chosen for this study provides a "real world" comparison of standard of care for patients who receive no pharmacogenomics guidance. Patients randomized to the TAU arm will also have their DNA collected and a pharmacogenomic-based interpretive report will be generated using GEN testing. However, this report will not be shared with the treating clinicians until completion at 12 months of the study. Therefore, patients in this arm will receive clinical treatment as usual, without the use or knowledge of genotyping results by their treating clinicians.
Intervention Type
Genetic
Intervention Name(s)
GeneSight Psychotropic (GEN)
Intervention Description
Patient DNA will be collected for all subjects and measured for variations in drug target genes and in drug metabolizing genes.Recommendations for optimal choices and dose adjustments for the 33 most commonly prescribed antidepressant and antipsychotic medications will be provided to subjects randomized to the GEN arm. This pharmacogenomic-based interpretive report will be provided to treating clinicians of patients in the GEN arm of the study, allowing clinicians to use the report to support their treatment decisions.
Intervention Type
Genetic
Intervention Name(s)
Enhanced-GeneSight Psychotropic (E-GEN)
Intervention Description
The E-GEN test incorporates into the existing GEN product new markers that are predictive of side effect of antipsychotic-induced weight gain (AIWG). The pharmacogenomic-based interpretive report from E-GEN will be provided to treating clinicians of patients in the E-GEN arm of the study, allowing clinicians to use the report to support their treatment decisions.
Intervention Type
Other
Intervention Name(s)
Treatment as Usual (TAU)
Intervention Description
Subjects randomized to the TAU arm will also require collection of patient DNA. A pharmacogenomic-based interpretive report will be generated from GEN, however, this report is not provided to the treating clinician until completion of the study.
Primary Outcome Measure Information:
Title
Change in depressive symptoms as assessed by the 17-item Hamilton Depression (HAM-D17) score
Description
Mean change in the 17-item Hamilton Depression (HAM-D17) score from baseline to Week 8 of the study
Time Frame
From baseline to Week 8
Secondary Outcome Measure Information:
Title
Change in depressive symptoms as assessed by the 16-Item Clinician Quick Inventory of Depressive Symptomatology (QIDS-SR16)
Time Frame
Baseline, Weeks 8 and 12, and Month 12
Title
Change in depressive symptoms as assessed by the 9-Item Patient Health Questionnaire (PHQ-9)
Time Frame
Baseline, Weeks 8 and 12, and Month 12
Title
Change in anxiety symptoms as assessed by theGeneralized Anxiety Disorder 7-Item (GAD-7) Scale
Time Frame
Baseline, Weeks 8 and 12, and Month 12
Title
Change in severity of illness as assessed by the Clinical Global Impression of Severity (CGI-S)
Time Frame
Baseline, Week 12 and Month 12
Title
Change in global improvement as assessed by the Clinical Global Impression of Improvement (CGI-I)
Time Frame
Week 12, and Month 12
Title
Change in global therapeutic benefit and global severity of side effects as assessed by the Clinical Global Impression Efficacy Index
Time Frame
Week 12 and Month 12
Title
Changes to initial prescribing based on availability of pharmacogenomic data
Time Frame
Screening and Baseline
Title
Response rates to psychotropic medication
Description
A responder is defined as a participant with 50% decrease in HAM-D17 score from baseline.
Time Frame
Baseline, Weeks 8 and 12, Months 6, 9 and 12
Title
Remission rates
Description
A remitter is defined as a participant with HAM-D17 score equal or less that 7.
Time Frame
Baseline, Weeks 8 and 12, Months 6, 9 and 12
Title
Time to response
Time Frame
Baseline, Weeks 8 and 12, Months 6, 9 and 12
Title
Time to remission
Time Frame
Baseline, Weeks 8 and 12, Months 6, 9 and 12
Title
Change in psychotropic medication side effects as assessed by the Udvalg for Kliniske Undersogeler (UKU) Side Effect Rating Scale
Time Frame
Baseline, Weeks 8 and 12, and Month 12
Title
Change in global measure of side effects (frequency, intensity, and burden domains) as assessed by the Frequency, Intensity, and Burden of Side Effects Ratings (FIBSER)
Time Frame
Baseline, Weeks 8 and 12, and Month 12
Title
Weight gain
Description
Subject's weight
Time Frame
Baseline, Weeks 8 and 12, and Month 12
Title
Waist-to-hip ratio
Description
Subject's waist and hip measurements
Time Frame
Baseline, Weeks 8 and 12, and Month 12
Title
Change in health related quality of life as assessed by the EuroQol (EQ-5D-5L)
Time Frame
Baseline, Week 12, Months 6, 9 and 12
Title
Change in health related quality of life as assessed by the Short Form (36) Health Survey (SF-36)
Time Frame
Baseline, Week 12, Months 6, 9 and 12
Title
Pharmacogenetics in Psychiatry Follow-up Questionnaire (PIPFQ)
Description
The PIPFQ is a questionnaire developed by CAMH to evaluate each physician's attitude and experience to pharmacogenomic testing. Information is solicited from the physician on three different domains: the processing of the physician's last referral, the contact and outcome of the physician's patient, and the physician's perspective on the future of genetic studies in psychiatric drug treatment.
Time Frame
Baseline, when prescription changes are made (expected average of every 4 weeks), and Month 12
Title
Healthcare resource utilization (Composite measure of healthcare costs): physician visits, hospital utilization, emergency department visits, medication use, and laboratory tests
Time Frame
Baseline, Weeks 8 and 12, Months 6, 9 and 12
Title
Productivity losses (measured as economic costs)
Time Frame
Baseline, Weeks 8 and 12, Months 6, 9 and 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years of age or older; Suffer from a Major Depressive Episode meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria; Have had an inadequate response within the current episode to at least one psychotropic treatment in GEN. Inadequate response is defined as inadequate efficacy after 6 weeks of a psychotropic treatment or discontinuation of a psychotropic treatment due to adverse events (AEs) or intolerability; Have each a score on the 16-item Clinician Quick Inventory of Depressive Symptomatology (QIDS-C16) and 16-item Self-Report Quick Inventory of Depressive Symptomatology (QIDS-SR16) rating scales ≥ 11; Be able to understand the requirements of the study and provide written informed consent to participate in this study; Agree to abide by the study protocol and its restrictions and be able to complete all aspects of the study, including all visits and tests. Exclusion Criteria: Patients posing a serious suicidal risk and/or in need of immediate hospitalization as judged by the Investigator; Patients with a diagnosis of Bipolar I or II disorder; Patients with a current Axis I diagnosis of: Delirium Dementia Amnestic and/or other cognitive disorder Schizophrenia or other psychotic disorder; Patients having experienced hallucinations, delusions, or any psychotic symptomatology within the current depressive episode or during prior depressive episodes; Patient is currently in an inpatient facility; Patients with a history of hypothyroidism unless taking a stable dose of thyroid medication and asymptomatic or euthyroid for at least 6 months; Patients who meet DSM-IV-TR criteria for any significant current substance use disorder; Patients with: hepatic insufficiency (three times the upper limit of normal (ULN) for aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)); liver transplant recipient; cirrhosis of the liver; malignancy (except basal cell carcinoma) and/or chemotherapy within 1 year prior to screening; malignancy more than 1 year prior to screening must have been local and without metastasis and/or recurrence, and if treated with chemotherapy, without nervous system complications; significant unstable medical condition or life threatening disease with - need for therapies that may obscure the results of treatment and/or of the study; Participation in another clinical trial within 30 days of the screening visit; Anticipated inability to attend scheduled study visits; Patients who in the judgment of the Investigator may be unreliable or uncooperative with the evaluation procedure outlined in this protocol; Patients with a history of prior pharmacogenomic testing; Any change in psychotropic medication (including change in dosage) between screening and baseline; Patients currently receiving electroconvulsive therapy (ECT), deep brain stimulation (DBS) or transcranial magnetic stimulation (TMS) treatments, or currently scheduled to receive maintenance treatments of ECT, DBS, or TMS during the course of the study; Patients who self-report to be pregnant or lactating; Patients with a history of gastric bypass surgery.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James L Kennedy, MD
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bryan Dechairo, PhD
Organizational Affiliation
Assurex Health Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chatham-Kent Clinical Trials Research Center
City
Chatham
State/Province
Ontario
ZIP/Postal Code
N7L 1B7
Country
Canada
Facility Name
Hamilton Community Health Centre Family Health Organization
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 5G8
Country
Canada
Facility Name
Hamilton Medical Research Group
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8M 1K7
Country
Canada
Facility Name
St. Joseph's Healthcare Hamilton (SJHH)
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3K7
Country
Canada
Facility Name
Milestone Research
City
London
State/Province
Ontario
ZIP/Postal Code
N5W6A2
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
Parkwood Institute, London
City
London
State/Province
Ontario
ZIP/Postal Code
N6C 0A7
Country
Canada
Facility Name
Hopital Montfort
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1K0T2
Country
Canada
Facility Name
Thornhill Medical Centre
City
Thornhill
State/Province
Ontario
ZIP/Postal Code
L4J 1E9
Country
Canada
Facility Name
Canadian Phase Onward Inc.
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3J 2C5
Country
Canada
Facility Name
Women's College Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 1B2
Country
Canada
Facility Name
Sinai Health System
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 3L9
Country
Canada
Facility Name
Centre for Addiction and Mental Health (CAMH)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6J 1H4
Country
Canada
Facility Name
Manna Research
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9W 4L6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
35288545
Citation
Tiwari AK, Zai CC, Altar CA, Tanner JA, Davies PE, Traxler P, Li J, Cogan ES, Kucera MT, Gugila A, Braganza N, Emmerson H, Zai G, Muller DJ, Levitan R, Kloiber S, Daskalakis ZJ, Frey BN, Bowen JM, Tarride JE, Tytus R, Chandrasena R, Voudouris N, Taylor VH, Tempier R, Sharma V, Vasudev A, Dzongowski P, Pliamm L, Greenspoon T, Dechairo BM, Kennedy JL. Clinical utility of combinatorial pharmacogenomic testing in depression: A Canadian patient- and rater-blinded, randomized, controlled trial. Transl Psychiatry. 2022 Mar 14;12(1):101. doi: 10.1038/s41398-022-01847-8. Erratum In: Transl Psychiatry. 2022 May 30;12(1):214.
Results Reference
derived

Learn more about this trial

Pharmacogenomic Decision Support With GeneSight Psychotropic to Guide the Treatment of Major Depressive Disorder

We'll reach out to this number within 24 hrs