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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: Completed NA study of Major Depressive Disorder, sponsored by Genomind.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
SIGH-D-17: 17-item rater-administered Structured Interview Guide of the Hamilton Depression Rating Scale Scoring is based on the 17-item scale and scores range from 0 minimum to 52 maximum. Scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression; the maximum score being 52 on the 17-point scale.
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
| Field | Value |
|---|---|
| Enrollment Target | 305 participants |
| Start Date | 2016-01 |
| Est. Completion | 2017-07-25 |
| Phase | NA |
What the finished NCT02634177 record still lists
NCT02634177 is an interventional study that assigns participants to a tested intervention. The registered 305 participants enrollment target is mid-sized for trials with a published cap, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (19% lower).
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 names 20 study sites across 12 states, led by 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.
Learn More About Clinical Trials
Similar trials for Major Depressive Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02634177's enrollment target sits among peer trials
305 54th of 282 higher than 229 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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