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

Completed · Not applicable

Conditions studied: Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT02634177

Run by

Genomind, LLC

People needed

305

Starts

2016-01-01

Expected to finish

2017-07-25

Last updated by the study team

2020-08-28

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18-75 years; Sub-Group Age =/> 65 years
• Ability to understand and provide informed consent
• Ability to understand, read and speak English
• Primary diagnosis of Major Depressive Disorder (without psychosis) based on DSM-5 criteria and MINI 7.0
• SIGH-D-17 score >18 (i.e., moderate depression) at Screening and Baseline
• Failure of at least 1 prior adequate trial of standard antidepressant in the current major depressive episode (using ATRQ criteria - i.e., 6 weeks at adequate dose) due to inefficacy, side effects or intolerability
• Subject is willing to follow study instructions, complete study assessments and likely to complete all required visits

You may not qualify if…

• Severe personality traits (based on DSM-5 criteria) that in the opinion of the investigator may interfere with the participation in the study or the evaluation of efficacy and safety and all diagnosed Personality Disorders
• Current DSM-5 diagnosis of Neurocognitive Disorders, Schizophrenia Spectrum (lifetime diagnosis) and other Psychotic Disorders, Bipolar and Related disorders (lifetime diagnosis*), Trauma and Stress related Disorders, Obsessive Compulsive Disorder and Related Disorders. Other DSM-5 disorders that in the opinion of the investigator may interfere with the participation in the study or the evaluation of efficacy and safety.
• DSM-5 diagnosis of Substance Related and Addictive Disorders diagnosed in the last 12 months (other than tobacco and caffeine)
• History of Suicidal Behavior within 12 months of screening or presence of Active Suicidal Ideation with Intent in the past 12 months (Items 4 or 5) at Screening or Baseline, as determined by the Columbia Suicide Severity Rating Scale (C-SSRS), or subject is considered to be an acute suicide risk in the clinical judgment of the investigator
• Previous homicidal behavior or acute homicidal risk at Screening or Baseline, in the clinical judgment of the investigator
• Four (4) or more failed pharmacologic interventions for depression in the current major depressive episode (One of the four failed interventions must meet ATRQ criteria - i.e., 6 weeks at adequate dose).
• Subjects who are not willing to take psychotropic medications for treatment of MDD.
• Electroconvulsive therapy (ECT) or transcranial magnetic stimulation therapy (TMS) started within 90 days of screening or planned during the study.
• Subjects with a vagus nerve or deep brain stimulator are prohibited from the trial.
• Psychotherapy including cognitive behavioral therapy (CBT), or dialectical behavioral therapy (DBT) started within 90 days of screening or planned during the study.
• Unstable or active medical condition(s) which in the opinion of the investigator would jeopardize the subject's safety or interfere with participation of the study or confound evaluation of efficacy or safety.
• Current diagnosis of unstable hypothyroidism.
• Females who are pregnant, nursing, or planning a pregnancy during the study or believe they may be pregnant at Screening or Baseline.
• Participation in another investigative trial within 30 days of screening
• Subject previously treated with the use of a similar psychotropic genetic testing assay.
• Subject tests positive for illicit drug use on the urine drug screen (UDS) at the screen visit (including Marijuana where legal).

Where it is running

• University of Alabama - Birmingham — Birmingham, Alabama, United States
• Noesis Pharma — Phoenix, Arizona, United States
• Woodland Research Northwest — Springdale, Arkansas, United States
• Collaborative Neuroscience Network, Inc. - Garden Grove — Garden Grove, California, United States
• Pacific Institute of Medical Research — Los Angeles, California, United States
• Pacific Research Partners, LLC — Oakland, California, United States
• Artemis Institute for Clinical Research — San Diego, California, United States
• Collaborative Neuroscience Network, Inc. - Torrance — Torrance, California, United States
• Pacific Clinical Research Medical Group — Upland, California, United States
• Florida Clinical Research Center, LLC - Bradenton — Bradenton, Florida, United States
• Clinical Neuroscience Solutions Inc. - Jacksonville — Jacksonville, Florida, United States
• Florida Clinical Research Center, LLC - Maitland — Maitland, Florida, United States
• Clinical Neuroscience Solutions Inc. - Orlando — Orlando, Florida, United States
• Chicago Research Center, Inc. — Chicago, Illinois, United States
• Boston Clinical Trials — Boston, Massachusetts, United States
• Premier Psychiatric Research Institute, LLC — Lincoln, Nebraska, United States
• Richard H Weisler MD, PA and Associates — Raleigh, North Carolina, United States
• Midwest Clinical Research Center — Dayton, Ohio, United States
• IPS Research Company — Oklahoma City, Oklahoma, United States
• Thomas Jefferson University Mood Disorder Program — Philadelphia, Pennsylvania, United States
• Clinical Neuroscience Solutions Inc. - Memphis — Memphis, Tennessee, United States
• BioBehavioral Research of Austin, PC — Austin, Texas, United States
• University of Virginia Center for Psychiatric Research — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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