Pharmacogenetics in Primary Care Psychotropics

Depression Clinical Trial

Official title:

Pharmacogenetics in Primary Care Psychotropics

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03232502
• Other study ID #: Pending1
• Status: Not yet recruiting
• Phase: Phase 3
• First received: July 24, 2017
• Last updated: July 26, 2017
• Start date: August 15, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: July 2017
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: December 31, 2018
• Est. primary completion date: January 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Over 18

• Prescribed a drug of interest for the first time

Exclusion Criteria:

• Previous pharmacogenetic testing available

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Disease
• Generalized Anxiety Disorder
• Obsessive-Compulsive Disorder

Intervention

Diagnostic Test:
• Pharmacogenetic testing
Basic pharmacogenetic panel

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient oriented outcome1- Clinical Improvement	Clinically significant improvement as noted by physician (Subjective and PHQ-9)	6 months
Primary	Patient oriented outcome2- Adverse effects	Number of patients with specific, common side effects (from medical chart)	6 months
Primary	Patient oriented outcome3- Time to Improvement	Days to clinical improvement (from medical chart)	Up to 6 months
Primary	Patient oriented outcome5- Visits	Total number of visits to clinic with medication titration required (from medical chart)	6 months