NCT04469322

Brief Summary

Many patients with depression do not respond well to medication and are diagnosed with treatment refractory depression (TRD). Sometimes medications don't work because an individual metabolizes the drugs in an atypical manner (too fast/slow). Alternatively, drugs may fail to work because the underlying sub-type of depression is not effectively targeted by a medication. This study will use genetic testing of subjects with TRD to personalize the drug treatment of depression and guide the patient to a better clinical outcome. In the guided group, the clinician will receive a pharmacogenetic report to help individually tailor medication selection for TRD patients, potentially allowing the clinician to pick more effective medications right away, and when necessary, use drug combinations that are well-tolerated and less likely to cause unwanted side effects. The control group will receive a sham genetic report and be treated according to typical standards of care. The investigators will conduct our study in a "real world" setting, with few restrictions on which TRD patients can participate. In this way, the findings may be more likely to reveal how useful genetic testing will be when applied more broadly in psychiatry.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
182

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Sep 2014

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

September 30, 2014

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2018

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 14, 2020

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

3.7 years

First QC Date

July 3, 2020

Last Update Submit

July 8, 2020

Conditions

DepressionDepressive DisorderDepressive Disorder, MajorDepression, BipolarDepressive Episode

Keywords

pharmacogeneticpharmacogenomicgenetics

Outcome Measures

Primary Outcomes (1)

  • Clinical Global Impression (CGI)

    Observer rated 7 item scale indicating overall clinical severity of depression (1 asymptomatic - 7 severe)

    8 weeks

Secondary Outcomes (8)

  • Clinical Global Impression (CGI)

    0 weeks

  • Clinical Global Impression (CGI)

    4 weeks

  • Side Effects Burden

    0 weeks

  • Side Effects Burden

    4 weeks

  • Side Effects Burden

    8 weeks

  • +3 more secondary outcomes

Study Arms (2)

Pharmacogenetic Test Guided

EXPERIMENTAL

Treating physician for this group receives a detailed pharmacogenetic report for the patient, prioritizing 53 psychoactive medications into 4 use categories: preferential use, use as directed, may have significant limitations, and may have severe adverse reactions.

Diagnostic Test: Mental Health DNA Insight Test (Pathway Genomics)

Treatment As Usual

SHAM COMPARATOR

Treating physician receives a sham report listing the names of all drugs and treats patients according to standard of care.

Diagnostic Test: Sham Test

Interventions

Mental Health DNA Insight Test (Pathway Genomics)DIAGNOSTIC_TEST

Pharmacogenetic report based on the patients DNA profile at \~45 SNP markers covering 16 genes

Pharmacogenetic Test Guided
Sham TestDIAGNOSTIC_TEST

Names of 53 medications listed with "use as directed"

Treatment As Usual

Eligibility Criteria

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

You may qualify if:

  • Age \>18
  • Veteran
  • Psychiatric diagnosis
  • Clinically significant depressive symptoms
  • Failed 1 or more adequate treatment trials

You may not qualify if:

  • No clinically significant symptoms of depression
  • No previous medication trials
  • Pregnancy
  • Inpatient medical or psychiatric hospitalization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA San Diego Healthcare System

San Diego, California, 92161, United States

Location

Related Publications (1)

  • McCarthy MJ, Chen Y, Demodena A, Leckband SG, Fischer E, Golshan S, Suppes T, Kelsoe JR. A prospective study to determine the clinical utility of pharmacogenetic testing of veterans with treatment-resistant depression. J Psychopharmacol. 2021 Aug;35(8):992-1002. doi: 10.1177/02698811211015224. Epub 2021 May 3.

    PMID: 33938307DERIVED

MeSH Terms

Conditions

DepressionDepressive DisorderDepressive Disorder, MajorBipolar Disorder

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMood DisordersMental DisordersBipolar and Related Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
patient blinded to condition
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized, single blind, multi-center, prospective
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Psychiatrist

Study Record Dates

First Submitted

July 3, 2020

First Posted

July 14, 2020

Study Start

September 30, 2014

Primary Completion

June 26, 2018

Study Completion

June 26, 2018

Last Updated

July 14, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)