NCT01610063

Brief Summary

This was a study of a genotyping tool that reported on how subjects responded to medications and could be used in a community psychiatry practice to improve medication choice for depression. After the DNA test, an interpretive report was provided to the subjects' physicians. The hypothesis of this pilot study was that it was feasible to use this pharmacogenomic algorithm in a new setting to treat depressed subjects..

Trial Health

87
On Track

Trial Health Score

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

Enrollment
227

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 1, 2012

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

March 30, 2017

Completed
Last Updated

March 30, 2017

Status Verified

February 1, 2017

Enrollment Period

2.8 years

First QC Date

May 25, 2012

Results QC Date

August 18, 2016

Last Update Submit

February 10, 2017

Conditions

Depression

Keywords

AlgorithmDepressionAssurexGeneSight

Outcome Measures

Primary Outcomes (1)

  • Percentage Change in Quick Inventory of Depressive Symptomatology (QIDS-C16) Score From Baseline

    The QIDS-C16 is a 16-item scale that is clinician-rated; it is designed to assess the severity of depressive symptoms. The QIDS-C16 total score ranges from 0-27. Scores ranging from 0 to 10 correspond with no to mild depression, while scores \>/= 11 correspond to moderate to severe depression. A negative change indicates improvement in the subject's depression, and a positive change indicates a worsening of the subject's depression.

    baseline, 8-week visit

Secondary Outcomes (7)

  • Percentage Change in Hamilton Depression Rating Scale (HAMD-17) Score From Baseline

    baseline, 8-week visit

  • Percentage Change in Patient Health Questionnaire-9 (PHQ-9) Score From Baseline

    baseline, 8-week visit

  • Percentage Change in Outcome by Bin Status and Treatment Group

    baseline, 8-week visit

  • Pharmacogenomic Report Utilization

    baseline, 8-week visit

  • Physicians' Perception of Participant's Satisfaction With Their Care

    8-week visit

  • +2 more secondary outcomes

Study Arms (2)

Guided

EXPERIMENTAL

A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing.

Other: Pharmacogenomic algorithm

Unguided

NO INTERVENTION

Treatment as usual

Interventions

Pharmacogenomic algorithmOTHER

Genetic test results for 4 genes were put through algorithm and provided to physician for guidance prescribing medication.

Also known as: GeneSight
Guided

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient is between the ages of 18 and 80.
  • Major depressive disorder or depressive disorder not otherwise specified as ascertained by a physician or mental health professional licensed to diagnose.
  • Patient is an outpatient and not in imminent need of inpatient hospitalization, or a discharging inpatient with scheduled follow-up with a Behavioral Health psychiatrist.
  • Patient has been referred to see a psychiatrist for optimum medication management.
  • Patient's Hamilton Depression Rating score is \>14
  • Ability to read, understand and sign an informed consent document

You may not qualify if:

  • Serious medical illness (as ascertained via the initial triage screening process)
  • Patients with a diagnosis of Bipolar I disorder
  • Patients with a diagnosis of Schizophrenia or Schizoaffective disorder
  • Patients who are legally unable to consent to enrollment in the study (i.e. patients with legal guardians)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Franciscan Skemp HealthCare

La Crosse, Wisconsin, 54601, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Results Point of Contact

Title
Dr. Daniel K. Hall-Flavin
Organization
Mayo Clinic
flavin.daniel@mayo.edu
507-255-4151

Study Officials

  • Daniel K. Hall-Flavin

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

May 25, 2012

First Posted

June 1, 2012

Study Start

January 1, 2009

Primary Completion

November 1, 2011

Study Completion

May 1, 2013

Last Updated

March 30, 2017

Results First Posted

March 30, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)