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

NCT02634177 | Completed Results

• 1 other identifier: GNM-PROT MDD-01
• Study Type: interventional
• Target: 305
• Locations: 1 country
• Sites: 23

Brief 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

Major Depressive Disorder

Keywords

Genotyping; Genecept Assay™

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in SIGH-D-17 Score at 8 Weeks.

  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.

  Baseline to 8 Weeks

Secondary Outcomes (8)

• Mean Change From Baseline in QIDS-SR16 Score at 8 Weeks.

  Baseline to 8 Weeks

• Percentage of Treatment Responders at Week 8 Based on ≥ 50% Reduction of SIGH-D-17 Score From Baseline.

  Baseline to 8 Weeks

• Percentage of Treatment Responders at Week 8 Based on ≥ 50% Reduction of QIDS-SR16 Score From Baseline.

  Baseline to 8 Weeks

• Percentage of Treatment Responders at Week 8 Based on ≤ 3 Score on the CGI-I.

  Baseline to 8 Weeks

• Percentage of Remitters at Week 8 Based on ≤ 7 Score on the SIGH-D-17.

  Baseline to 8 Weeks

Study Arms (2)

Assay-guided treatment (AGT)

ACTIVE COMPARATOR

Assay results will be provided to the treating investigator, who will use the results to guide pharmacotherapy of the subject's MDD treatment.

Genetic: Assay-guided treatment (AGT)

Treatment-as-usual (TAU)

PLACEBO COMPARATOR

The treating investigator will treat subjects of the TAU group without the knowledge of the pharmacogenetic testing results.

Other: Treatment-as-usual (TAU)

Interventions

Assay-guided treatment (AGT) GENETIC

The assay provides information to guide pharmacotherapeutic decisions personalized to a patient's genetic profile, to maximize improvement in symptomatology and minimize treatment failure and treatment intolerability.

Also known as: Genecept Assay™

Assay-guided treatment (AGT)

Treatment-as-usual (TAU) OTHER

Subjects are treated-as-usual without the aid of the assay.

Treatment-as-usual (TAU)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Genomind, LLC: lead
• Medpace, Inc.: collaborator

Study Sites (23)

University of Alabama - Birmingham

Birmingham, Alabama, 35294, United States

Location

Noesis Pharma

Phoenix, Arizona, 85032, United States

Location

Woodland Research Northwest

Springdale, Arkansas, 72764, United States

Location

Collaborative Neuroscience Network, Inc. - Garden Grove

Garden Grove, California, 92845, United States

Location

Pacific Institute of Medical Research

Los Angeles, California, 90024, United States

Location

Pacific Research Partners, LLC

Oakland, California, 94612, United States

Location

Artemis Institute for Clinical Research

San Diego, California, 92103, United States

Location

Collaborative Neuroscience Network, Inc. - Torrance

Torrance, California, 90502, United States

Location

Pacific Clinical Research Medical Group

Upland, California, 91786, United States

Location

Florida Clinical Research Center, LLC - Bradenton

Bradenton, Florida, 34201, United States

Location

Clinical Neuroscience Solutions Inc. - Jacksonville

Jacksonville, Florida, 32256, United States

Location

Florida Clinical Research Center, LLC - Maitland

Maitland, Florida, 32751, United States

Location

Clinical Neuroscience Solutions Inc. - Orlando

Orlando, Florida, 32801, United States

Location

Chicago Research Center, Inc.

Chicago, Illinois, 60634, United States

Location

Boston Clinical Trials

Boston, Massachusetts, 02131, United States

Location

Premier Psychiatric Research Institute, LLC

Lincoln, Nebraska, 68526, United States

Location

Richard H Weisler MD, PA and Associates

Raleigh, North Carolina, 27609, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, 45417, United States

Location

IPS Research Company

Oklahoma City, Oklahoma, 73103, United States

Location

Thomas Jefferson University Mood Disorder Program

Philadelphia, Pennsylvania, 19107, United States

Location

Clinical Neuroscience Solutions Inc. - Memphis

Memphis, Tennessee, 38119, United States

Location

BioBehavioral Research of Austin, PC

Austin, Texas, 78759, United States

Location

University of Virginia Center for Psychiatric Research

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Genomind

dkrause@genomind.com

267-989-3461

Study Officials

• David Krause, MD

  Genomind CMO

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2015
• First Posted: December 17, 2015
• Study Start: January 1, 2016
• Primary Completion: July 25, 2017
• Study Completion: July 25, 2017
• Last Updated: August 28, 2020
• Results First Posted: August 28, 2020

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (23)