NCT03232502

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?

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P25-P50 for phase_3 depression

Timeline
Completed

Started Aug 2017

Shorter than P25 for phase_3 depression

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 28, 2017

Completed
18 days until next milestone

Study Start

First participant enrolled

August 15, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2018

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

July 28, 2017

Status Verified

July 1, 2017

Enrollment Period

5 months

First QC Date

July 24, 2017

Last Update Submit

July 26, 2017

Conditions

DepressionObsessive-Compulsive DisorderGeneralized Anxiety Disorder

Outcome Measures

Primary Outcomes (4)

  • Patient oriented outcome1- Clinical Improvement

    Clinically significant improvement as noted by physician (Subjective and PHQ-9)

    6 months

  • Patient oriented outcome2- Adverse effects

    Number of patients with specific, common side effects (from medical chart)

    6 months

  • Patient oriented outcome3- Time to Improvement

    Days to clinical improvement (from medical chart)

    Up to 6 months

  • Patient oriented outcome5- Visits

    Total number of visits to clinic with medication titration required (from medical chart)

    6 months

Study Arms (2)

Control

NO INTERVENTION

Intervention

EXPERIMENTAL
Diagnostic Test: Pharmacogenetic testing

Interventions

Pharmacogenetic testingDIAGNOSTIC_TEST

Basic pharmacogenetic panel

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Previous pharmacogenetic testing available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

DepressionObsessive-Compulsive DisorderGeneralized Anxiety Disorder

Interventions

Pharmacogenomic Testing

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorAnxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Genetic TestingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesGenetic TechniquesGenetic ServicesHealth ServicesHealth Care Facilities Workforce and ServicesDiagnostic ServicesPreventive Health Services

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2017

First Posted

July 28, 2017

Study Start

August 15, 2017

Primary Completion

January 15, 2018

Study Completion

December 31, 2018

Last Updated

July 28, 2017

Record last verified: 2017-07