Pharmacogenomic Decision Support With GeneSight Psychotropic to Guide the Treatment of Major Depressive Disorder
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
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.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Recruitment status
completed
Actual enrollment (reported)
542 participants
Study completion date
September 2019
Actual (reported)
Listed locations
1 countries · 14 sites
Trial Relationships
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Related Scientific Literature
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
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
From baseline to Week 8
Secondary Outcomes (20)
Change in depressive symptoms as assessed by the 16-Item Clinician Quick Inventory of Depressive Symptomatology (QIDS-SR16)
Baseline, Weeks 8 and 12, and Month 12
Change in depressive symptoms as assessed by the 9-Item Patient Health Questionnaire (PHQ-9)
Baseline, Weeks 8 and 12, and Month 12
Study Arms (3)
GeneSight Psychotropic (GEN)
EXPERIMENTAL
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.
Genetic: GeneSight Psychotropic (GEN)
Enhanced-GeneSight Psychotropic (E-GEN)
EXPERIMENTAL
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.
Genetic: Enhanced-GeneSight Psychotropic (E-GEN)
Interventions
GeneSight Psychotropic (GEN)Genetic
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.
GeneSight Psychotropic (GEN)
Enhanced-GeneSight Psychotropic (E-GEN)Genetic
Eligibility Criteria
Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
You may qualify if:
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;
Change in anxiety symptoms as assessed by theGeneralized Anxiety Disorder 7-Item (GAD-7) Scale
Baseline, Weeks 8 and 12, and Month 12
Change in severity of illness as assessed by the Clinical Global Impression of Severity (CGI-S)
Baseline, Week 12 and Month 12
Change in global improvement as assessed by the Clinical Global Impression of Improvement (CGI-I)
Week 12, and Month 12
+15 more secondary outcomes
Treatment as Usual (TAU)
ACTIVE COMPARATOR
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.
Other: Treatment as Usual (TAU)
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.
Enhanced-GeneSight Psychotropic (E-GEN)
Treatment as Usual (TAU)Other
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.
Treatment as Usual (TAU)
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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.
You may not qualify if:
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;
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Source: ClinicalTrials.gov.
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