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Evaluation of an Antidepressant Pharmacogenomic Algorithm in an Outpatient Clinical Setting

This study has been completed.
Sponsor:
Collaborator:
Assurex Health Home
Information provided by (Responsible Party):
Daniel K. Hall-Flavin, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01610063
First received: May 25, 2012
Last updated: February 10, 2017
Last verified: February 2017
Results First Received: August 18, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Diagnostic
Condition: Depression
Intervention: Other: Pharmacogenomic algorithm

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was conducted at Franciscan Skemp Hospital in La Crosse, Wisconsin, a member of the Mayo Clinic Health System.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Guided A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing.
Unguided Treatment as usual

Participant Flow:   Overall Study
    Guided   Unguided
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 
Lost to Follow-up                42                20 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Guided A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing.
Unguided Treatment as usual
Total Total of all reporting groups

Baseline Measures
   Guided   Unguided   Total 
Overall Participants Analyzed 
[Units: Participants]
 114   113   227 
Age 
[Units: Years]
Mean (Standard Deviation)
 41.0  (12.8)   44.0  (12.1)   42.62  (12.55) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      69  60.5%      77  68.1%      146  64.3% 
Male      45  39.5%      36  31.9%      81  35.7% 
Region of Enrollment 
[Units: Participants]
     
United States   114   113   227 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage Change in Quick Inventory of Depressive Symptomatology (QIDS-C16) Score From Baseline   [ Time Frame: baseline, 8-week visit ]

2.  Secondary:   Percentage Change in Hamilton Depression Rating Scale (HAMD-17) Score From Baseline   [ Time Frame: baseline, 8-week visit ]

3.  Secondary:   Percentage Change in Patient Health Questionnaire-9 (PHQ-9) Score From Baseline   [ Time Frame: baseline, 8-week visit ]

4.  Secondary:   Percentage Change in Outcome by Bin Status and Treatment Group   [ Time Frame: baseline, 8-week visit ]

5.  Secondary:   Pharmacogenomic Report Utilization   [ Time Frame: baseline, 8-week visit ]

6.  Secondary:   Physicians' Perception of Participant's Satisfaction With Their Care   [ Time Frame: 8-week visit ]

7.  Secondary:   Responders at Week 8   [ Time Frame: baseline, 8 weeks ]

8.  Secondary:   Remitters at Week 8   [ Time Frame: baseline, 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Daniel K. Hall-Flavin
Organization: Mayo Clinic
phone: 507-255-4151
e-mail: flavin.daniel@mayo.edu



Responsible Party: Daniel K. Hall-Flavin, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01610063     History of Changes
Other Study ID Numbers: 08-005610
Study First Received: May 25, 2012
Results First Received: August 18, 2016
Last Updated: February 10, 2017