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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03228953
Recruitment Status : Recruiting
First Posted : July 25, 2017
Last Update Posted : August 4, 2017
Information provided by (Responsible Party):
Joseph Finkelstein, Columbia University

Tracking Information
First Submitted Date  ICMJE July 21, 2017
First Posted Date  ICMJE July 25, 2017
Last Update Posted Date August 4, 2017
Estimated Study Start Date  ICMJE August 2017
Estimated Primary Completion Date May 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 21, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2017)
  • 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).
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Pharmacogenomic Testing in Major Depressive Disorder
Official Title  ICMJE Impact of Comprehensive Pharmacogenomic Testing on the Treatment of Major Depressive Disorder
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE Other: Pharmacogenomic testing
Pharmacogenomic testing is delivered to treating providers of patients with major depressive disorder
Study Arms  ICMJE
  • 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.
    Intervention: Other: Pharmacogenomic testing
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 21, 2017)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 15, 2021
Estimated Primary Completion Date May 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sinan Zhu, PhD 212-342-0701
Contact: Manuel Cabrera, MD 646-317-0127
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03228953
Other Study ID Numbers  ICMJE AAAR4283
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Joseph Finkelstein, Columbia University
Study Sponsor  ICMJE Columbia University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joseph Finkelstein, MD, PhD Columbia University
PRS Account Columbia University
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP