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Pharmacogenomic Testing in Major Depressive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03228953
Recruitment Status : Unknown
Verified August 2017 by Joseph Finkelstein, Columbia University.
Recruitment status was:  Recruiting
First Posted : July 25, 2017
Last Update Posted : August 4, 2017
Information provided by (Responsible Party):
Joseph Finkelstein, Columbia University

Brief Summary:
This is a two-arm double-blind prospective randomized controlled trial (RCT) to evaluate clinical impact of pharmacogenomic testing on the treatment of major depressive disorder. Participants will be randomly assigned to two groups: pharmacogenomic-guided therapy group (guided group) and treatment as usual group (TAU group). The primary hypothesis is the pharmacogenomic-guided treatment group will demonstrate significantly higher percent improvement in depression score compared to treatment-as-usual group.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Other: Pharmacogenomic testing Not Applicable

Detailed Description:
To a large extent, variability in antidepressant efficacy can be explained by genetic variations that affect medication-metabolizing enzymes, drug transporters, and medication targets. Recent reviews demonstrated significant potential of pharmacogenomic testing in improving treatment of major depressive disorder. One of the major barriers towards successful implementation of pharmacogenomic testing for patients with major depressive disorder is lack of systematic evaluation of impact of this approach in routine clinical care settings. The major goal of this study is to systematically evaluate impact of comprehensive pharmacogenomic testing on the treatment of major depressive disorder in ambulatory setting.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Impact of Comprehensive Pharmacogenomic Testing on the Treatment of Major Depressive Disorder
Estimated Study Start Date : August 2017
Estimated Primary Completion Date : May 15, 2021
Estimated Study Completion Date : May 15, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Pharmacogenomic-guided therapy group
In this group, results of pharmacogenomic testing will be provided to the treating physician within 2-5 working days. Thus, the patient's treatment provider will be able begin antidepressant adjustments based on pharmacogenomic testing report within a week of the baseline visit.
Other: Pharmacogenomic testing
Pharmacogenomic testing is delivered to treating providers of patients with major depressive disorder

No Intervention: Treatment as usual (TAU) group
For patients randomized to this group, medication treatment decisions by the treating clinicians will be made without the availability of the pharmacogenomic report; however, the test results will be provided after the study completion to the patient treating physician.

Primary Outcome Measures :
  1. Score on the Hamilton Rating Scale for Depression (HAMD-17) [ Time Frame: Up to 10 weeks ]
    The patient is rated by a clinician among 17 dimensions with a score on a 3 or 5 point scale. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression, and are usually required for entry into a clinical trial.

Secondary Outcome Measures :
  1. Score on Subject-Rated 16-item Quick Inventory of Depression Symptomatology Scales (QIDS-SR) [ Time Frame: Up to 10 weeks ]
    The Quick Inventory of Depressive Symptomatology is a short screening tool based on the larger Inventory of Depressive Symptomatology (IDS). Each item is scored on a scale from 0 to 3 points. Total scores range from 0 (no depression) to 27 (severe depression).

  2. Score on the 9-item Patient Health Questionnaire (PHQ-9) [ Time Frame: Up to 10 weeks ]
    The PHQ-9 is the depression module, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day). Higher PHQ-9 scores are associated with decreased functional status and increased symptom-related difficulties, sick days and healthcare utilization.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Clinical diagnosis of major depressive disorder (MDD)
  2. Prescription of index antidepressant medications
  3. Minimum score of 14 on the 17-item Hamilton Rating Scale for Depression (HAMD-17)

Exclusion Criteria:

  1. Diagnosis of bipolar disorder (any type), schizophrenia, or schizoaffective disorders
  2. Active diagnosis of substance abuse or dependence
  3. Current suicidal ideation
  4. Previous suicidal attempts
  5. A person has already had pharmacogenetic testing done.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03228953

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Contact: Sinan Zhu, PhD 212-342-0701
Contact: Manuel Cabrera, MD 646-317-0127

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United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
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Principal Investigator: Joseph Finkelstein, MD, PhD Columbia University
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Responsible Party: Joseph Finkelstein, Associate Professor of Dental Bioinformatics, Columbia University Identifier: NCT03228953    
Other Study ID Numbers: AAAR4283
First Posted: July 25, 2017    Key Record Dates
Last Update Posted: August 4, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Joseph Finkelstein, Columbia University:
Pharmacogenomic testing
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms