An interventional study of Genecept Assay in Major Depressive Disorder, sponsored by Genomind, LLC. Terminated at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-09-13.
Sponsored by Genomind, LLC · Not applicable, Interventional, and Other
One-third or more of individuals treated for major depressive disorder (MDD) do not experience remission of symptoms despite at least two adequate antidepressant trials. Such treatment-resistant depression (TRD) contributes disproportionately to the tremendous costs of MDD, in terms of health care costs, functional impairment, and diminished quality of life.
The promise of personalized medicine for individuals at high risk for TRD is apparent. If these individuals could be recognized early in their disease course, they could be triaged to more intensive or targeted interventions to improve their likelihood of remission. With the proliferation of treatment options in MDD, at present individuals can spend months or years in and out of treatment before receiving these next-step treatments.
At present, no clinical or biomarker-based tool has been shown to assist in matching patients with treatments most likely to be effective for them. The Genecept Assay offers the possibility of "Personalized Medicine" in psychiatry. Clinicians may find this additional genetic information can lead to optimized treatment plans for individual patients. Before such an assay can be widely applied clinically, it is necessary to demonstrate that this tool usefully impacts treatment outcomes.
This study will examine the potential impact of the assay in terms of depression severity at 3 months, with further follow-up out to 6 months. Secondary measures will allow an estimate of its potential to change clinician behavior and improve patient quality of life. Further measures will also allow for refinement of the assay to maximize patient and clinician satisfaction, and estimate the potential savings associated with deployment of this assay in real-world clinical settings.
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's enrollment of 29 is below the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →Genomind, LLC is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects will give DNA sample for genetic testing but will not receive genetic results and will therefore receive treatment as usual.
Subjects donate DNA sample for genetic testing and treatment decisions take genetic results into account.
Device: Genecept Assay
Genetic test which analyzes five pharmacodynamic and two pharmacokinetic genes important in psychiatric disorders
Also known as: Genetic Test
Efficacy Measured by Change in Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR), Adjusted for Baseline Severity, at 6 Months
To determine the efficacy of assay-guided treatment (AGT) versus treatment-as-usual (TAU), in terms of depression severity as measured by change in Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR), adjusted for baseline severity, at 6 months Add: * highest score on any 1 of the 4 sleep items (items 1 to 4) * highest score on any 1 of the 4 weight items (items 6 to 9) * highest score on either of the 2 psychomotor items (15 and 16) * scores for each of the 6 MDD symptom domains Total scores range from 0-27. 0 = no signs of depression; 27 = severe depression
Time frame: 6 months
Clinician Behavior as Measured by Change in Recorded Treatment Choice Before and After the Assay Results Are Made Available.
Clinicians will rank first and alternative treatment choice and dosage prior to assay and first and two alternative treatment choices after receiving assay results (for AGT group). Clinician choices will be compared.
Time frame: one week
Quality of Life as Measured by Self Reported Assessment of Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)
To determine the efficacy of assay-guided treatment (AGT) versus treatment-as-usual (TAU) in outpatient treatment of nonpsychotic major depressive disorder, in terms of patient quality of life (Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)) The minimum raw score on the QLESQ is 14, and the maximum score is 70.
Time frame: baseline, 3, 6 months
Cost
To compare costs of AGT versus TAU in outpatient treatment of nonpsychotic major depressive disorder as measured by claims data.
Time frame: 6 months
Acceptability of the Use of AGT for Subjects and Clinicians as Measured by Satisfaction Survey
To determine the acceptability to patients and clinicians of assay-guided treatment (AGT) versus treatment-as-usual (TAU) in outpatient treatment of nonpsychotic major depressive disorder
Time frame: 6 months
| Milestone | Treatment as Usual (TAU) | Genecept Assay |
|---|---|---|
| Started | 12 | 17 |
| Completed | 12 | 17 |
| Not completed | 0 | 0 |
To determine the efficacy of assay-guided treatment (AGT) versus treatment-as-usual (TAU), in terms of depression severity as measured by change in Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR), adjusted for baseline severity, at 6 months Add: * highest score on any 1 of the 4 sleep items (items 1 to 4) * highest score on any 1 of the 4 weight items (items 6 to 9) * highest score on either of the 2 psychomotor items (15 and 16) * scores for each of the 6 MDD symptom domains Total scores range from 0-27. 0 = no signs of depression; 27 = severe depression
No measurements were reported for this outcome.
Clinicians will rank first and alternative treatment choice and dosage prior to assay and first and two alternative treatment choices after receiving assay results (for AGT group). Clinician choices will be compared.
No measurements were reported for this outcome.
To determine the efficacy of assay-guided treatment (AGT) versus treatment-as-usual (TAU) in outpatient treatment of nonpsychotic major depressive disorder, in terms of patient quality of life (Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)) The minimum raw score on the QLESQ is 14, and the maximum score is 70.
No measurements were reported for this outcome.
To compare costs of AGT versus TAU in outpatient treatment of nonpsychotic major depressive disorder as measured by claims data.
No measurements were reported for this outcome.
To determine the acceptability to patients and clinicians of assay-guided treatment (AGT) versus treatment-as-usual (TAU) in outpatient treatment of nonpsychotic major depressive disorder
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment as Usual (TAU) | — | 0/12 (0%) | 3/12 (25%) |
| Genecept Assay | — | 0/17 (0%) | 6/17 (35.3%) |
| Event | Treatment as Usual (TAU) | Genecept Assay |
|---|---|---|
| Minor to Moderate Adverse Effects to MedicationsPsychiatric disorders | 3/12 | 6/17 |
| Age, Categorical(Participants) | Treatment as Usual (TAU) | Genecept Assay | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 12 | 17 | 29 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(Years) | Treatment as Usual (TAU) | Genecept Assay | Total |
|---|---|---|---|
| Mean | 44 (24 to 59) | 46 (23 to 65) | 45 (23 to 65) |
| Sex: Female, Male(Participants) | Treatment as Usual (TAU) | Genecept Assay | Total |
|---|---|---|---|
| Female | 11 | 11 | 22 |
| Male | 1 | 6 | 7 |
| Ethnicity (NIH/OMB)(Participants) | Treatment as Usual (TAU) | Genecept Assay | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 11 | 17 | 28 |
| Unknown or Not Reported | 0 | 0 | 0 |
This study is terminated, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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