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Evaluation of an Antidepressant Pharmacogenomic Algorithm in an Outpatient Clinical Setting

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ClinicalTrials.gov Identifier: NCT01610063
Recruitment Status : Completed
First Posted : June 1, 2012
Results First Posted : March 30, 2017
Last Update Posted : March 30, 2017
Sponsor:
Collaborator:
Assurex Health Home
Information provided by (Responsible Party):
Daniel K. Hall-Flavin, Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Depression
Intervention Other: Pharmacogenomic algorithm
Enrollment 227
Recruitment Details This study was conducted at Franciscan Skemp Hospital in La Crosse, Wisconsin, a member of the Mayo Clinic Health System.
Pre-assignment Details 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.
Arm/Group Title Guided Unguided
Hide Arm/Group Description A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing. Treatment as usual
Period Title: Overall Study
Started 114 113
Baseline 114 113
Completed 2-week 97 105
Completed 4-week 86 98
Completed 8-week 72 93
Completed 72 93
Not Completed 42 20
Reason Not Completed
Lost to Follow-up             42             20
Arm/Group Title Guided Unguided Total
Hide Arm/Group Description A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing. Treatment as usual Total of all reporting groups
Overall Number of Baseline Participants 114 113 227
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 114 participants 113 participants 227 participants
41.0  (12.8) 44.0  (12.1) 42.62  (12.55)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 114 participants 113 participants 227 participants
Female
69
  60.5%
77
  68.1%
146
  64.3%
Male
45
  39.5%
36
  31.9%
81
  35.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 114 participants 113 participants 227 participants
114 113 227
1.Primary Outcome
Title Percentage Change in Quick Inventory of Depressive Symptomatology (QIDS-C16) Score From Baseline
Hide Description 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.
Time Frame baseline, 8-week visit
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Guided Unguided
Hide Arm/Group Description:
A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing.
Treatment as usual
Overall Number of Participants Analyzed 72 93
Mean (Standard Deviation)
Unit of Measure: Percentage change in depression rating
Subjects in red category (n=16, 18) -41.2  (31.7) -11.0  (31.9)
Subjects in green/yellow category (n=48, 63) -48.4  (28.1) -31.8  (29.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Guided, Unguided
Comments Comparison for QIDS-C16
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Percentage Change in Hamilton Depression Rating Scale (HAMD-17) Score From Baseline
Hide Description 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.
Time Frame baseline, 8-week visit
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Guided Unguided
Hide Arm/Group Description:
A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing.
Treatment as usual
Overall Number of Participants Analyzed 72 93
Mean (Standard Deviation)
Unit of Measure: Percentage change in depression rating
Subjects in red category (n=16, 18) -42.2  (24.8) -15.0  (20.9)
Subjects in green or yellow category (n=48, 63) -49.5  (28.4) -35.6  (31.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Guided, Unguided
Comments Comparison between groups for HAMD-17
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Percentage Change in Patient Health Questionnaire-9 (PHQ-9) Score From Baseline
Hide Description 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.
Time Frame baseline, 8-week visit
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Guided Unguided
Hide Arm/Group Description:
A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing.
Treatment as usual
Overall Number of Participants Analyzed 72 93
Mean (Standard Deviation)
Unit of Measure: Percentage change in depression rating
Subjects in red category (n=16, 18) -46.3  (35.8) -15.5  (31.4)
Subjects in green/yellow category (n=47, 63) -44.0  (39.9) -20.7  (63.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Guided, Unguided
Comments Comparison for PHQ-9
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Percentage Change in Outcome by Bin Status and Treatment Group
Hide Description 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.
Time Frame baseline, 8-week visit
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Guided Unguided
Hide Arm/Group Description:
A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing.
Treatment as usual
Overall Number of Participants Analyzed 72 93
Mean (Standard Deviation)
Unit of Measure: Percentage change
%Change in HAMD-17 score, red (n=16, 18) -42.2  (24.8) -15.0  (20.9)
%Change in HAMD-17 score, green/yellow (n=48,63) -49.5  (28.4) -35.6  (31.7)
%Change in QIDS-C16 score, red (n=16,18) -41.2  (31.7) -11  (31.9)
%Change in QIDS-C16 score green/yellow (n=48,63) -48.4  (28.1) -31.8  (29.8)
%Change in PHQ-9 score, red (n=16,18) -46.3  (35.8) -15.5  (31.4)
%Change in PHQ-9 score, green/yellow (n=47,63) -44.0  (39.9) -20.7  (63.9)
5.Secondary Outcome
Title Pharmacogenomic Report Utilization
Hide Description Physicians were directed to complete a survey for each participant detailing their experiences during the study period.
Time Frame baseline, 8-week visit
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Guided Unguided
Hide Arm/Group Description:
A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing.
Treatment as usual
Overall Number of Participants Analyzed 72 93
Measure Type: Number
Unit of Measure: percentage of participants
Overall med/dose changes (n=72, 93) 76.8 44.1
Med/dose changes in red bin subjects (n=16, 18) 93.8 55.6
6.Secondary Outcome
Title Physicians' Perception of Participant's Satisfaction With Their Care
Hide Description 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.
Time Frame 8-week visit
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Guided Unguided
Hide Arm/Group Description:
A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing.
Treatment as usual
Overall Number of Participants Analyzed 37 89
Measure Type: Number
Unit of Measure: percentage of physicians
Very high patient satisfaction (n=37,88) 40.5 14.8
Physicians satisfied with care (n=37,89) 94.6 61.8
Very confident/confident med selection (n=37,89) 91.9 61.8
7.Secondary Outcome
Title Responders at Week 8
Hide Description 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.
Time Frame baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Guided Unguided
Hide Arm/Group Description:
A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing.
Treatment as usual
Overall Number of Participants Analyzed 114 113
Measure Type: Number
Unit of Measure: percentage of participants
HAMD-17 43.1 26.9
PHQ-9 50.7 31.2
QIDS-C16 44.4 23.7
8.Secondary Outcome
Title Remitters at Week 8
Hide Description 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).
Time Frame baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Guided Unguided
Hide Arm/Group Description:
A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing.
Treatment as usual
Overall Number of Participants Analyzed 114 113
Measure Type: Number
Unit of Measure: percentage of participants
HAMD-17 30.6 21.5
PHQ-9 25.4 16.1
QIDS-C16 26.4 12.9
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Guided Unguided
Hide Arm/Group Description A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing. Treatment as usual
All-Cause Mortality
Guided Unguided
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Guided Unguided
Affected / at Risk (%) Affected / at Risk (%)
Total   0/114 (0.00%)   0/113 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Guided Unguided
Affected / at Risk (%) Affected / at Risk (%)
Total   0/114 (0.00%)   0/113 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Daniel K. Hall-Flavin
Organization: Mayo Clinic
Phone: 507-255-4151
EMail: flavin.daniel@mayo.edu
Layout table for additonal information
Responsible Party: Daniel K. Hall-Flavin, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01610063     History of Changes
Other Study ID Numbers: 08-005610
First Submitted: May 25, 2012
First Posted: June 1, 2012
Results First Submitted: August 18, 2016
Results First Posted: March 30, 2017
Last Update Posted: March 30, 2017