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| Name | Class |
|---|---|
| Assurex Health Home | INDUSTRY |
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This was a study of a genotyping tool that reported on how subjects responded to medications and could be used in a community psychiatry practice to improve medication choice for depression. After the DNA test, an interpretive report was provided to the subjects' physicians. The hypothesis of this pilot study was that it was feasible to use this pharmacogenomic algorithm in a new setting to treat depressed subjects..
Antidepressant medications are among the most widely prescribed medications. However, only 35% to 45% of depressed patients have a complete remission of their illness when initially treated with these medications. Consequently, the Mayo Clinic psychiatric pharmacogenomic team developed a pharmacogenomic algorithm designed to improve the effectiveness and safety of antidepressant medications by providing guidance in medication selection and appropriate dosing. This algorithm has been incorporated into a new genotyping interpretative report. The pharmacogenomic algorithm is based on genotyping both copies of four informative genes. These four genes are: 1) the Cytochrome (P450 2D6) gene; 2) the Cytochrome (P450 2C19) gene; 3) the Serotonin Transporter gene (SLC6A4); and 4) the Serotonin 2A receptor gene (5HTR2A). The trial took place at the Franciscan Skemp Healthcare System in La Crosse, Wisconsin over the course of 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Guided | Experimental | A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing. |
|
| Unguided | No Intervention | Treatment as usual |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmacogenomic algorithm | Other | Genetic test results for 4 genes were put through algorithm and provided to physician for guidance prescribing medication. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change in Quick Inventory of Depressive Symptomatology (QIDS-C16) Score From Baseline | The QIDS-C16 is a 16-item scale that is clinician-rated; it is designed to assess the severity of depressive symptoms. The QIDS-C16 total score ranges from 0-27. Scores ranging from 0 to 10 correspond with no to mild depression, while scores >/= 11 correspond to moderate to severe depression. A negative change indicates improvement in the subject's depression, and a positive change indicates a worsening of the subject's depression. | baseline, 8-week visit |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change in Hamilton Depression Rating Scale (HAMD-17) Score From Baseline | The HAMD-17 is a 17-item scale that evaluates depressed mood, vegetative and cognitive symptoms of depression, and co-morbid anxiety symptoms. The 17 items are rated on either a 5-point (0-4) or a 3-point (0-2) scale. In general, the 5 point scale items use a rating of 0=absent; 1=doubtful to mild; 2=mild to moderate; 3=moderate to severe; 4=very severe. The 3-point scale items use a rating of 0=absent; 1=probable or mild; 2=definite. The total HAMD-17 score ranges from 0 (not ill) to 52 (severely ill). A negative change indicates improvement in the subject's depression/anxiety symptoms, and a positive change indicates a worsening of the subject's depression/anxiety symptoms. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel K. Hall-Flavin | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Franciscan Skemp HealthCare | La Crosse | Wisconsin | 54601 | United States |
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233 male and female patients between the ages of 18 and 80 years with a primary DSM-IV diagnosis of major depressive disorder or depressive disorder not otherwise specified (NOS) were approached for consent. 3 patients refused consent. 3 participants failed to meet eligibility criteria.
This study was conducted at Franciscan Skemp Hospital in La Crosse, Wisconsin, a member of the Mayo Clinic Health System.
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| ID | Title | Description |
|---|---|---|
| FG000 | Guided | A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing. |
| FG001 | Unguided | Treatment as usual |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Guided | A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing. |
| BG001 | Unguided | Treatment as usual |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage Change in Quick Inventory of Depressive Symptomatology (QIDS-C16) Score From Baseline | The QIDS-C16 is a 16-item scale that is clinician-rated; it is designed to assess the severity of depressive symptoms. The QIDS-C16 total score ranges from 0-27. Scores ranging from 0 to 10 correspond with no to mild depression, while scores >/= 11 correspond to moderate to severe depression. A negative change indicates improvement in the subject's depression, and a positive change indicates a worsening of the subject's depression. | This analysis was performed on subjects who completed the study. There were 8 out of 72 patients in the guided arm and 12 out of 93 patients in the unguided arm who did not have assigned medication color in green/yellow/red. The number analyzed per row is indicated as (n=guided,unguided). | Posted | Mean | Standard Deviation | Percentage change in depression rating | baseline, 8-week visit |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Guided | A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel K. Hall-Flavin | Mayo Clinic | 507-255-4151 | flavin.daniel@mayo.edu |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| baseline, 8-week visit |
| Percentage Change in Patient Health Questionnaire-9 (PHQ-9) Score From Baseline | The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire. The PHQ-9 is based directly on the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Fourth Edition (DSM-IV). Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 27 (severe symptoms) for depression. A negative change indicates improvement in the subject's depression symptoms, and a positive change indicates a worsening of the subject's depression symptoms. | baseline, 8-week visit |
| Percentage Change in Outcome by Bin Status and Treatment Group | The Genesight algorithm presents recommendations for antidepressants and antipsychotics in "bin status" associated with colors. Green indicates "Use as Directed." Yellow indicates "Use with Caution." Red indicates "Use with Increased Caution and with More Frequent Monitoring." Definitions of the depression questionnaires are found in previous outcome measures. A negative change indicates improvement in the subject's depression/anxiety symptoms, and a positive change indicates a worsening of the subject's depression/anxiety symptoms. | baseline, 8-week visit |
| Pharmacogenomic Report Utilization | Physicians were directed to complete a survey for each participant detailing their experiences during the study period. | baseline, 8-week visit |
| Physicians' Perception of Participant's Satisfaction With Their Care | Physicians reported on their perception of each participant's satisfaction with their care only for patients who completed the 8-week study. Physicians were directed to complete a survey for each participant detaining their experience during the study period. | 8-week visit |
| Responders at Week 8 | Definitions of the depression questionnaires are found in previous outcome measures. Definition of responder: a participant who had 50% or higher reduction in psychiatric score from baseline. | baseline, 8 weeks |
| Remitters at Week 8 | Definitions of the depression questionnaires are found in previous outcome measures. Definition of remitter: a participant with score less than or equal to certain value (HAMD-17 <=7, QIDS-C16<=5, PHQ-9<5). | baseline, 8 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing.
| OG001 | Unguided | Treatment as usual |
|
|
|
| Secondary | Percentage Change in Hamilton Depression Rating Scale (HAMD-17) Score From Baseline | The HAMD-17 is a 17-item scale that evaluates depressed mood, vegetative and cognitive symptoms of depression, and co-morbid anxiety symptoms. The 17 items are rated on either a 5-point (0-4) or a 3-point (0-2) scale. In general, the 5 point scale items use a rating of 0=absent; 1=doubtful to mild; 2=mild to moderate; 3=moderate to severe; 4=very severe. The 3-point scale items use a rating of 0=absent; 1=probable or mild; 2=definite. The total HAMD-17 score ranges from 0 (not ill) to 52 (severely ill). A negative change indicates improvement in the subject's depression/anxiety symptoms, and a positive change indicates a worsening of the subject's depression/anxiety symptoms. | This analysis was performed on subjects who completed the study. There were 8 out of 72 patients in the guided arm and 12 out of 93 patients in the unguided arm who did not have assigned medication color in green/yellow/red. The number analyzed per row is indicated as (n=guided,unguided). | Posted | Mean | Standard Deviation | Percentage change in depression rating | baseline, 8-week visit |
|
|
|
|
| Secondary | Percentage Change in Patient Health Questionnaire-9 (PHQ-9) Score From Baseline | The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire. The PHQ-9 is based directly on the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Fourth Edition (DSM-IV). Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 27 (severe symptoms) for depression. A negative change indicates improvement in the subject's depression symptoms, and a positive change indicates a worsening of the subject's depression symptoms. | There were 8 out of 72 patients in the guided arm and 12 out of 93 patients in the unguided arm who did not have assigned medication color in green/yellow/red. The number analyzed per row is indicated as (n=guided,unguided). One subject in the guided arm (green/yellow) did not complete the PHQ-9 questionnaire at 8 weeks. | Posted | Mean | Standard Deviation | Percentage change in depression rating | baseline, 8-week visit |
|
|
|
|
| Secondary | Percentage Change in Outcome by Bin Status and Treatment Group | The Genesight algorithm presents recommendations for antidepressants and antipsychotics in "bin status" associated with colors. Green indicates "Use as Directed." Yellow indicates "Use with Caution." Red indicates "Use with Increased Caution and with More Frequent Monitoring." Definitions of the depression questionnaires are found in previous outcome measures. A negative change indicates improvement in the subject's depression/anxiety symptoms, and a positive change indicates a worsening of the subject's depression/anxiety symptoms. | All subjects were evaluated for a bin status, but not all the arms had subjects assigned to every bin status (green, yellow, or red). Bin status for each category title is reported as (n=Guided, Unguided). | Posted | Mean | Standard Deviation | Percentage change | baseline, 8-week visit |
|
|
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| Secondary | Pharmacogenomic Report Utilization | Physicians were directed to complete a survey for each participant detailing their experiences during the study period. | The medication changes of patients were recorded only for patients who completed the 8-week study (n=72,93 for guided and unguided arms). For each row below, the number of subjects analyzed is indicated by (n=guided, unguided) arms. | Posted | Number | percentage of participants | baseline, 8-week visit |
|
|
|
| Secondary | Physicians' Perception of Participant's Satisfaction With Their Care | Physicians reported on their perception of each participant's satisfaction with their care only for patients who completed the 8-week study. Physicians were directed to complete a survey for each participant detaining their experience during the study period. | Physicians completed surveys for 89 participants (96%) from the unguided group, and for 37 participants (51.4%) from the guided group. For each row below, the number of subjects analyzed is indicated by (n=guided, unguided) arms. For the first row, one of the physicians who completed the survey did not answer this question. | Posted | Number | percentage of physicians | 8-week visit |
|
|
|
| Secondary | Responders at Week 8 | Definitions of the depression questionnaires are found in previous outcome measures. Definition of responder: a participant who had 50% or higher reduction in psychiatric score from baseline. | Posted | Number | percentage of participants | baseline, 8 weeks |
|
|
|
| Secondary | Remitters at Week 8 | Definitions of the depression questionnaires are found in previous outcome measures. Definition of remitter: a participant with score less than or equal to certain value (HAMD-17 <=7, QIDS-C16<=5, PHQ-9<5). | Posted | Number | percentage of participants | baseline, 8 weeks |
|
|
|
| 0 |
| 114 |
| 0 |
| 114 |
| EG001 | Unguided | Treatment as usual | 0 | 113 | 0 | 113 |
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| %Change in QIDS-C16 score, red (n=16,18) |
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| %Change in QIDS-C16 score green/yellow (n=48,63) |
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| %Change in PHQ-9 score, red (n=16,18) |
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| %Change in PHQ-9 score, green/yellow (n=47,63) |
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| Very confident/confident med selection (n=37,89) |
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| QIDS-C16 |
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| QIDS-C16 |
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