Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
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.
 
ClinicalTrials.gov 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
Sponsor:
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

Layout table for study information
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

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

Exclusion Criteria:

  • Previous pharmacogenetic testing available

Layout table for additonal information
Responsible Party: University of Arizona
ClinicalTrials.gov 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

Layout table for additional information
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:
Layout table for MeSH terms
Disease
Anxiety Disorders
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Mental Disorders
Personality Disorders
Psychotropic Drugs