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NCT02634177 · ClinicalTrials.gov registry record · NA

Genecept Assay™ vs. Treatment-as-Usual to Evaluate Efficacy of Assay-Guided Treatment in Adults With MDD

A NA study of Major Depressive Disorder, sponsored by Genomind.

Completed
Registry status
NA
Development phase
305
Enrollment target
20
Study locations

NCT02634177 is a NA study of Major Depressive Disorder that has completed, run by Genomind. The registered enrollment target is 305 participants, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (19% lower). The trial reports 20 study locations across 12 states.

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The verdict

NCT02634177, a NA study of Major Depressive Disorder, has completed, sponsored by Genomind.

COMPLETED
Registry status
NA
Development phase
305 participants
Enrollment target
20
Study locations

Study Summary

In this randomized clinical trial, subjects will be assigned to either an assay-guided treatment condition (AGT) or a treatment-as-usual condition (TAU). All subjects will provide a DNA sample at the Screening Visit for the Genecept Assay ™. In the AGT condition, assay results will be provided to the treating investigator, who will use the results to guide antidepressant pharmacotherapy. In the TAU condition, the investigator will treat the subjects without the knowledge of the pharmacogenetic testing results. Assay results for all subjects will be provided to the investigator once all Week 8 visit procedures have been completed. Raters of the primary endpoint assessment and subjects will remain blinded to treatment assignment.

Conditions Studied

Interventions

  • OTHER Treatment-as-usual (TAU)
  • GENETIC Assay-guided treatment (AGT)

Study Locations (20)

California

  • Collaborative Neuroscience Network, Inc. - Garden Grove - Garden Grove
  • Pacific Institute of Medical Research - Los Angeles
  • Pacific Research Partners, LLC - Oakland
  • Artemis Institute for Clinical Research - San Diego
  • Collaborative Neuroscience Network, Inc. - Torrance - Torrance
  • Pacific Clinical Research Medical Group - Upland

Florida

  • Florida Clinical Research Center, LLC - Bradenton - Bradenton
  • Clinical Neuroscience Solutions Inc. - Jacksonville - Jacksonville
  • Florida Clinical Research Center, LLC - Maitland - Maitland
  • Clinical Neuroscience Solutions Inc. - Orlando - Orlando

Alabama

  • University of Alabama - Birmingham - Birmingham

Arizona

  • Noesis Pharma - Phoenix

Arkansas

  • Woodland Research Northwest - Springdale

Illinois

  • Chicago Research Center, Inc. - Chicago

Massachusetts

  • Boston Clinical Trials - Boston

Nebraska

  • Premier Psychiatric Research Institute, LLC - Lincoln

Trial Details

FieldValue
Enrollment Target 305 participants
Start Date 2016-01
Est. Completion 2017-07-25
Phase NA

Sponsor

Genomind

3 total trials

What the Registry Record Tells You About NCT02634177

The ClinicalTrials.gov registry entry for NCT02634177 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 305 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (19% lower). The listed sponsor is Genomind, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 2 interventions - of which Treatment-as-usual (TAU) is the first listed.

NCT02634177 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Florida, Alabama.

Frequently Asked Questions

What is clinical trial NCT02634177 about?

NCT02634177 is a clinical study titled "Genecept Assay™ vs. Treatment-as-Usual to Evaluate Efficacy of Assay-Guided Treatment in Adults With MDD". In this randomized clinical trial, subjects will be assigned to either an assay-guided treatment condition (AGT) or a treatment-as-usual condition (TAU). All subjects will provide a DNA sample at the Screening Visit for the Genecept Assay ™. In the AGT condition, assay results will be provided to th...

What is the current status of trial NCT02634177?

This trial is currently completed. It is a NA study. The enrollment target is 305 participants. The study started on 2016-01. Estimated completion is 2017-07-25.

What conditions does trial NCT02634177 study?

This clinical trial studies the following conditions: Major Depressive Disorder.

What interventions are being tested in trial NCT02634177?

The interventions under investigation include: Treatment-as-usual (TAU) (OTHER), Assay-guided treatment (AGT) (GENETIC).

Who is sponsoring clinical trial NCT02634177?

This trial is sponsored by Genomind, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02634177 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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