Genecept Assay™ vs. Treatment-as-Usual to Evaluate Efficacy of Assay-Guided Treatment in Adults With MDD

Sponsor
Genomind, LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT02634177
Collaborator
Medpace, Inc. (Industry)
305
23
2
18.8
13.3
0.7

Study Details

Study Description

Brief Summary

In this randomized clinical trial, subjects will be assigned to either an assay-guided treatment condition (AGT) or a treatment-as-usual condition (TAU). All subjects will provide a DNA sample at the Screening Visit for the Genecept Assay ™. In the AGT condition, assay results will be provided to the treating investigator, who will use the results to guide antidepressant pharmacotherapy. In the TAU condition, the investigator will treat the subjects without the knowledge of the pharmacogenetic testing results. Assay results for all subjects will be provided to the investigator once all Week 8 visit procedures have been completed. Raters of the primary endpoint assessment and subjects will remain blinded to treatment assignment.

Condition or Disease Intervention/Treatment Phase
  • Genetic: Assay-guided treatment (AGT)
  • Other: Treatment-as-usual (TAU)
N/A

Detailed Description

This study compares efficacy and safety outcomes in Major Depressive Disorder (MDD) adult patients randomized to assay-guided treatment (AGT) or treatment-as-usual (TAU). The treatment duration will be 8-weeks. Subjects will be assessed at visits at Week 2, 4, 6 and 8. Approximately 300 subjects will be randomized 1:1 to the two treatment group (AGT and TAU). This is a multi-center trial, with approximately 25 sites in the US. Randomization will be by IWRS. The treating investigator will be unblinded to treatment assignment (necessarily). Other site staff, sponsor staff (including site monitors) and all others will be blinded to treatment assignment for the duration of the subject's participation in the study. The (blinded) rater for the primary endpoint, the SIGH-D-17 Hamilton Depression Scale, will have no other contact with the subject such as collection of screening data, follow-up assessments, documentation of adverse events, etc. Blinded raters will not discuss subjects with other study staff.

After recruitment for main study is completed, an additional 70 subjects , age 65 years and older will be randomized to the Exploratory Elderly MDD Study. This follow-on sub-study will apply all procedures of the main study to this elderly population subset.

Study Design

Study Type:
Interventional
Actual Enrollment :
305 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
An 8-Week Prospective Randomized, Controlled, Double-Blind Trial of the Genecept Assay ™ vs. Treatment-as-Usual to Evaluate Efficacy of Assay-Guided Treatment in Adults With Major Depressive Disorder (MDD)
Study Start Date :
Jan 1, 2016
Actual Primary Completion Date :
Jul 25, 2017
Actual Study Completion Date :
Jul 25, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Assay-guided treatment (AGT)

Assay results will be provided to the treating investigator, who will use the results to guide pharmacotherapy of the subject's MDD treatment.

Genetic: Assay-guided treatment (AGT)
The assay provides information to guide pharmacotherapeutic decisions personalized to a patient's genetic profile, to maximize improvement in symptomatology and minimize treatment failure and treatment intolerability.
Other Names:
  • Genecept Assay™
  • Placebo Comparator: Treatment-as-usual (TAU)

    The treating investigator will treat subjects of the TAU group without the knowledge of the pharmacogenetic testing results.

    Other: Treatment-as-usual (TAU)
    Subjects are treated-as-usual without the aid of the assay.

    Outcome Measures

    Primary Outcome Measures

    1. Mean Change From Baseline in SIGH-D-17 Score at 8 Weeks. [Baseline to 8 Weeks]

      SIGH-D-17: 17-item rater-administered Structured Interview Guide of the Hamilton Depression Rating Scale Scoring is based on the 17-item scale and scores range from 0 minimum to 52 maximum. Scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression; the maximum score being 52 on the 17-point scale.

    Secondary Outcome Measures

    1. Mean Change From Baseline in QIDS-SR16 Score at 8 Weeks. [Baseline to 8 Weeks]

      QIDS-SR16: 16-item Quick Inventory of Depressive Symptomatology Self-Report QIDS-SR16 ranges from a score of 0 minimum to 27 maximum. In terms of severity of depression, Scores of 0 to 5 reflect "none", scores of 6 to 15 reflect "mild", scores of 7-20 reflect "moderate and scores of 21 to 27 reflect "severe" depression.

    2. Percentage of Treatment Responders at Week 8 Based on ≥ 50% Reduction of SIGH-D-17 Score From Baseline. [Baseline to 8 Weeks]

      SIGH-D-17: 17-item rater-administered Structured Interview Guide of the Hamilton Depression Rating Scale

    3. Percentage of Treatment Responders at Week 8 Based on ≥ 50% Reduction of QIDS-SR16 Score From Baseline. [Baseline to 8 Weeks]

      QIDS-SR16: 16-item Quick Inventory of Depressive Symptomatology Self-Report QIDS-SR16 ranges from a score of 0 minimum to 27 maximum. In terms of severity of depression, Scores of 0 to 5 reflect "none", scores of 6 to 15 reflect "mild", scores of 7-20 reflect "moderate and scores of 21 to 27 reflect "severe" depression.

    4. Percentage of Treatment Responders at Week 8 Based on ≤ 3 Score on the CGI-I. [Baseline to 8 Weeks]

      CGI-I: Clinical Global Impression Improvement scale; a clinician-rated scale that measures the improvement or worsening of a patient's symptoms The CGI-I is rated on a 7-point scale, with the improvement in severity of illness scale using a range of responses from 1 (Very much improved) through to 7 (Very much worse). A score of 0 indicates Patient was not able to be assessed

    5. Percentage of Remitters at Week 8 Based on ≤ 7 Score on the SIGH-D-17. [Baseline to 8 Weeks]

      SIGH-D-17: 17-item rater-administered Structured Interview Guide of the Hamilton Depression Rating Scale Scoring is based on the 17-item scale and scores range from 0 minimum to 52 maximum. Scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression; the maximum score being 52 on the 17-point scale.

    6. Percentage of Remitters at Week 8 Based on ≤ 5 Score on the QIDS-SR16. [Baseline to 8 Weeks]

      QIDS-SR16: 16-item Quick Inventory of Depressive Symptomatology Self-Report QIDS-SR16 ranges from a score of 0 minimum to 27 maximum. In terms of severity of depression, Scores of 0 to 5 reflect "none", scores of 6 to 15 reflect "mild", scores of 7-20 reflect "moderate and scores of 21 to 27 reflect "severe" depression.

    7. Safety Outcomes Based on Frequency, Intensity and Burden of Side Effects Rating (FIBSER). [Baseline to 8 Weeks]

      A 3-question patient-rated scale for assessing frequency, intensity, and burden of medication side effects for patients receiving treatment for depression. The Frequency, Intensity, and Burden of Side Effects-Rating (FIBSER) questionnaire uses 3 questions with a 6-point Likert measurement scale. A score of 0-2 on question 3 (burden of side effects) represents an acceptable low side-effect burden usually requiring no treatment adjustment. A score of 3 or 4 indicates moderate side-effect burden that should be evaluated further (eg, timing related to dose change, patient concerns, etc), and an adjustment such as a dose decrease considered. A score of 5 or 6 indicates a high burden warranting a change such as dose decrease, switching, or direct treatment of the side effect(s).

    8. Safety Outcomes Based on Frequency and Severity of Reported Adverse Events. [Screening to 8 Weeks]

      Untoward medical occurrence in a subject administered a pharmaceutical product which does not necessarily have to have a causal relationship with treatment. As based on FIBSER The Frequency, Intensity, and Burden of Side Effects-Rating (FIBSER) questionnaire uses 3 questions with a 6-point Likert measurement scale. A score of 0-2 on question 3 (burden of side effects) represents an acceptable low side-effect burden usually requiring no treatment adjustment. A score of 3 or 4 indicates moderate side-effect burden that should be evaluated further (eg, timing related to dose change, patient concerns, etc), and an adjustment such as a dose decrease considered. A score of 5 or 6 indicates a high burden warranting a change such as dose decrease, switching, or direct treatment of the side effect(s). Scores refer to intensity, frequency and interference.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Age 18-75 years; Sub-Group Age =/> 65 years

    2. Ability to understand and provide informed consent

    3. Ability to understand, read and speak English

    4. Primary diagnosis of Major Depressive Disorder (without psychosis) based on DSM-5 criteria and MINI 7.0

    5. SIGH-D-17 score >18 (i.e., moderate depression) at Screening and Baseline

    6. Failure of at least 1 prior adequate trial of standard antidepressant in the current major depressive episode (using ATRQ criteria - i.e., 6 weeks at adequate dose) due to inefficacy, side effects or intolerability

    7. Subject is willing to follow study instructions, complete study assessments and likely to complete all required visits

    Exclusion Criteria:
    1. Severe personality traits (based on DSM-5 criteria) that in the opinion of the investigator may interfere with the participation in the study or the evaluation of efficacy and safety and all diagnosed Personality Disorders

    2. Current DSM-5 diagnosis of Neurocognitive Disorders, Schizophrenia Spectrum (lifetime diagnosis) and other Psychotic Disorders, Bipolar and Related disorders (lifetime diagnosis*), Trauma and Stress related Disorders, Obsessive Compulsive Disorder and Related Disorders. Other DSM-5 disorders that in the opinion of the investigator may interfere with the participation in the study or the evaluation of efficacy and safety.

    3. DSM-5 diagnosis of Substance Related and Addictive Disorders diagnosed in the last 12 months (other than tobacco and caffeine)

    4. History of Suicidal Behavior within 12 months of screening or presence of Active Suicidal Ideation with Intent in the past 12 months (Items 4 or 5) at Screening or Baseline, as determined by the Columbia Suicide Severity Rating Scale (C-SSRS), or subject is considered to be an acute suicide risk in the clinical judgment of the investigator

    5. Previous homicidal behavior or acute homicidal risk at Screening or Baseline, in the clinical judgment of the investigator

    6. Four (4) or more failed pharmacologic interventions for depression in the current major depressive episode (One of the four failed interventions must meet ATRQ criteria

    • i.e., 6 weeks at adequate dose).
    1. Subjects who are not willing to take psychotropic medications for treatment of MDD.

    2. Electroconvulsive therapy (ECT) or transcranial magnetic stimulation therapy (TMS) started within 90 days of screening or planned during the study.

    3. Subjects with a vagus nerve or deep brain stimulator are prohibited from the trial.

    4. Psychotherapy including cognitive behavioral therapy (CBT), or dialectical behavioral therapy (DBT) started within 90 days of screening or planned during the study.

    5. Unstable or active medical condition(s) which in the opinion of the investigator would jeopardize the subject's safety or interfere with participation of the study or confound evaluation of efficacy or safety.

    6. Current diagnosis of unstable hypothyroidism.

    7. Females who are pregnant, nursing, or planning a pregnancy during the study or believe they may be pregnant at Screening or Baseline.

    8. Participation in another investigative trial within 30 days of screening

    9. Subject previously treated with the use of a similar psychotropic genetic testing assay.

    10. Subject tests positive for illicit drug use on the urine drug screen (UDS) at the screen visit (including Marijuana where legal).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama - Birmingham Birmingham Alabama United States 35294
    2 Noesis Pharma Phoenix Arizona United States 85032
    3 Woodland Research Northwest Springdale Arkansas United States 72764
    4 Collaborative Neuroscience Network, Inc. - Garden Grove Garden Grove California United States 92845
    5 Pacific Institute of Medical Research Los Angeles California United States 90024
    6 Pacific Research Partners, LLC Oakland California United States 94612
    7 Artemis Institute for Clinical Research San Diego California United States 92103
    8 Collaborative Neuroscience Network, Inc. - Torrance Torrance California United States 90502
    9 Pacific Clinical Research Medical Group Upland California United States 91786
    10 Florida Clinical Research Center, LLC - Bradenton Bradenton Florida United States 34201
    11 Clinical Neuroscience Solutions Inc. - Jacksonville Jacksonville Florida United States 32256
    12 Florida Clinical Research Center, LLC - Maitland Maitland Florida United States 32751
    13 Clinical Neuroscience Solutions Inc. - Orlando Orlando Florida United States 32801
    14 Chicago Research Center, Inc. Chicago Illinois United States 60634
    15 Boston Clinical Trials Boston Massachusetts United States 02131
    16 Premier Psychiatric Research Institute, LLC Lincoln Nebraska United States 68526
    17 Richard H Weisler MD, PA and Associates Raleigh North Carolina United States 27609
    18 Midwest Clinical Research Center Dayton Ohio United States 45417
    19 IPS Research Company Oklahoma City Oklahoma United States 73103
    20 Thomas Jefferson University Mood Disorder Program Philadelphia Pennsylvania United States 19107
    21 Clinical Neuroscience Solutions Inc. - Memphis Memphis Tennessee United States 38119
    22 BioBehavioral Research of Austin, PC Austin Texas United States 78759
    23 University of Virginia Center for Psychiatric Research Charlottesville Virginia United States 22903

    Sponsors and Collaborators

    • Genomind, LLC
    • Medpace, Inc.

    Investigators

    • Study Chair: David Krause, MD, Genomind CMO

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Genomind, LLC
    ClinicalTrials.gov Identifier:
    NCT02634177
    Other Study ID Numbers:
    • GNM-PROT MDD-01
    First Posted:
    Dec 17, 2015
    Last Update Posted:
    Aug 28, 2020
    Last Verified:
    Oct 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Genomind, LLC
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail 304 Randomized
    Arm/Group Title Assay-guided Treatment (AGT) Treatment-as-usual (TAU)
    Arm/Group Description Assay results will be provided to the treating investigator, who will use the results to guide pharmacotherapy of the subject's MDD treatment. Assay-guided treatment (AGT): The assay provides information to guide pharmacotherapeutic decisions personalized to a patient's genetic profile, to maximize improvement in symptomatology and minimize treatment failure and treatment intolerability. The treating investigator will treat subjects of the TAU group without the knowledge of the pharmacogenetic testing results. Treatment-as-usual (TAU): Subjects are treated-as-usual without the aid of the assay.
    Period Title: Overall Study
    STARTED 151 153
    COMPLETED 140 141
    NOT COMPLETED 11 12

    Baseline Characteristics

    Arm/Group Title Assay-guided Treatment (AGT) Treatment-as-usual (TAU) Total
    Arm/Group Description Assay results will be provided to the treating investigator, who will use the results to guide pharmacotherapy of the subject's MDD treatment. Assay-guided treatment (AGT): The assay provides information to guide pharmacotherapeutic decisions personalized to a patient's genetic profile, to maximize improvement in symptomatology and minimize treatment failure and treatment intolerability. The treating investigator will treat subjects of the TAU group without the knowledge of the pharmacogenetic testing results. Treatment-as-usual (TAU): Subjects are treated-as-usual without the aid of the assay. Total of all reporting groups
    Overall Participants 151 153 304
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    47.8
    (12.38)
    47.6
    (12.03)
    47.7
    (12.20)
    Sex: Female, Male (Count of Participants)
    Female
    107
    70.9%
    111
    72.5%
    218
    71.7%
    Male
    44
    29.1%
    42
    27.5%
    86
    28.3%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    2
    1.3%
    1
    0.7%
    3
    1%
    Asian
    0
    0%
    1
    0.7%
    1
    0.3%
    Native Hawaiian or Other Pacific Islander
    1
    0.7%
    2
    1.3%
    3
    1%
    Black or African American
    33
    21.9%
    38
    24.8%
    71
    23.4%
    White
    111
    73.5%
    110
    71.9%
    221
    72.7%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    4
    2.6%
    1
    0.7%
    5
    1.6%
    Region of Enrollment (participants) [Number]
    United States
    151
    100%
    153
    100%
    304
    100%
    Body Weight (kg) at Screening (kg) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg]
    88.59
    (22.338)
    89.28
    (24.787)
    88.93
    (23.566)
    Height at Screening (cm) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [cm]
    168.3
    (10.64)
    168.0
    (9.41)
    168.1
    (10.03)
    BMI at Screening (kg/m^2) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg/m^2]
    31.27
    (7.491)
    31.62
    (8.443)
    31.45
    (7.973)

    Outcome Measures

    1. Primary Outcome
    Title Mean Change From Baseline in SIGH-D-17 Score at 8 Weeks.
    Description SIGH-D-17: 17-item rater-administered Structured Interview Guide of the Hamilton Depression Rating Scale Scoring is based on the 17-item scale and scores range from 0 minimum to 52 maximum. Scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression; the maximum score being 52 on the 17-point scale.
    Time Frame Baseline to 8 Weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Assay-guided Treatment (AGT) Treatment-as-usual (TAU)
    Arm/Group Description Assay results will be provided to the treating investigator, who will use the results to guide pharmacotherapy of the subject's MDD treatment. Assay-guided treatment (AGT): The assay provides information to guide pharmacotherapeutic decisions personalized to a patient's genetic profile, to maximize improvement in symptomatology and minimize treatment failure and treatment intolerability. The treating investigator will treat subjects of the TAU group without the knowledge of the pharmacogenetic testing results. Treatment-as-usual (TAU): Subjects are treated-as-usual without the aid of the assay.
    Measure Participants 138 140
    Mean (Standard Deviation) [units on a scale]
    -9.70
    (6.411)
    -10.16
    (6.689)
    2. Secondary Outcome
    Title Mean Change From Baseline in QIDS-SR16 Score at 8 Weeks.
    Description QIDS-SR16: 16-item Quick Inventory of Depressive Symptomatology Self-Report QIDS-SR16 ranges from a score of 0 minimum to 27 maximum. In terms of severity of depression, Scores of 0 to 5 reflect "none", scores of 6 to 15 reflect "mild", scores of 7-20 reflect "moderate and scores of 21 to 27 reflect "severe" depression.
    Time Frame Baseline to 8 Weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Assay-guided Treatment (AGT) Treatment-as-usual (TAU)
    Arm/Group Description Assay results will be provided to the treating investigator, who will use the results to guide pharmacotherapy of the subject's MDD treatment. Assay-guided treatment (AGT): The assay provides information to guide pharmacotherapeutic decisions personalized to a patient's genetic profile, to maximize improvement in symptomatology and minimize treatment failure and treatment intolerability. The treating investigator will treat subjects of the TAU group without the knowledge of the pharmacogenetic testing results. Treatment-as-usual (TAU): Subjects are treated-as-usual without the aid of the assay.
    Measure Participants 138 141
    Mean (Standard Deviation) [units on a scale]
    -6.04
    (5.407)
    -6.45
    (5.135)
    3. Secondary Outcome
    Title Percentage of Treatment Responders at Week 8 Based on ≥ 50% Reduction of SIGH-D-17 Score From Baseline.
    Description SIGH-D-17: 17-item rater-administered Structured Interview Guide of the Hamilton Depression Rating Scale
    Time Frame Baseline to 8 Weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Assay-guided Treatment (AGT) Treatment-as-usual (TAU)
    Arm/Group Description Assay results will be provided to the treating investigator, who will use the results to guide pharmacotherapy of the subject's MDD treatment. Assay-guided treatment (AGT): The assay provides information to guide pharmacotherapeutic decisions personalized to a patient's genetic profile, to maximize improvement in symptomatology and minimize treatment failure and treatment intolerability. The treating investigator will treat subjects of the TAU group without the knowledge of the pharmacogenetic testing results. Treatment-as-usual (TAU): Subjects are treated-as-usual without the aid of the assay.
    Measure Participants 138 140
    Count of Participants [Participants]
    58
    38.4%
    72
    47.1%
    4. Secondary Outcome
    Title Percentage of Treatment Responders at Week 8 Based on ≥ 50% Reduction of QIDS-SR16 Score From Baseline.
    Description QIDS-SR16: 16-item Quick Inventory of Depressive Symptomatology Self-Report QIDS-SR16 ranges from a score of 0 minimum to 27 maximum. In terms of severity of depression, Scores of 0 to 5 reflect "none", scores of 6 to 15 reflect "mild", scores of 7-20 reflect "moderate and scores of 21 to 27 reflect "severe" depression.
    Time Frame Baseline to 8 Weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Assay-guided Treatment (AGT) Treatment-as-usual (TAU)
    Arm/Group Description Assay results will be provided to the treating investigator, who will use the results to guide pharmacotherapy of the subject's MDD treatment. Assay-guided treatment (AGT): The assay provides information to guide pharmacotherapeutic decisions personalized to a patient's genetic profile, to maximize improvement in symptomatology and minimize treatment failure and treatment intolerability. The treating investigator will treat subjects of the TAU group without the knowledge of the pharmacogenetic testing results. Treatment-as-usual (TAU): Subjects are treated-as-usual without the aid of the assay.
    Measure Participants 140 141
    Count of Participants [Participants]
    57
    37.7%
    65
    42.5%
    5. Secondary Outcome
    Title Percentage of Treatment Responders at Week 8 Based on ≤ 3 Score on the CGI-I.
    Description CGI-I: Clinical Global Impression Improvement scale; a clinician-rated scale that measures the improvement or worsening of a patient's symptoms The CGI-I is rated on a 7-point scale, with the improvement in severity of illness scale using a range of responses from 1 (Very much improved) through to 7 (Very much worse). A score of 0 indicates Patient was not able to be assessed
    Time Frame Baseline to 8 Weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Assay-guided Treatment (AGT) Treatment-as-usual (TAU)
    Arm/Group Description Assay results will be provided to the treating investigator, who will use the results to guide pharmacotherapy of the subject's MDD treatment. Assay-guided treatment (AGT): The assay provides information to guide pharmacotherapeutic decisions personalized to a patient's genetic profile, to maximize improvement in symptomatology and minimize treatment failure and treatment intolerability. The treating investigator will treat subjects of the TAU group without the knowledge of the pharmacogenetic testing results. Treatment-as-usual (TAU): Subjects are treated-as-usual without the aid of the assay.
    Measure Participants 140 141
    Count of Participants [Participants]
    128
    84.8%
    118
    77.1%
    6. Secondary Outcome
    Title Percentage of Remitters at Week 8 Based on ≤ 7 Score on the SIGH-D-17.
    Description SIGH-D-17: 17-item rater-administered Structured Interview Guide of the Hamilton Depression Rating Scale Scoring is based on the 17-item scale and scores range from 0 minimum to 52 maximum. Scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression; the maximum score being 52 on the 17-point scale.
    Time Frame Baseline to 8 Weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Assay-guided Treatment (AGT) Treatment-as-usual (TAU)
    Arm/Group Description Assay results will be provided to the treating investigator, who will use the results to guide pharmacotherapy of the subject's MDD treatment. Assay-guided treatment (AGT): The assay provides information to guide pharmacotherapeutic decisions personalized to a patient's genetic profile, to maximize improvement in symptomatology and minimize treatment failure and treatment intolerability. The treating investigator will treat subjects of the TAU group without the knowledge of the pharmacogenetic testing results. Treatment-as-usual (TAU): Subjects are treated-as-usual without the aid of the assay.
    Measure Participants 138 140
    Count of Participants [Participants]
    35
    23.2%
    46
    30.1%
    7. Secondary Outcome
    Title Percentage of Remitters at Week 8 Based on ≤ 5 Score on the QIDS-SR16.
    Description QIDS-SR16: 16-item Quick Inventory of Depressive Symptomatology Self-Report QIDS-SR16 ranges from a score of 0 minimum to 27 maximum. In terms of severity of depression, Scores of 0 to 5 reflect "none", scores of 6 to 15 reflect "mild", scores of 7-20 reflect "moderate and scores of 21 to 27 reflect "severe" depression.
    Time Frame Baseline to 8 Weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Assay-guided Treatment (AGT) Treatment-as-usual (TAU)
    Arm/Group Description Assay results will be provided to the treating investigator, who will use the results to guide pharmacotherapy of the subject's MDD treatment. Assay-guided treatment (AGT): The assay provides information to guide pharmacotherapeutic decisions personalized to a patient's genetic profile, to maximize improvement in symptomatology and minimize treatment failure and treatment intolerability. The treating investigator will treat subjects of the TAU group without the knowledge of the pharmacogenetic testing results. Treatment-as-usual (TAU): Subjects are treated-as-usual without the aid of the assay.
    Measure Participants 140 141
    Count of Participants [Participants]
    43
    28.5%
    47
    30.7%
    8. Secondary Outcome
    Title Safety Outcomes Based on Frequency, Intensity and Burden of Side Effects Rating (FIBSER).
    Description A 3-question patient-rated scale for assessing frequency, intensity, and burden of medication side effects for patients receiving treatment for depression. The Frequency, Intensity, and Burden of Side Effects-Rating (FIBSER) questionnaire uses 3 questions with a 6-point Likert measurement scale. A score of 0-2 on question 3 (burden of side effects) represents an acceptable low side-effect burden usually requiring no treatment adjustment. A score of 3 or 4 indicates moderate side-effect burden that should be evaluated further (eg, timing related to dose change, patient concerns, etc), and an adjustment such as a dose decrease considered. A score of 5 or 6 indicates a high burden warranting a change such as dose decrease, switching, or direct treatment of the side effect(s).
    Time Frame Baseline to 8 Weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Assay-guided Treatment (AGT) Treatment-as-usual (TAU)
    Arm/Group Description Assay results will be provided to the treating investigator, who will use the results to guide pharmacotherapy of the subject's MDD treatment. Assay-guided treatment (AGT): The assay provides information to guide pharmacotherapeutic decisions personalized to a patient's genetic profile, to maximize improvement in symptomatology and minimize treatment failure and treatment intolerability. The treating investigator will treat subjects of the TAU group without the knowledge of the pharmacogenetic testing results. Treatment-as-usual (TAU): Subjects are treated-as-usual without the aid of the assay.
    Measure Participants 124 127
    Mean (Standard Deviation) [units on a scale]
    -.02
    (1.55)
    -.02
    (1.55)
    9. Secondary Outcome
    Title Safety Outcomes Based on Frequency and Severity of Reported Adverse Events.
    Description Untoward medical occurrence in a subject administered a pharmaceutical product which does not necessarily have to have a causal relationship with treatment. As based on FIBSER The Frequency, Intensity, and Burden of Side Effects-Rating (FIBSER) questionnaire uses 3 questions with a 6-point Likert measurement scale. A score of 0-2 on question 3 (burden of side effects) represents an acceptable low side-effect burden usually requiring no treatment adjustment. A score of 3 or 4 indicates moderate side-effect burden that should be evaluated further (eg, timing related to dose change, patient concerns, etc), and an adjustment such as a dose decrease considered. A score of 5 or 6 indicates a high burden warranting a change such as dose decrease, switching, or direct treatment of the side effect(s). Scores refer to intensity, frequency and interference.
    Time Frame Screening to 8 Weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Assay-guided Treatment (AGT) Treatment-as-usual (TAU)
    Arm/Group Description Assay results will be provided to the treating investigator, who will use the results to guide pharmacotherapy of the subject's MDD treatment. Assay-guided treatment (AGT): The assay provides information to guide pharmacotherapeutic decisions personalized to a patient's genetic profile, to maximize improvement in symptomatology and minimize treatment failure and treatment intolerability. The treating investigator will treat subjects of the TAU group without the knowledge of the pharmacogenetic testing results. Treatment-as-usual (TAU): Subjects are treated-as-usual without the aid of the assay.
    Measure Participants 124 127
    Frequency of the side effects for the past week
    -0.1
    (2.18)
    -0.2
    (2.18)
    Intensity of the side effects over the last week
    0.0
    (1.86)
    0.0
    (1.9)
    Interference of day-to-day functions over the last
    -0.2
    (1.55)
    -0.2
    (1.59)

    Adverse Events

    Time Frame AEs were collected at all study visits screening to Week 8
    Adverse Event Reporting Description Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
    Arm/Group Title Assay-guided Treatment (AGT) Treatment-as-usual (TAU)
    Arm/Group Description Assay results will be provided to the treating investigator, who will use the results to guide pharmacotherapy of the subject's MDD treatment. Assay-guided treatment (AGT): The assay provides information to guide pharmacotherapeutic decisions personalized to a patient's genetic profile, to maximize improvement in symptomatology and minimize treatment failure and treatment intolerability. The treating investigator will treat subjects of the TAU group without the knowledge of the pharmacogenetic testing results. Treatment-as-usual (TAU): Subjects are treated-as-usual without the aid of the assay.
    All Cause Mortality
    Assay-guided Treatment (AGT) Treatment-as-usual (TAU)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/150 (0%) 0/153 (0%)
    Serious Adverse Events
    Assay-guided Treatment (AGT) Treatment-as-usual (TAU)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 6/150 (4%) 3/153 (2%)
    Hepatobiliary disorders
    Cholelithiasis 0/150 (0%) 0 1/153 (0.7%) 1
    Infections and infestations
    Pneumonia 2/150 (1.3%) 2 0/153 (0%) 0
    Appendicitis 1/150 (0.7%) 1 0/153 (0%) 0
    Streptococcal sepsis 1/150 (0.7%) 1 0/153 (0%) 0
    Nervous system disorders
    Multiple sclerosis 0/150 (0%) 0 1/153 (0.7%) 1
    Syncope 1/150 (0.7%) 1 0/153 (0%) 0
    Psychiatric disorders
    Depression 0/150 (0%) 0 1/153 (0.7%) 1
    Respiratory, thoracic and mediastinal disorders
    Asthma 1/150 (0.7%) 1 0/153 (0%) 0
    Other (Not Including Serious) Adverse Events
    Assay-guided Treatment (AGT) Treatment-as-usual (TAU)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 107/150 (71.3%) 111/153 (72.5%)
    Blood and lymphatic system disorders
    Anaemia 1/150 (0.7%) 1 0/153 (0%) 0
    Lymphadenopathy 1/150 (0.7%) 1 0/153 (0%) 0
    Microcytic anaemia 1/150 (0.7%) 1 0/153 (0%) 0
    Thrombocytopenia 1/150 (0.7%) 1 0/153 (0%) 0
    Cardiac disorders
    Palpitations 5/150 (3.3%) 5 4/153 (2.6%) 4
    Tachycardia 0/150 (0%) 0 3/153 (2%) 3
    Angina pectoris 0/150 (0%) 0 1/153 (0.7%) 1
    Bradycardia 1/150 (0.7%) 1 0/153 (0%) 0
    Coronary artery dilatation 1/150 (0.7%) 1 0/153 (0%) 0
    Coronary ostial stenosis 1/150 (0.7%) 1 0/153 (0%) 0
    Hypertensive crisis 1/150 (0.7%) 1 0/153 (0%) 0
    Ear and labyrinth disorders
    Tinnitus 5/150 (3.3%) 5 3/153 (2%) 3
    Ear pain 0/150 (0%) 0 1/153 (0.7%) 1
    Vertigo 1/150 (0.7%) 1 0/153 (0%) 0
    Endocrine disorders
    Adrenal mass 1/150 (0.7%) 1 0/153 (0%) 0
    Eye disorders
    Vision blurred 1/150 (0.7%) 1 7/153 (4.6%) 7
    Dry eye 0/150 (0%) 0 2/153 (1.3%) 2
    Blepharitis 1/150 (0.7%) 1 0/153 (0%) 0
    Blepharospasm 0/150 (0%) 0 1/153 (0.7%) 1
    Eye pruritus 0/150 (0%) 0 1/153 (0.7%) 1
    Periorbital edema 1/150 (0.7%) 1 0/153 (0%) 0
    Gastrointestinal disorders
    Dry mouth 22/150 (14.7%) 22 15/153 (9.8%) 15
    Nausea 15/150 (10%) 15 17/153 (11.1%) 17
    Diarrhea 11/150 (7.3%) 11 14/153 (9.2%) 14
    Constipation 13/150 (8.7%) 13 7/153 (4.6%) 7
    Abdominal pain 1/150 (0.7%) 1 3/153 (2%) 3
    Abdominal pain upper 3/150 (2%) 3 1/153 (0.7%) 1
    Dyspepsia 2/150 (1.3%) 2 2/153 (1.3%) 2
    Vomiting 3/150 (2%) 3 1/153 (0.7%) 1
    Abdominal discomfort 3/150 (2%) 3 0/153 (0%) 0
    Abdominal distension 1/150 (0.7%) 1 2/153 (1.3%) 2
    Toothache 1/150 (0.7%) 1 2/153 (1.3%) 2
    Gastroesophageal reflux disease 1/150 (0.7%) 1 1/153 (0.7%) 1
    Abdominal pain lower 1/150 (0.7%) 1 0/153 (0%) 0
    Feces discoloured 1/150 (0.7%) 1 0/153 (0%) 0
    Feces soft 0/150 (0%) 0 1/153 (0.7%) 1
    Flatulence 0/150 (0%) 0 1/153 (0.7%) 1
    Large intestinal stenosis 1/150 (0.7%) 1 0/153 (0%) 0
    Uvulitis 1/150 (0.7%) 1 0/153 (0%) 0
    General disorders
    Fatigue 6/150 (4%) 6 4/153 (2.6%) 4
    Chest pain 2/150 (1.3%) 2 1/153 (0.7%) 1
    Non-cardiac chest pain 0/150 (0%) 0 2/153 (1.3%) 2
    Edema peripheral 0/150 (0%) 0 2/153 (1.3%) 2
    Chest discomfort 1/150 (0.7%) 1 0/153 (0%) 0
    Crying 0/150 (0%) 0 1/153 (0.7%) 1
    Drug withdrawal syndrome 0/150 (0%) 0 1/153 (0.7%) 1
    Feeling hot 1/150 (0.7%) 1 0/153 (0%) 0
    Pyrexia 0/150 (0%) 0 1/153 (0.7%) 1
    Immune system disorders
    Hypersensitivity 0/150 (0%) 0 2/153 (1.3%) 2
    Seasonal allergy 0/150 (0%) 0 1/153 (0.7%) 1
    Infections and infestations
    Upper respiratory tract infection 7/150 (4.7%) 7 4/153 (2.6%) 4
    Bronchitis 3/150 (2%) 3 4/153 (2.6%) 4
    Sinusitis 2/150 (1.3%) 2 1/153 (0.7%) 1
    Gastroenteritis 1/150 (0.7%) 1 1/153 (0.7%) 1
    Influenza 0/150 (0%) 0 2/153 (1.3%) 2
    Viral infection 2/150 (1.3%) 2 1/153 (0.7%) 1
    Bacterial vaginosis 0/150 (0%) 0 1/153 (0.7%) 1
    Cellulitis 1/150 (0.7%) 1 0/153 (0%) 0
    Ear infection 1/150 (0.7%) 1 0/153 (0%) 0
    Gastroenteritis viral 0/150 (0%) 0 1/153 (0.7%) 1
    Laryngitis 0/150 (0%) 0 1/153 (0.7%) 1
    Nasopharyngitis 1/150 (0.7%) 1 0/153 (0%) 0
    Papilloma viral infection 0/150 (0%) 0 1/153 (0.7%) 1
    Rhinitis 1/150 (0.7%) 1 0/153 (0%) 0
    Tinea pedis 1/150 (0.7%) 1 0/153 (0%) 0
    Tooth infection 1/150 (0.7%) 1 0/153 (0%) 0
    Urinary tract infection 0/150 (0%) 0 1/153 (0.7%) 1
    Vulvovaginal mycotic infection 1/150 (0.7%) 1 0/153 (0%) 0
    Pruritus 3/150 (2%) 3 3/153 (2%) 3
    Injury, poisoning and procedural complications
    Joint injury 2/150 (1.3%) 2 0/153 (0%) 0
    Contusion 1/150 (0.7%) 1 0/153 (0%) 0
    Fall 1/150 (0.7%) 1 0/153 (0%) 0
    Heat stroke 1/150 (0.7%) 1 0/153 (0%) 0
    Muscle strain 1/150 (0.7%) 1 0/153 (0%) 0
    Procedural pain 0/150 (0%) 0 1/153 (0.7%) 1
    Investigations
    Weight increased 0/150 (0%) 0 1/153 (0.7%) 1
    White blood cell count increased 1/150 (0.7%) 1 0/153 (0%) 0
    Metabolism and nutrition disorders
    Increased appetite 7/150 (4.7%) 7 5/153 (3.3%) 5
    Decreased appetite 1/150 (0.7%) 1 5/153 (3.3%) 5
    Dehydration 1/150 (0.7%) 1 0/153 (0%) 0
    Hypoglycaemia 0/150 (0%) 0 1/153 (0.7%) 1
    Musculoskeletal and connective tissue disorders
    Back pain 3/150 (2%) 3 1/153 (0.7%) 1
    Muscle tightness 1/150 (0.7%) 1 1/153 (0.7%) 1
    Arthralgia 0/150 (0%) 0 1/153 (0.7%) 1
    Fibromyalgia 0/150 (0%) 0 1/153 (0.7%) 1
    Foot deformity 0/150 (0%) 0 1/153 (0.7%) 1
    Limb discomfort 0/150 (0%) 0 1/153 (0.7%) 1
    Muscle spasms 1/150 (0.7%) 1 0/153 (0%) 0
    Muscle twitching 0/150 (0%) 0 1/153 (0.7%) 1
    Musculoskeletal chest pain 0/150 (0%) 0 1/153 (0.7%) 1
    Musculoskeletal pain 0/150 (0%) 0 1/153 (0.7%) 1
    Myalgia 1/150 (0.7%) 1 0/153 (0%) 0
    Pain in extremity 1/150 (0.7%) 1 0/153 (0%) 0
    Pain in jaw 1/150 (0.7%) 1 0/153 (0%) 0
    Temporomandibular joint syndrome 0/150 (0%) 0 1/153 (0.7%) 1
    Nervous system disorders
    Headache 22/150 (14.7%) 22 15/153 (9.8%) 15
    Dizziness 13/150 (8.7%) 13 19/153 (12.4%) 19
    Somnolence 5/150 (3.3%) 5 10/153 (6.5%) 10
    Sedation 7/150 (4.7%) 7 4/153 (2.6%) 4
    Coordination abnormal 2/150 (1.3%) 2 6/153 (3.9%) 6
    Tremor 2/150 (1.3%) 2 6/153 (3.9%) 6
    Dizziness postural 2/150 (1.3%) 2 2/153 (1.3%) 2
    Dysgeusia 2/150 (1.3%) 2 2/153 (1.3%) 2
    Hypersomnia 1/150 (0.7%) 1 2/153 (1.3%) 2
    Tension headache 3/150 (2%) 3 0/153 (0%) 0
    Disturbance in attention 1/150 (0.7%) 1 1/153 (0.7%) 1
    Restless legs syndrome 1/150 (0.7%) 1 1/153 (0.7%) 1
    Amnesia 0/150 (0%) 0 1/153 (0.7%) 1
    Complex regional pain syndrome 1/150 (0.7%) 1 0/153 (0%) 0
    Mental impairment 0/150 (0%) 0 1/153 (0.7%) 1
    Migraine 1/150 (0.7%) 1 0/153 (0%) 0
    Narcolepsy 1/150 (0.7%) 1 0/153 (0%) 0
    Neuropathy peripheral 0/150 (0%) 0 1/153 (0.7%) 1
    Paraesthesia 1/150 (0.7%) 1 0/153 (0%) 0
    Parosmia 1/150 (0.7%) 1 0/153 (0%) 0
    Psychomotor hyperactivity 1/150 (0.7%) 1 0/153 (0%) 0
    Sciatica 0/150 (0%) 0 1/153 (0.7%) 1
    Trigeminal neuralgia 0/150 (0%) 0 1/153 (0.7%) 1
    Psychiatric disorders
    Insomnia 10/150 (6.7%) 10 9/153 (5.9%) 9
    Anxiety 9/150 (6%) 9 7/153 (4.6%) 7
    Irritability 6/150 (4%) 6 10/153 (6.5%) 10
    Libido decreased 3/150 (2%) 3 9/153 (5.9%) 9
    Restlessness 4/150 (2.7%) 4 2/153 (1.3%) 2
    Abnormal dreams 1/150 (0.7%) 1 4/153 (2.6%) 4
    Bruxism 3/150 (2%) 3 1/153 (0.7%) 1
    Sleep disorder 2/150 (1.3%) 2 2/153 (1.3%) 2
    Suicidal ideation 3/150 (2%) 3 1/153 (0.7%) 1
    Anorgasmia 1/150 (0.7%) 1 2/153 (1.3%) 2
    Nightmare 1/150 (0.7%) 1 2/153 (1.3%) 2
    Middle insomnia 2/150 (1.3%) 2 0/153 (0%) 0
    Orgasm abnormal 1/150 (0.7%) 1 1/153 (0.7%) 1
    Agitation 1/150 (0.7%) 1 0/153 (0%) 0
    Alcohol withdrawal syndrome 1/150 (0.7%) 1 0/153 (0%) 0
    Anger 0/150 (0%) 0 1/153 (0.7%) 1
    Derealisation 0/150 (0%) 0 1/153 (0.7%) 1
    Disorientation 0/150 (0%) 0 1/153 (0.7%) 1
    Hallucination, visual 0/150 (0%) 0 1/153 (0.7%) 1
    Mental status changes 1/150 (0.7%) 1 0/153 (0%) 0
    Nervousness 1/150 (0.7%) 1 0/153 (0%) 0
    Panic attack 0/150 (0%) 0 1/153 (0.7%) 1
    Renal and urinary disorders
    Pollakiuria 5/150 (3.3%) 5 4/153 (2.6%) 4
    Dysuria 5/150 (3.3%) 5 1/153 (0.7%) 1
    Urinary hesitation 1/150 (0.7%) 1 1/153 (0.7%) 1
    Urinary retention 0/150 (0%) 0 2/153 (1.3%) 2
    Micturition frequency decreased 0/150 (0%) 0 1/153 (0.7%) 1
    Micturition urgency 1/150 (0.7%) 1 0/153 (0%) 0
    Reproductive system and breast disorders
    Erectile dysfunction 2/150 (1.3%) 2 0/153 (0%) 0
    Menstruation irregular 0/150 (0%) 0 1/153 (0.7%) 1
    Nocturnal emission 0/150 (0%) 0 1/153 (0.7%) 1
    Respiratory, thoracic and mediastinal disorders
    Cough 1/150 (0.7%) 1 1/153 (0.7%) 1
    Epistaxis 1/150 (0.7%) 1 0/153 (0%) 0
    Oropharyngeal pain 0/150 (0%) 0 1/153 (0.7%) 1
    Skin and subcutaneous tissue disorders
    Hyperhidrosis 11/150 (7.3%) 11 7/153 (4.6%) 7
    Dry skin 3/150 (2%) 3 5/153 (3.3%) 5
    Rash 5/150 (3.3%) 5 3/153 (2%) 3
    Alopecia 1/150 (0.7%) 1 1/153 (0.7%) 1
    Rash pruritic 2/150 (1.3%) 2 0/153 (0%) 0
    Psoriasis 0/150 (0%) 0 1/153 (0.7%) 1
    Rash macular 1/150 (0.7%) 1 0/153 (0%) 0
    Urticaria 1/150 (0.7%) 1 0/153 (0%) 0
    Vascular disorders
    Hot flush 2/150 (1.3%) 2 1/153 (0.7%) 1
    Hypertension 1/150 (0.7%) 1 2/153 (1.3%) 2
    Flushing 1/150 (0.7%) 1 1/153 (0.7%) 1
    Orthostatic hypotension 1/150 (0.7%) 1 0/153 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Chief Medical Officer
    Organization Genomind
    Phone 267-989-3461
    Email dkrause@genomind.com
    Responsible Party:
    Genomind, LLC
    ClinicalTrials.gov Identifier:
    NCT02634177
    Other Study ID Numbers:
    • GNM-PROT MDD-01
    First Posted:
    Dec 17, 2015
    Last Update Posted:
    Aug 28, 2020
    Last Verified:
    Oct 1, 2019