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Trial record 19 of 1104 for:    pharmacogenomics OR pharmacogenetics

Pharmacogenetics in Primary Care Psychotropics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03232502
Recruitment Status : Unknown
Verified July 2017 by University of Arizona.
Recruitment status was:  Not yet recruiting
First Posted : July 28, 2017
Last Update Posted : July 28, 2017
Information provided by (Responsible Party):
University of Arizona

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?

Condition or disease Intervention/treatment Phase
Depression Obsessive-Compulsive Disorder Generalized Anxiety Disorder Diagnostic Test: Pharmacogenetic testing Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacogenetics in Primary Care Psychotropics
Estimated Study Start Date : August 15, 2017
Estimated Primary Completion Date : January 15, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Control
Experimental: Intervention Diagnostic Test: Pharmacogenetic testing
Basic pharmacogenetic panel

Primary Outcome Measures :
  1. Patient oriented outcome1- Clinical Improvement [ Time Frame: 6 months ]
    Clinically significant improvement as noted by physician (Subjective and PHQ-9)

  2. Patient oriented outcome2- Adverse effects [ Time Frame: 6 months ]
    Number of patients with specific, common side effects (from medical chart)

  3. Patient oriented outcome3- Time to Improvement [ Time Frame: Up to 6 months ]
    Days to clinical improvement (from medical chart)

  4. Patient oriented outcome5- Visits [ Time Frame: 6 months ]
    Total number of visits to clinic with medication titration required (from medical chart)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Over 18
  • Prescribed a drug of interest for the first time

Exclusion Criteria:

  • Previous pharmacogenetic testing available

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Responsible Party: University of Arizona Identifier: NCT03232502     History of Changes
Other Study ID Numbers: Pending1
First Posted: July 28, 2017    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Anxiety Disorders
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Mental Disorders
Personality Disorders
Psychotropic Drugs