NCT04469322

Pharmacogenetic Implementation Trial in Veterans With Treatment Refractory Depression

Completed NA Last updated 14 July 2020

What this trial tests

NA trial testing Mental Health DNA Insight Test (Pathway Genomics) in Depression in 182 participants. Completed in 26 June 2018.

Timeline

30 September 2014

Primary endpoint
26 June 2018

26 June 2018

Quick facts

Lead sponsor	San Diego Veterans Healthcare System
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	182
Start date	30 September 2014
Primary completion	26 June 2018
Estimated completion	26 June 2018
Sites	1 location across United States

Drugs / interventions tested

• Mental Health DNA Insight Test (Pathway Genomics)
• Sham Test

Conditions studied

• Depression — all drugs for Depression →
• Depressive Disorder — all drugs for Depressive Disorder →
• Depressive Disorder, Major — all drugs for Depressive Disorder, Major →
• Depression, Bipolar — all drugs for Depression, Bipolar →

Sponsor

San Diego Veterans Healthcare System

Who can join

18 and older, any sex, with Depression or Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Pharmacogenomic Testing and Depressive Symptom Remission: A Systematic Review and Meta-Analysis of Prospective, Controlled Clinical Trials.
   Brown LC, Stanton JD, Bharthi K, Maruf AA, et al · · 2022 · cited 90× · PMID 36111494 · DOI 10.1002/cpt.2748
2. A prospective study to determine the clinical utility of pharmacogenetic testing of veterans with treatment-resistant depression.
   McCarthy MJ, Chen Y, Demodena A, Leckband SG, et al · · 2021 · cited 24× · PMID 33938307 · DOI 10.1177/02698811211015224
3. Effectiveness of pharmacogenomics on the response and remission of treatment-resistant depression: a meta-analysis of randomised controlled trials.
   Cheng Y, Liu H, Yuan R, Yuan K, et al · · 2023 · cited 7× · PMID 38155841 · DOI 10.1136/gpsych-2023-101050