Trial · NCT02109939
Genomics Used to Improve DEpression Decisions
NCT02109939, Not applicable, Completed, Assurex Health Inc.; results first posted 2020-01-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Genomics Used to Improve DEpression Decisions. Trials, record NCT02109939. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02109939
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Genomics Used to Improve DEpression Decisions
- NCT number
- NCT02109939
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 1,398 participants, actual
- Lead sponsor
- Assurex Health Inc.
- Conditions
- Major Depressive Disorder (MDD)
- Interventions
- GeneSight Psychotropic
- First posted
- 2014-04-10
- Last updated
- 2020-01-14
- Results first posted
- 2020-01-14
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change in the 17-item Hamilton Depression (HAM-D17) Score From Baseline to 8 Weeks | from baseline to end of Week 8 | Evaluate the impact of GeneSight Psychotropic on response to psychotropic treatment as judged by the mean percent change in the 17-item Hamilton Depression (HAM-D17) score from baseline to end of Week 8 of the study. Scores range from 0 to 50, and lower scores are better outcomes. Percent change is defined as (week 8 score -baseline score) / (baseline score) x 100. |
| Secondary | Percent Change in the 16-item Quick Inventory of Depression Symptomology (QIDS-C16) Score From Baseline to 8 Weeks | from baseline to end of Week 8 | Mean percent change in the 16-item Quick Inventory of Depression Symptomology (QIDS-C16) score from baseline to end of Week 8 of the study. Scores range from 0 to 27 with lower scores being better outcomes. Percent change is defined as (week 8 score - baseline score) / (baseline score) x 100. |
| Secondary | Percentage of Responders at Week 8 for HAM-D17 | Week 8 visit info | Adjusted percentage of responders at Week 8 in each treatment group on the 17-item Hamilton Depression Rating Scale (HAM-D17). A responder is defined as a participant with at least a 50% decrease from baseline in total scale score. Scores range from 0 to 50, and lower scores are better outcomes. |
| Secondary | Percentage of Responders at Week 12 for HAM-D17 | Week 12 visit info | \*Comment\*: For patients in TAU, clinicians were blinded to the pharmacogenomic test result until after completion of the week 8 visit. Because unblinding might have occurred for some patients prior to week 12 assessments, data collected at week 12 were no longer considered blinded and are not analyzed or reported. |
| Secondary | Percentage of Remitters at Week 12 Defined as HAM-D17 ≤7 | week 12 visit info | \*Comment\*: For patients in TAU, clinicians were blinded to the pharmacogenomic test result until after completion of the week 8 visit. Because unblinding might have occurred for some patients prior to week 12 assessments, data collected at week 12 were no longer considered blinded and are not analyzed or reported. |
| Secondary | Percentage of Remitters at Week 8 Defined as HAM-D17 ≤7 Each Treatment Group; | week 8 visit info | Adjusted percentage of remitters at Week 8 defined as a score ≤7 in the 17-item Hamilton Depression Rating Scale (HAM-D17) in each treatment group. Scores range from 0 to 50, and lower scores are better outcomes. |
| Secondary | Time to Response/Remission of Depressive Symptoms Over 8 Weeks; | week 4 and 8 visit info | \*Comment\*: Time to response/remission is not an outcome measure that can accurately be reported from the way the data was collected. As specified in the updated SAP before the blind was broken, this was not analyzed or reported. |
| Secondary | Percent Change in the 17-item Hamilton Depression (HAM-D17) Score From Baseline to 24 Weeks | Baseline to week 24 visits | Evaluate the impact of GeneSight Psychotropic on response to psychotropic treatment as judged by the mean percent change in the 17-item Hamilton Depression (HAM-D17) score from baseline to end of Week 24 of the study. Scores range from 0 to 50, and lower scores are better outcomes. Percent change is defined as (week 24 score -baseline score) / (baseline score) x 100. |
| Secondary | Percentage of Responders at Week 8 for QIDS-C16 | Week 8 visit info | Adjusted percentage of responders at Week 8 in each treatment group on the 16-item Quick Inventory of Depression Symptomology (QIDS-C16). A responder is defined as a participant with at least 50% decrease from baseline in total scale score. Scores range from 0 to 27 with lower scores being better outcomes. |
| Secondary | Percentage of Responders at Week 8 for PHQ-9 | Week 8 visit info | Adjusted percentage of responders at Week 8 in each treatment group on the 9-item Patient Health Questionnaire (PHQ-9). A responder is defined as a participant with at least 50% decrease from baseline in total scale score. Scores range from 0 to 27 with lower scores being better outcomes. |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change in the 17-item Hamilton Depression (HAM-D17) Score From Baseline to 8 Weeks | from baseline to end of Week 8 | Per-Protocol | percentage of change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change in the 16-item Quick Inventory of Depression Symptomology (QIDS-C16) Score From Baseline to 8 Weeks | from baseline to end of Week 8 | Intent-to-Treat | percentage of change | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Responders at Week 8 for HAM-D17 | Week 8 visit info | Per Protocol | percentage of subjects | NUMBER |
| SECONDARY | Percentage of Responders at Week 12 for HAM-D17 | Week 12 visit info | |||
| SECONDARY | Percentage of Remitters at Week 12 Defined as HAM-D17 ≤7 | week 12 visit info | |||
| SECONDARY | Percentage of Remitters at Week 8 Defined as HAM-D17 ≤7 Each Treatment Group; | week 8 visit info | Per Protocol | percentage of subjects | NUMBER |
| SECONDARY | Time to Response/Remission of Depressive Symptoms Over 8 Weeks; | week 4 and 8 visit info | |||
| SECONDARY | Percent Change in the 17-item Hamilton Depression (HAM-D17) Score From Baseline to 24 Weeks | Baseline to week 24 visits | Per Protocol - Due to unblinding before week 12 there was no longer a treatment as usual and guided treatment arm and it was pre-specified in the Protocol to include only the GeneSight Psychotropic Tested Arm/Group for this Outcome Measure | percentage of change | MEAN |
| SECONDARY | Percentage of Responders at Week 8 for QIDS-C16 | Week 8 visit info | Intent-to-treat | percentage of subjects | NUMBER |
| SECONDARY | Percentage of Responders at Week 8 for PHQ-9 | Week 8 visit info | Intent-to-treat | percentage of subjects | NUMBER |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 outcomesResults by group19
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change in the 17-item Hamilton Depression (HAM-D17) Score From Baseline to 8 Weeks | Treatment As Usual | -24.39 | Standard Error 1.22 | percentage of change | |
| Percent Change in the 17-item Hamilton Depression (HAM-D17) Score From Baseline to 8 Weeks | GeneSight Psychotropic Tested | -27.23 | Standard Error 1.27 | percentage of change | |
| Percent Change in the 16-item Quick Inventory of Depression Symptomology (QIDS-C16) Score From Baseline to 8 Weeks | GeneSight Psychotropic Tested | -35.107 | Standard Error 1.189 | percentage of change | |
| Percent Change in the 16-item Quick Inventory of Depression Symptomology (QIDS-C16) Score From Baseline to 8 Weeks | Treatment As Usual | -32.900 | Standard Error 1.147 | percentage of change | |
| Percentage of Responders at Week 8 for HAM-D17 | GeneSight Psychotropic Tested | 26.00 | percentage of subjects | ||
| Percentage of Responders at Week 8 for HAM-D17 | Treatment As Usual | 19.92 | percentage of subjects | ||
| Percentage of Remitters at Week 8 Defined as HAM-D17 ≤7 Each Treatment Group; | GeneSight Psychotropic Tested | 15.30 | percentage of subjects | ||
| Percentage of Remitters at Week 8 Defined as HAM-D17 ≤7 Each Treatment Group; | Treatment As Usual | 10.08 | percentage of subjects | ||
| Percent Change in the 17-item Hamilton Depression (HAM-D17) Score From Baseline to 24 Weeks | GeneSight Psychotropic Tested | 42.5 | Standard Error 1.52 | percentage of change | |
| Percentage of Responders at Week 8 for QIDS-C16 | GeneSight Psychotropic Tested | 34.14 | percentage of subjects |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | GeneSight Psychotropic Tested | 681 | |
| Overall Study | STARTED | Treatment As Usual | 717 | |
| Overall Study | COMPLETED | GeneSight Psychotropic Tested | 560 | |
| Overall Study | COMPLETED | Treatment As Usual | 607 | |
| Overall Study | NOT COMPLETED | GeneSight Psychotropic Tested | 121 | |
| Overall Study | NOT COMPLETED | Treatment As Usual | 110 |
Source ClinicalTrials.gov
Adverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | GeneSight Psychotropic Tested | 1 | 681 | 1 |
| serious | Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Treatment As Usual | 0 | 717 | 0 |
| serious | Muscle twitching | Musculoskeletal and connective tissue disorders | GeneSight Psychotropic Tested | 1 | 681 | 1 |
| serious | Muscle twitching | Musculoskeletal and connective tissue disorders | Treatment As Usual | 0 | 717 | 0 |
| serious | Gastrointestinal hemorrhage | Gastrointestinal disorders | GeneSight Psychotropic Tested | 0 | 681 | 0 |
| serious | Gastrointestinal hemorrhage | Gastrointestinal disorders | Treatment As Usual | 1 | 717 | 1 |
| serious | transient hypoglycemia | Metabolism and nutrition disorders | GeneSight Psychotropic Tested | 1 | 681 | 1 |
| serious | transient hypoglycemia | Metabolism and nutrition disorders | Treatment As Usual | 0 | 717 | 0 |
| serious | non cardiac chest pains | General disorders | GeneSight Psychotropic Tested | 0 | 681 | 0 |
| serious | non cardiac chest pains | General disorders | Treatment As Usual | 1 | 717 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | GeneSight Psychotropic Tested | 0 | 681 |
| Total, all-cause mortality | Treatment As Usual | 0 | 717 |
| Total, other adverse events | GeneSight Psychotropic Tested | 0 | 681 |
| Total, other adverse events | Treatment As Usual | 0 | 717 |
| Total, serious adverse events | GeneSight Psychotropic Tested | 3 | 681 |
| Total, serious adverse events | Treatment As Usual | 2 | 717 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| GeneSight Psychotropic Tested vs Treatment As Usual: deaths from any cause | Trial comparisons |
| GeneSight Psychotropic Tested vs Treatment As Usual: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02109939
GET https://conductscience.org/api/trials/v1/NCT02109939/registered?page=2