Genecept Assay™ vs. Treatment-as-Usual to Evaluate Efficacy of Assay-Guided Treatment in Adults With MDD
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 |
---|---|---|
|
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
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:
|
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
- 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
- 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.
- 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
- 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.
- 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
- 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.
- 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.
- 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).
- 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
Inclusion Criteria:
-
Age 18-75 years; Sub-Group Age =/> 65 years
-
Ability to understand and provide informed consent
-
Ability to understand, read and speak English
-
Primary diagnosis of Major Depressive Disorder (without psychosis) based on DSM-5 criteria and MINI 7.0
-
SIGH-D-17 score >18 (i.e., moderate depression) at Screening and Baseline
-
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
-
Subject is willing to follow study instructions, complete study assessments and likely to complete all required visits
Exclusion Criteria:
-
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
-
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.
-
DSM-5 diagnosis of Substance Related and Addictive Disorders diagnosed in the last 12 months (other than tobacco and caffeine)
-
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
-
Previous homicidal behavior or acute homicidal risk at Screening or Baseline, in the clinical judgment of the investigator
-
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).
-
Subjects who are not willing to take psychotropic medications for treatment of MDD.
-
Electroconvulsive therapy (ECT) or transcranial magnetic stimulation therapy (TMS) started within 90 days of screening or planned during the study.
-
Subjects with a vagus nerve or deep brain stimulator are prohibited from the trial.
-
Psychotherapy including cognitive behavioral therapy (CBT), or dialectical behavioral therapy (DBT) started within 90 days of screening or planned during the study.
-
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.
-
Current diagnosis of unstable hypothyroidism.
-
Females who are pregnant, nursing, or planning a pregnancy during the study or believe they may be pregnant at Screening or Baseline.
-
Participation in another investigative trial within 30 days of screening
-
Subject previously treated with the use of a similar psychotropic genetic testing assay.
-
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.- GNM-PROT MDD-01
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
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)
|
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)
|
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%
|
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%
|
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%
|
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%
|
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%
|
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)
|
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
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 |
dkrause@genomind.com |
- GNM-PROT MDD-01