Back to resultsPharmacogenetics in Primary Care Psychotropics
Primary Purpose
Depression, Obsessive-Compulsive Disorder, Generalized Anxiety Disorder
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Pharmacogenetic testing
Sponsored by
About this trial
This is an interventional treatment trial for Depression
Eligibility Criteria
Inclusion Criteria:
- Over 18
- Prescribed a drug of interest for the first time
Exclusion Criteria:
- Previous pharmacogenetic testing available
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Intervention
Arm Description
Outcomes
Primary Outcome Measures
Patient oriented outcome1- Clinical Improvement
Clinically significant improvement as noted by physician (Subjective and PHQ-9)
Patient oriented outcome2- Adverse effects
Number of patients with specific, common side effects (from medical chart)
Patient oriented outcome3- Time to Improvement
Days to clinical improvement (from medical chart)
Patient oriented outcome5- Visits
Total number of visits to clinic with medication titration required (from medical chart)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03232502
Brief Title
Pharmacogenetics in Primary Care Psychotropics
Official Title
Pharmacogenetics in Primary Care Psychotropics
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 15, 2017 (Anticipated)
Primary Completion Date
January 15, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
Pragmatic trial of pharmacogenetic testing at the time of prescription for a selective serotonin reuptake inhibitor, tricyclic antidepressant or atypical antipsychotic. Does real time intervention improve patient outcomes?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Obsessive-Compulsive Disorder, Generalized Anxiety Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Title
Intervention
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Pharmacogenetic testing
Intervention Description
Basic pharmacogenetic panel
Primary Outcome Measure Information:
Title
Patient oriented outcome1- Clinical Improvement
Description
Clinically significant improvement as noted by physician (Subjective and PHQ-9)
Time Frame
6 months
Title
Patient oriented outcome2- Adverse effects
Description
Number of patients with specific, common side effects (from medical chart)
Time Frame
6 months
Title
Patient oriented outcome3- Time to Improvement
Description
Days to clinical improvement (from medical chart)
Time Frame
Up to 6 months
Title
Patient oriented outcome5- Visits
Description
Total number of visits to clinic with medication titration required (from medical chart)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Over 18
Prescribed a drug of interest for the first time
Exclusion Criteria:
Previous pharmacogenetic testing available
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Pharmacogenetics in Primary Care Psychotropics
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